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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521897
First received: September 14, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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°)

Condition Intervention Phase
Pneumococcal Vaccine
Streptococcus Pneumoniae
Biological: 7-valent vaccine injection
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance for Prevenar in Japan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The actual status of the usage of Prevenar in routine utilization. ・Vaccination record of Prevenar (month of age at each vaccination time, vaccination sites) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The actual status of the usage of Prevenar in routine utilization. ・The presence or absence of the other concomitant vaccines with Prevenar (name and vaccination sites of other concomitant vaccines) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of local reactions at the injection site [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Systemic reactions for each concomitant vaccine (especially fever more than 39C°) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 1142
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
7-valent vaccine injection
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Biological: 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.
Other Name: Prevenar, 7vPnC

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.

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521897

Locations
Japan
Yokoyama Children's Clinic
Kasuga, Fukuoka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521897     History of Changes
Other Study ID Numbers: 0887X1-4447, B1841005
Study First Received: September 14, 2011
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pneumococcal Vaccine
Prevenar
7-valent
Special Use-result surveillance

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014