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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01939158




Registration number
NCT01939158
Ethics application status
Date submitted
29/08/2013
Date registered
11/09/2013

Titles & IDs
Public title
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
Scientific title
A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES
Secondary ID [1] 0 0
C0921003
Secondary ID [2] 0 0
MENACWY-TT-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infections, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Meningococcal vaccine GSK134612
Treatment: Other - Prevenar 13™

Experimental: ACWY1d group - Subjects will receive 1 dose of the MenACWY-TT vaccine

Experimental: ACWY2d group - Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart

Experimental: Co-ad group - Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™

Active comparator: PCV-13 group - Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later


Treatment: Other: Meningococcal vaccine GSK134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Treatment: Other: Prevenar 13™
1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
Timepoint [1] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Primary outcome [2] 0 0
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
Timepoint [2] 0 0
1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
Primary outcome [3] 0 0
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
Timepoint [3] 0 0
At Year 1
Primary outcome [4] 0 0
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
Timepoint [4] 0 0
At Year 1
Primary outcome [5] 0 0
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
Timepoint [5] 0 0
At Year 3
Primary outcome [6] 0 0
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
Timepoint [6] 0 0
At Year 3
Primary outcome [7] 0 0
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
Timepoint [7] 0 0
At Year 5
Primary outcome [8] 0 0
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
Timepoint [8] 0 0
At Year 5
Primary outcome [9] 0 0
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
Timepoint [9] 0 0
1 month after administration of Prevnar 13 (i.e. at Month 1)
Secondary outcome [1] 0 0
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
Timepoint [1] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Secondary outcome [2] 0 0
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
Timepoint [2] 0 0
1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
Secondary outcome [3] 0 0
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
Timepoint [3] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Secondary outcome [4] 0 0
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
Timepoint [4] 0 0
1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
Secondary outcome [5] 0 0
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
Timepoint [5] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
Secondary outcome [6] 0 0
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
Timepoint [6] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
Secondary outcome [7] 0 0
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
Timepoint [7] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Secondary outcome [8] 0 0
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
Timepoint [8] 0 0
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Secondary outcome [9] 0 0
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
Timepoint [9] 0 0
At Year 1, Year 3, Year 5
Secondary outcome [10] 0 0
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
Timepoint [10] 0 0
At Year 1, Year 3, Year 5
Secondary outcome [11] 0 0
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
Timepoint [11] 0 0
At Year 1, Year 3, Year 5
Secondary outcome [12] 0 0
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
Timepoint [12] 0 0
At Year 1, Year 3, Year 5
Secondary outcome [13] 0 0
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
Timepoint [13] 0 0
1 month after administration of Prevnar 13 (i.e. at Month 1)
Secondary outcome [14] 0 0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
Timepoint [14] 0 0
1 month after administration of Prevnar 13 (i.e. at Month 1)
Secondary outcome [15] 0 0
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
Timepoint [15] 0 0
1 month after administration of Prevnar 13 (i.e. at Month 1)
Secondary outcome [16] 0 0
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
Timepoint [16] 0 0
Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])
Secondary outcome [17] 0 0
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
Timepoint [17] 0 0
Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])
Secondary outcome [18] 0 0
Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)
Timepoint [18] 0 0
Within 31 days post any vaccination
Secondary outcome [19] 0 0
Number of Participants With Serious Adverse Events From Month 0 to Month 9
Timepoint [19] 0 0
Month 0 to Month 9
Secondary outcome [20] 0 0
Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study
Timepoint [20] 0 0
Baseline up to end of study (up to 5 years)
Secondary outcome [21] 0 0
Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9
Timepoint [21] 0 0
Month 0 to Month 9

Eligibility
Key inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.
Minimum age
12 Months
Maximum age
14 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Previous vaccination against Neisseria meningitidis.
* Previous booster vaccination against Streptococcus pneumoniae.
* Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
* History of meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*

* Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
* Acute disease and/or fever at the time of enrollment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2019
Sample size
Target
Accrual to date
Final
803
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
The Childrens Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [4] 0 0
Vaccine and Immunization Research Group - Melbourne
Recruitment hospital [5] 0 0
Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3010 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
Nova Scotia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Czechia
State/province [5] 0 0
Vokovice
Country [6] 0 0
Czechia
State/province [6] 0 0
Benesov
Country [7] 0 0
Czechia
State/province [7] 0 0
Boletice nad Labem
Country [8] 0 0
Czechia
State/province [8] 0 0
Brandys nad Labem
Country [9] 0 0
Czechia
State/province [9] 0 0
Caslav
Country [10] 0 0
Czechia
State/province [10] 0 0
Chrastava
Country [11] 0 0
Czechia
State/province [11] 0 0
Chrudim 2
Country [12] 0 0
Czechia
State/province [12] 0 0
Decin
Country [13] 0 0
Czechia
State/province [13] 0 0
Domazlice
Country [14] 0 0
Czechia
State/province [14] 0 0
Holice
Country [15] 0 0
Czechia
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czechia
State/province [16] 0 0
Hradek nad Nisou
Country [17] 0 0
Czechia
State/province [17] 0 0
Hronov
Country [18] 0 0
Czechia
State/province [18] 0 0
Jindrichuv Hradec
Country [19] 0 0
Czechia
State/province [19] 0 0
Kladno
Country [20] 0 0
Czechia
State/province [20] 0 0
Krupka
Country [21] 0 0
Czechia
State/province [21] 0 0
Liberec 7
Country [22] 0 0
Czechia
State/province [22] 0 0
Melnik
Country [23] 0 0
Czechia
State/province [23] 0 0
Nachod
Country [24] 0 0
Czechia
State/province [24] 0 0
Neveklov
Country [25] 0 0
Czechia
State/province [25] 0 0
Novy Jicin
Country [26] 0 0
Czechia
State/province [26] 0 0
Odolena Voda
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrov Nad Ohri
Country [28] 0 0
Czechia
State/province [28] 0 0
Ostrov
Country [29] 0 0
Czechia
State/province [29] 0 0
Pardubice
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha 3
Country [31] 0 0
Czechia
State/province [31] 0 0
Praha 5
Country [32] 0 0
Czechia
State/province [32] 0 0
Smirice
Country [33] 0 0
Czechia
State/province [33] 0 0
Trutnov
Country [34] 0 0
Czechia
State/province [34] 0 0
Tynec nad Sazavou
Country [35] 0 0
Panama
State/province [35] 0 0
Panama
Country [36] 0 0
South Africa
State/province [36] 0 0
Gauteng
Country [37] 0 0
Turkey
State/province [37] 0 0
Sihhiye
Country [38] 0 0
Turkey
State/province [38] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01939158