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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Yokoyama Children's Clinic
Kasuga, Fukuoka, 816-0801 Japan
Contact
1-800-718-1021
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

NCT01521897
Pfizer
Completed
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

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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
1143
April 2015
January 2013   (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
Sexes Eligible for Study: All
2 Months to 2 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01521897
0887X1-4447
B1841005 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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