Acellular Pertussis, Tetanus, Diphtheria
Conditions
Keywords
BOOSTRIX, INFANRIX
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Months to 20 Months
Healthy volunteers
Yes
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc) | — |
| Occurrence of local injection site reactions (1M after vacc). | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc), | — |
| Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30), | — |
| SAEs (full study). | — |
Countries
Australia
Outcome results
None listed