Status:
COMPLETED
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Vaccine
Streptococcus Pneumoniae
Eligibility:
All Genders
2-2 years
Brief 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 ...
Detailed Description
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is rea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
1143 Patients enrolled
Trial Details
Trial ID
NCT01521897
Start Date
September 1 2010
End Date
April 1 2015
Last Update
January 20 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yokoyama Children's Clinic
Kasuga, Fukuoka, Japan, 816-0801