N/A
Completed N=1,143
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Pneumococcal Vaccine · Streptococcus pneumoniae
Source: ClinicalTrials.gov NCT01521897 ↗
Enrolled (actual)
1,143
Serious AEs
1.8%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Adverse Reactions — 126 participants
Summary
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.
This surveillance will specifically focus on the occurrence of the following:
1. Local reactions at the injection site
2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reactions |
126 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
20 | — |
| SECONDARY Number of Participants With Injection Site Reactions |
46; 59; 0; 1 | — |
| SECONDARY Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination |
1; 1; 1; 0; 3; 0 | — |
| SECONDARY Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination |
6; 1; 3; 1; 8; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Infants at the age of more than 2 and less than 7 months
- Infants who have been vaccinated with Prevenar for the first time
- Infants expected to complete four vaccinations with Prevenar
Exclusion Criteria
Vaccination with Prevenar must not be given to any of the following;
- History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
- Evident pyrexia
- Evident serious acute disease
- Any other infants or children ineligible for vaccination
Data sourced from ClinicalTrials.gov (NCT01521897). 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.