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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00127855
Registration number
NCT00127855
Ethics application status
Date submitted
8/08/2005
Date registered
9/08/2005
Titles & IDs
Public title
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
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Scientific title
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity (Including Immune Memory), Reactogenicity and Safety of Three Different Formulations of the GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups CY Conjugate Vaccine Given Concomitantly With Infanrix® Penta and Prevenar®, Versus ActHIB® and Meningitec® Given Concomitantly With Infanrix® Penta and Versus ActHIB® Given Concomitantly With Infanrix® Penta and Prevenar® in Infants According to a 2-4-6 Month Schedule.
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Secondary ID [1]
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792014/002
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Secondary ID [2]
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792014/001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Haemophilus Influenzae Type b
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Neisseria Meningitidis
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Hib-MenCY-TT vaccine (MenHibrix)
Treatment: Other - Meningitec®
Treatment: Other - ActHIB®
Treatment: Other - Infanrix® Penta
Treatment: Other - Prevenar®
Treatment: Other - Mencevax® ACWY
Treatment: Other - PRP (Polyribosyl Ribitol Phosphate)
Experimental: MenHibrix Formulation 1 Group - Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Experimental: MenHibrix Formulation 2 Group - Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Experimental: MenHibrix Formulation 3 Group - Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Active comparator: Menjugate Group - Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Active comparator: ActHIB Group - Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
Treatment: Other: Hib-MenCY-TT vaccine (MenHibrix)
Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively
Treatment: Other: Meningitec®
Three doses were administered IM in right lower thigh at Months 0,2 and 4.
Treatment: Other: ActHIB®
Three doses were administered IM in left thigh at Months 0,2 and 4.
Treatment: Other: Infanrix® Penta
Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.
Treatment: Other: Prevenar®
Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.
Treatment: Other: Mencevax® ACWY
One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.
Treatment: Other: PRP (Polyribosyl Ribitol Phosphate)
One dose was administered IM in deltoid region of left arm at Month 10 as booster.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter
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Assessment method [1]
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The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
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Timepoint [1]
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One month after primary vaccination (Month 5)
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Primary outcome [2]
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Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
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Assessment method [2]
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The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [2]
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One month after primary vaccination (Month 5)
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Primary outcome [3]
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Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8
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Assessment method [3]
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The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [3]
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One month after primary vaccination (Month 5)
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Secondary outcome [1]
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Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
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Assessment method [1]
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The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [1]
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Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [2]
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Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
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Assessment method [2]
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Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [2]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [3]
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Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
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Assessment method [3]
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The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [3]
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Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [4]
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Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
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Assessment method [4]
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Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
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Timepoint [4]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [5]
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Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
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Assessment method [5]
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The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
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Timepoint [5]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [6]
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Anti-polysaccharide C (PSC) Antibody Concentration
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Assessment method [6]
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Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
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Timepoint [6]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [7]
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Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
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Assessment method [7]
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The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
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Timepoint [7]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [8]
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Anti-polysaccharide Y (PSY) Antibody Concentration
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Assessment method [8]
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Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
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Timepoint [8]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [9]
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Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
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Assessment method [9]
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The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
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Timepoint [9]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [10]
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Anti-PRP Antibody Concentration
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Assessment method [10]
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Concentrations are presented as GMCs and expressed as µg/mL.
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Timepoint [10]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)
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Secondary outcome [11]
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Number of Subjects Seroprotected for Anti-diphtheria Antibodies
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Assessment method [11]
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Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
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Timepoint [11]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [12]
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Anti-diphtheria Antibody Concentrations
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Assessment method [12]
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Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
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Timepoint [12]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [13]
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Number of Subjects Seroprotected for Anti-tetanus Antibodies
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Assessment method [13]
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Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
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Timepoint [13]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [14]
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Anti-tetanus Antibody Concentrations
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Assessment method [14]
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Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
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Timepoint [14]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [15]
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Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
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Assessment method [15]
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Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [15]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [16]
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Anti- FHA Antibody Concentrations
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Assessment method [16]
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [16]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [17]
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Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
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Assessment method [17]
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Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [17]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [18]
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Anti-PRN Antibody Concentrations
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Assessment method [18]
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [18]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [19]
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Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
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Assessment method [19]
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Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [19]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [20]
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Anti- PT Antibody Concentrations
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Assessment method [20]
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Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
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Timepoint [20]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [21]
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Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
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Assessment method [21]
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Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).
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Timepoint [21]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [22]
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Anti- HBs Antibody Concentrations
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Assessment method [22]
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Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).
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Timepoint [22]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [23]
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Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
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Assessment method [23]
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Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.
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Timepoint [23]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [24]
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Anti-poliovirus Types 1, 2 and 3 Antibody Titers
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Assessment method [24]
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Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.
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Timepoint [24]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [25]
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Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
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Assessment method [25]
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Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).
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Timepoint [25]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [26]
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Anti-pneumococcal Antibody Concentrations
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Assessment method [26]
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Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).
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Timepoint [26]
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Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)
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Secondary outcome [27]
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Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
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Assessment method [27]
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Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
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Timepoint [27]
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During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course
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Secondary outcome [28]
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Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
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Assessment method [28]
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Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
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Timepoint [28]
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During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose
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Secondary outcome [29]
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Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course
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Assessment method [29]
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Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Timepoint [29]
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During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course
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Secondary outcome [30]
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Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose
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Assessment method [30]
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Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Timepoint [30]
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During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose
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Secondary outcome [31]
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Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course
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Assessment method [31]
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Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Timepoint [31]
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Up to one month after the 3-dose primary vaccination course (Month 5)
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Secondary outcome [32]
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Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose
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Assessment method [32]
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Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Timepoint [32]
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Up to one month following administration of the polysaccharide challenge dose (Month 11)
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Eligibility
Key inclusion criteria
Inclusion criteria:
* A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Vaccinated against hepatitis B at birth.
* Born after a gestation period of 36 - 42 weeks.
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Minimum age
6
Weeks
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Maximum age
12
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria:
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth
* Any chronic drug therapy to be continued during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine(s).
* Previous vaccination against diphtheria, tetanus, pertussis, polio, N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* History of or known exposure to diphtheria, tetanus, pertussis, polio, or invasive diseases due to N. meningitidis of serogroups C and Y, Haemophilus influenzae type b or Streptococcus pneumoniae.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/02/2004
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Sample size
Target
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Accrual to date
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Final
409
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - North Adelaide
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Recruitment hospital [2]
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GSK Investigational Site - Carlton
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Recruitment hospital [3]
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GSK Investigational Site - Subiaco
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment postcode(s) [3]
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6018 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.
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Trial website
https://clinicaltrials.gov/study/NCT00127855
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Trial related presentations / publications
Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25. T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00127855