Last updated: 11/03/2018 10:03:23
Study to assess safety & immunogenicity of GSK Biologicals’ Boostrix (dTpa) vaccine vs. Chinese DT vaccine
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Boostrix (dTpa) vaccine and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years
Trial description: This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals’ reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Boostrix
Biological/vaccine: Chinese DT vaccine
Enrollment:
660
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Zhu F et al. (2010) Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix™). Human Vaccines. 6(3):263-269.
Medical condition
Diphtheria, acellular pertussis, Tetanus
Product
SB263855
Collaborators
Not applicable
Study date(s)
March 2007 to May 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 8 years
Accepts healthy volunteers
Yes
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
Exclusion criteria:
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-12-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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