Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01174849




Registration number
NCT01174849
Ethics application status
Date submitted
2/08/2010
Date registered
4/08/2010
Date last updated
18/10/2018

Titles & IDs
Public title
Pneumococcal Vaccines Early and in Combination
Scientific title
A Randomised Controlled Trial of Pneumococcal Conjugate Vaccines Synflorix and Prevenar13 in Sequence or Alone in High-risk Indigenous Infants (PREV-IX_COMBO): Immunogenicity, Carriage and Otitis Media Outcomes
Secondary ID [1] 0 0
ACTRN12610000544077
Secondary ID [2] 0 0
605810
Universal Trial Number (UTN)
Trial acronym
PREVIX_COMBO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders
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: Drugs - Synflorix
Treatment: Drugs - Prevenar13
Treatment: Drugs - COMBO

Active comparator: Synflorix -

Active comparator: Prevenar13 -

Experimental: COMBO - COMBINATION SCHEDULE of comparator vaccine 1 and comparator vaccine 2 Synflorix at 1,2,4 months then Prevenar13 at 6 months.


Treatment: Drugs: Synflorix
The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.

Treatment: Drugs: Prevenar13
The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.

Active ingredients

Each 0.5 mL dose contains:

2.2 µg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 µg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg). CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (ß197) grown in a casamino acids and yeast extract-based medium.

Treatment: Drugs: COMBO
COMBINATION SCHEDULE of vaccine 1 and vaccine 2: Synflorix (PHiD-CV) at 1,2,4 months then Prevenar13 (PCV13) at 6 months of age.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immunogenicity
Timepoint [1] 0 0
7 months of age
Secondary outcome [1] 0 0
nasopharyngeal carriage
Timepoint [1] 0 0
7 months of age
Secondary outcome [2] 0 0
nasopharyngeal carriage
Timepoint [2] 0 0
7 months of age
Secondary outcome [3] 0 0
otitis media
Timepoint [3] 0 0
7 months of age

Eligibility
Key inclusion criteria
Indigenous infants

* 4 to 6 weeks of age
* Living in remote communities that have provided signed Expressions of Interest in participating in PREV-IX_COMBO trial
* Intend to remain in their community until their baby is 7 months of age
* Eligible for routine vaccinations.
Minimum age
28 Days
Maximum age
38 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Prior adverse reaction to pneumococcal conjugate vaccines according to Australian Immunization Handbook.
* Gestational age < 32 weeks

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 4
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
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2018
Sample size
Target
Accrual to date
Final
425
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0811 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Amanda J Leach, PhD
Address 0 0
Menzies School of Health Research
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

No information has been provided regarding IPD availability


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 not provided in https://clinicaltrials.gov/study/NCT01174849