Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
NCT00574795
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- Healthy 2 to 6 month-old infant
- Available for entire study period
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants | |||
Official Title ICMJE | A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Vaccines, Pneumococcal Conjugate Vaccine | |||
Intervention ICMJE | 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" | |||
Study Arms ICMJE | Not Provided | |||
Publications * | 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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 193 | |||
Original Estimated Enrollment ICMJE | 165 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Months to 6 Months (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00574795 | |||
Other Study ID Numbers ICMJE | 6096A1-3003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |