Last updated: 11/03/2018 09:50:46
Study to assess the safety & reactogenicity of GSK Biologicals’ dTpa vaccine (Boostrix) when given at 6-8 years of age.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Open, booster vaccination study to assess safety and reactogenicity of GSK Biologicals’ dTpa vaccine (Boostrix) when administered to healthy chinese children 6-8 years of age.
Trial description: This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals’ dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Boostrix
Enrollment:
30
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
Tetanus, Diphtheria, acellular pertussis
Product
SB263855
Collaborators
Not applicable
Study date(s)
January 2007 to February 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 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,
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,
Exclusion criteria:
- 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
2007-10-02
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website