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

NCT ID: NCT01521897

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-04-30

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 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°)

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 reached.

Conditions

Pneumococcal Vaccine; Streptococcus Pneumoniae

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

7-valent vaccine injection

Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

7-valent vaccine injection

Intervention Type: BIOLOGICAL

For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.

Interventions

7-valent vaccine injection

For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.

Intervention Type: BIOLOGICAL

Other Intervention Names

Prevenar, 7vPnC

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Yokoyama Children's Clinic

Kasuga, Fukuoka, Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-4447&StudyName=Prevenar%20Special%20Use-result%20Surveillance%20in%20Japan%20%28Regulatory%20PostMarketing%20Commitment%20Plan%29%20

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Other Identifiers

B1841005

Identifier Type: OTHER

Identifier Source: secondary_id

0887X1-4447

Identifier Type: -

Identifier Source: org_study_id