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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00689351
First received: May 29, 2008
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Pneumococcal Vaccine
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    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.


Enrollment: 180
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13vPnC
Biological: 13-valent pneumococcal conjugate vaccine
13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Active Comparator: 2
7vPnC
Biological: 7-valent pneumococcal conjugate vaccine
7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689351

Locations
Korea, Republic of
Pfizer Investigational Site
Incheon, Bupyeong-gu, Korea, Republic of, 400-711
Pfizer Investigational Site
Seoul, Jongno-gu, Korea, Republic of, 110-744
Pfizer Investigational Site
Incheon, Jung-gu, Korea, Republic of, 400-711
Pfizer Investigational Site
Kyunggi, Koyang, Korea, Republic of, 412-270
Pfizer Investigational Site
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-950
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier: NCT00689351     History of Changes
Other Study ID Numbers: 6096A1-010, B1851001
Study First Received: May 29, 2008
Results First Received: December 10, 2010
Last Updated: June 24, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Prevention
against
pneumococcal
disease
Vaccine

ClinicalTrials.gov processed this record on April 17, 2014