N/A
Completed N=3,214
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Source: ClinicalTrials.gov NCT00772369 ↗Enrolled (actual)
3,214
Serious AEs
2.9%
Results posted
Apr 2010
Primary outcomePrimary: Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series — 3023; 161; 149; 6 Particpants
Summary
The purpose of this survey is to collect selected safety data.
Primary Objective:
To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series |
3023; 161; 149; 6; 6; 29 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine. |
80; 6; 1; 1; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
- Written Informed Consent and Telephone consent from the parent(s) or guardian(s).
- Able to comply with the survey procedures.
Exclusion Criteria
- Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.
Data sourced from ClinicalTrials.gov (NCT00772369). 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.