N/A
N=1,258
Post Market Surveillance for Infanrix™
Diphtheria · Acellular Pertussis · Tetanus
Bottom Line
View on ClinicalTrials.gov: NCT00908115 ↗Enrolled (actual)
1,258
Serious AEs
0.2%
Results posted
Jul 2009
Primary outcome: Primary: Number of Subjects Reporting Serious Adverse Events — 3 Subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- GSK Biologicals' Infanrix™ (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Serious Adverse Events |
3 | — |
| PRIMARY Number of Subjects Reporting Solicited Symptoms |
51; 72; 86; 19; 5; 5 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events |
144 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
All children receiving Infanrix™ were eligible for this survey.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00908115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.