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

Phase 2

Completed

• Conditions: Pneumococcal Vaccine
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 7-valent pneumococcal conjugate vaccine

• Registration Number: NCT00689351
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-29
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-10
• Results First Submitted QC: 2010-12-10
• Results First Posted: 2011-01-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	13-valent pneumococcal conjugate vaccine	13vPnC
2	7-valent pneumococcal conjugate vaccine	7vPnC

Primary Outcome Measures

Name	Time	Method
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	1 month after the infant series (7 months of age)	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose	1 month after the toddler dose (13 months of age)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Seoul, Yeongdeungpo-gu, Korea, Republic of