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

NCT01521897

Last updated date
Study Location
Yokoyama Children's Clinic
Kasuga, Fukuoka, 816-0801, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccine, Streptococcus Pneumoniae
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Pneumococcal Vaccine, Streptococcus PneumoniaePrevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
NCT01521897
  1. Kasuga, Fukuoka
ALL GENDERS
2 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Official Title Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
Condition
  • Pneumococcal Vaccine
  • Streptococcus Pneumoniae
Intervention 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
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2015)
1143
Original Estimated Enrollment
 (submitted: January 26, 2012)
1000
Actual Study Completion Date April 2015
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 2 Months to 2 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01521897
Other Study ID Numbers 0887X1-4447
B1841005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2015