Last updated: 11/07/2018 15:12:42
A phase III, open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ dTpa-IPV vaccine when administered as a booster vaccination to healthy children aged 6-8 years and previously vaccinated with 4 doses of DTPw and at least 3 doses of OPV/ IPV vaccines.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase III, open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ dTpa-IPV vaccine when administered as a booster vaccination to healthy children aged 6-8 years and previously vaccinated with 4 doses of DTPw and at least 3 doses of OPV/ IPV vaccines.
Trial description: A phase III, open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ dTpa-IPV vaccine when administered as a booster vaccination to healthy children aged 6-8 years and previously vaccinated with 4 doses of DTPw and at least 3 doses of OPV/ IPV vaccines.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Lin et al. (2008) Booster vaccination at 6-8 years of age with a reduced antigen content dTpa-IPV vaccine is immunogenic and safe after priming with whole-cell pertussis vaccine. Human Vaccines. 4(1):50-53.
Medical condition
Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
Product
SB711866
Collaborators
Not applicable
Study date(s)
September 2003 to November 2003
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-28-11
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
Not applicable
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