Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00544271




Registration number
NCT00544271
Ethics application status
Date submitted
15/10/2007
Date registered
16/10/2007
Date last updated
7/09/2016

Titles & IDs
Public title
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Scientific title
Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)
Secondary ID [1] 0 0
263855/035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acellular Pertussis 0 0
Tetanus 0 0
Diphtheria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Occurrence of local injection site reactions (1M after vacc).
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
Timepoint [2] 0 0
Secondary outcome [3] 0 0
SAEs (full study).
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* Male or female children between and including 18 -20 months of age at the time of the vaccination.
* Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
* Written informed consent obtained before study entry from the parents or guardians of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Minimum age
18 Months
Maximum age
20 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
* Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.

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
Blinded (masking 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2004
Sample size
Target
Accrual to date
Final
720
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton

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

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
Trial website
https://clinicaltrials.gov/study/NCT00544271
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00544271