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
1 other identifier
interventional
193
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2007
Shorter than P25 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
August 8, 2012
CompletedAugust 8, 2012
June 1, 2012
11 months
December 13, 2007
March 26, 2010
June 28, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
one month after 3-dose infant series (at 7 months of age)
Secondary Outcomes (3)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
one mone month after 3-dose infant series (at 7 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
one month after the toddler dose (at 12 - 15 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
one month after the toddler dose (at 12-15 months of age)
Other Outcomes (2)
Percentage of Participants Reporting Pre-Specified Local Reactions
Within 7 days after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Within 7 days after each dose
Interventions
"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"
Eligibility Criteria
You may qualify if:
- Healthy 2 to 6 month-old infant
- Available for entire study period
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Nagoya, Aichi-ken, 466-8650, Japan
Unknown Facility
Toyohashi, Aichi-ken, 441-8570, Japan
Unknown Facility
Chiba, Chiba, 261-0012, Japan
Unknown Facility
Matsuyama, Ehime, 790-8524, Japan
Unknown Facility
Fukuoka, Fukuoka, 811-1394, Japan
Unknown Facility
Fukuoka, Fukuoka, 813-0036, Japan
Unknown Facility
Fukuoka, Fukuoka, 814-0162, Japan
Unknown Facility
Fukuoka, Fukuoka, 819-0002, Japan
Unknown Facility
Maebaru-shi, Fukuoka, 819-1138, Japan
Unknown Facility
Asahikawa-shi, Hokkaido, 078-8211, Japan
Unknown Facility
Sapporo, Hokkaido, 006-0831, Japan
Unknown Facility
Sapporo, Hokkaido, 062-0931, Japan
Unknown Facility
Sapporo, Hokkaido, 063-0831, Japan
Unknown Facility
Yokohama, Kanagawa, 240-8555, Japan
Unknown Facility
Yokosuka-shi, Kanagawa, 238-8558, Japan
Unknown Facility
Nangoku-shi, Kochi, 783-8505, Japan
Unknown Facility
Ise-shi, Mie-ken, 516-0805, Japan
Unknown Facility
Tsu, Mie-ken, 514-025, Japan
Unknown Facility
Yokkaichi-shi, Mie-ken, 510-8561, Japan
Unknown Facility
Kurashiki-shi, Okayama-ken, 701-0192, Japan
Unknown Facility
Meguro-ku, Tokyo, 152-8902, Japan
Unknown Facility
Setagaya-ku, Tokyo, 154-0002, Japan
Unknown Facility
Setagaya-ku, Tokyo, 154-0017, Japan
Unknown Facility
Setagaya-ku, Tokyo, 157-8535, Japan
Related Publications (1)
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.
PMID: 23538524DERIVED
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 8, 2012
Results First Posted
August 8, 2012
Record last verified: 2012-06