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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Nagoya-shi, Aichi, 466-8650 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-6 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 2 to 6 month-old infant

- Available for entire study period

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

- Previous vaccination with licensed or investigational pneumococcal vaccine.

- Previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with a pneumococcal conjugate vaccine.

- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate any type of injection.

- Known or suspected immune deficiency or suppression.

NCT00574795
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13vPnC
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
Not Provided
Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy 2 to 6 month-old infant
  • Available for entire study period

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with a pneumococcal conjugate vaccine.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • Known or suspected immune deficiency or suppression.
Sexes Eligible for Study: All
2 Months to 6 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00574795
6096A1-3003
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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[email protected]



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