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

Wyeth is now a wholly owned subsidiary of Pfizer193 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

193

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Interventions

13vPnCBIOLOGICAL

"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

Sex: ALLMin age: 2 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (24)

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Toyohashi, Aichi-ken, Japan

Outcomes

Primary Outcomes

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.

Time frame: one month after 3-dose infant series (at 7 months of age)

Secondary Outcomes

Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series

GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.

Time frame: 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

Time frame: 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

Time frame: one month after the toddler dose (at 12-15 months of age)

Data from ClinicalTrials.gov

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