N/A N=1,143

Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Pneumococcal Vaccine · Streptococcus Pneumoniae

Bottom Line

View on ClinicalTrials.gov: NCT01521897 ↗

Enrolled (actual)

1,143

Serious AEs

1.8%

Results posted

Jan 2016

Primary outcome: Primary: Number of Participants With Adverse Reactions — 126 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: 7-valent vaccine injection (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2013

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	—

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°)

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

View full record on ClinicalTrials.gov →

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.