EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Evaluation of safety and efficacy through Post Market Surveillance for Infanrix™, the DTaP mixed vaccine
Trial description: The purpose of this study was to investigate the following questions through post-marketing surveillance:• Unknown/Unexpected adverse events and the serious adverse events.• The circumstances in which the adverse events occurred under the practical application.• Factors considered to have influence on safety.• Factors considered to have influence on efficacy.• Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of Subjects reporting Serious Adverse Events
Timeframe: Since the beginning of the study and during the entire study period (up to 6 years)
Number of subjects reporting solicited symptoms
Timeframe: During the 4-week follow-up period after each dose
Number of Subjects Reporting Unsolicited Adverse Events
Timeframe: Within the 31-day (Day 0-30) following vaccination.
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: GSK Biologicals' Infanrix™
Enrollment:
1258
Observational study model:
Cohort
Primary completion date:
2008-23-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Diphtheria, acellular pertussis, Tetanus
Product
SB208355
Collaborators
Not applicable
Study date(s)
August 2003 to June 2008
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- All children receiving Infanrix™ were eligible for this survey.
Inclusion and exclusion criteria
Inclusion criteria:
- All children receiving Infanrix™ were eligible for this survey.
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
Finalized
Actual primary completion date
2008-23-06
Actual study completion date
2008-23-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
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