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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

September 14, 2011
July 23, 2014
September 2010
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01521897 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance for Prevenar in Japan)

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°)

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Pneumococcal Vaccine
  • Streptococcus Pneumoniae
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
7-valent vaccine injection
Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Intervention: Biological: 7-valent vaccine injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1142
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
2 Months to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01521897
0887X1-4447, B1841005
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP