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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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.
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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)
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Secondary ID [1]
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263855/035
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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:
Acellular Pertussis
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0
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Tetanus
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Diphtheria
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - INFANRIX
Other interventions - BOOSTRIX
Other interventions - HAVRIX
Other interventions: INFANRIX
Other interventions: BOOSTRIX
Other interventions: HAVRIX
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Intervention code [1]
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Other interventions
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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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Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Occurrence of local injection site reactions (1M after vacc).
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [1]
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Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
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Assessment method [2]
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0
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Timepoint [2]
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Secondary outcome [3]
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SAEs (full study).
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Assessment method [3]
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Timepoint [3]
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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.
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Minimum age
18
Months
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Maximum age
20
Months
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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
- 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.
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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?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
1/05/2003
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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
1/01/2004
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Sample size
Target
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Accrual to date
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Final
720
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Carlton
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Recruitment postcode(s) [1]
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3053 - Carlton
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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
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00544271
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00544271
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