N/A
Completed N=1,258
Post Market Surveillance for Infanrix™
Diphtheria · Acellular Pertussis · Tetanus
Source: ClinicalTrials.gov NCT00908115 ↗
Enrolled (actual)
1,258
Serious AEs
0.2%
Results posted
Jul 2009
Primary outcomePrimary: Number of Subjects Reporting Serious Adverse Events — 3 Subjects
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.
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 | — |
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. Informational only — not medical advice.