Clinical trial NCT00574795: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 193
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series
timeFrame: one month after 3-dose infant series (at 7 months of age)
Secondary outcomes:
measure: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series
timeFrame: one mone month after 3-dose infant series (at 7 months of age)
measure: Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
timeFrame: one month after the toddler dose (at 12 - 15 months of age)
measure: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
timeFrame: one month after the toddler dose (at 12-15 months of age)
Other outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions
timeFrame: Within 7 days after each dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events
timeFrame: Within 7 days after each dose
Locations:
city: Nagoya-shi
country: Japan
state: Aichi
city: Toyohashi-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Matsuyama-shi
country: Japan
state: Ehime
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Maebaru-shi
country: Japan
state: Fukuoka
city: Asahikawa-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Yokosuka-shi
country: Japan
state: Kanagawa
city: Nangoku-shi
country: Japan
state: Kochi
city: Ise-shi
country: Japan
state: Mie
city: Tsu-shi
country: Japan
state: Mie
city: Yokkaichi-shi
country: Japan
state: Mie
city: Kurashiki-shi
country: Japan
state: Okayama
city: Meguro-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.