Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00574795

Purpose

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.

Condition	Intervention	Phase
Vaccines, Pneumococcal Conjugate Vaccine	Biological: 13vPnC	Phase III

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

Further study details as provided by Wyeth:

Primary Outcome Measures:

Immunogenicity (serum IgG antibody levels) to the 13 pneumococcal conjugates induced by 13vPnC when measured 1 month after the infant series. [ Time Frame: 28 to 42 days after primary series (the 3rd vaccination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and immunogenicity after toddler dose. [ Time Frame: 28 to 42 days after toddlar dose (the 4th vaccination) ] [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

"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

Ages Eligible for Study:	2 Months to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574795

Locations

Japan, Aichi

Nagoya-shi, Aichi, Japan, 466-8650

Toyohashi-shi, Aichi, Japan, 441-8570
Japan, Chiba

Chiba-shi, Chiba, Japan, 261-0012
Japan, Ehime

Matsuyama-shi, Ehime, Japan, 790-8524
Japan, Fukuoka

Fukuoka-shi, Fukuoka, Japan, 811-1394

Fukuoka-shi, Fukuoka, Japan, 813-0036

Fukuoka-shi, Fukuoka, Japan, 819-0002

Fukuoka-shi, Fukuoka, Japan, 814-0162

Maebaru-shi, Fukuoka, Japan, 819-1138
Japan, Hokkaido

Sapporo-shi, Hokkaido, Japan, 006-0831

Sapporo-shi, Hokkaido, Japan, 062-0931

Asahikawa-shi, Hokkaido, Japan, 078-8211

Sapporo-shi, Hokkaido, Japan, 063-0831
Japan, Kanagawa

Yokohama-shi, Kanagawa, Japan, 240-8555

Yokosuka-shi, Kanagawa, Japan, 238-8558
Japan, Kochi

Nangoku-shi, Kochi, Japan, 783-8505
Japan, Mie

Tsu-shi, Mie, Japan, 514-025

Ise-shi, Mie, Japan, 516-0805

Yokkaichi-shi, Mie, Japan, 510-8561
Japan, Okayama

Kurashiki-shi, Okayama, Japan, 701-0192
Japan, Tokyo

Meguro-ku, Tokyo, Japan, 152-8902

Setagaya-ku, Tokyo, Japan, 154-0017

Setagaya-ku, Tokyo, Japan, 154-0002

Setagaya-ku, Tokyo, Japan, 157-8535

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6096A1-3003
Study First Received:	December 13, 2007
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00574795
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009