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Boostrix vs Chinese DT vaccine booster in children
NCT00452686Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2007
- Countries
- 1
- Sponsor
- GSK
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- diphtheriaTetanuspertussis
01
Overview
Phase 3, randomised trial of Bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) in diphtheria, Tetanus and pertussis (2 arms), sponsored by GSK. Primary endpoint: Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration at 1 month. Started Mar 2007; status: completed.
02
Design
2 arms- Study design
- Randomized
Boostrix
Single dose of Boostrix (dTpa)
Chinese DT
Single dose of Chinese DT vaccine
03
Who it enrols
Healthy male or female children between 6 and 8 years of age. Exclusion criteria include subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life (ambiguous phrasing in source, possibly implies exclusion of those with recent boosters or specific prior history) and those with a history of diphtheria, pertussis, or tetanus diseases.
04
Endpoints
Primary
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration
Secondary
Solicited symptoms
Unsolicited adverse events
Serious Adverse Events
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