Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

Wyeth is now a wholly owned subsidiary of Pfizer180 enrolled

Overview

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Pneumococcal Vaccine

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

7-valent pneumococcal conjugate vaccineBIOLOGICAL

7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

Eligibility

Sex: ALLMin age: 42 DaysMax age: 98 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy 2-month-old-infants (42 to 98 days) * Available for the entire study period (14 months) Exclusion Criteria: * Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine * A previous severe reaction to any vaccine or vaccine-related component

Locations (6)

Pfizer Investigational Site

Incheon, Bupyeong-gu, South Korea

Pfizer Investigational Site

Seoul, Jongno-gu, South Korea

Pfizer Investigational Site

Incheon, Jung-gu, South Korea

Pfizer Investigational Site

Kyunggi, Koyang, South Korea

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated 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).

Time frame: 1 month after the infant series (7 months of age)

Secondary Outcomes

Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose

Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated 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). Exact 2-sided CI was based on the observed percentage of participants.

Time frame: 1 month after the toddler dose (13 months of age)

Data from ClinicalTrials.gov

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