Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00688870
First received: May 29, 2008
Last updated: October 31, 2011
Last verified: October 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 Taiwan.


Condition Intervention Phase
Vaccines
Pneumococcal Conjugate Vaccine
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
Phase 3

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: A Phase 3, 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 Taiwan

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 Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 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 a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after toddler dose (16 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 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.


Enrollment: 168
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13vPnC
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
Active Comparator: 2
7vPnC
Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 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 vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688870

Locations
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taoyuan Hsien, Taiwan, 333
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: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00688870     History of Changes
Other Study ID Numbers: 6096A1-3004, B1851005
Study First Received: May 29, 2008
Results First Received: January 13, 2011
Last Updated: October 31, 2011
Health Authority: Taiwan: National Bureau of Controlled Drugs

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

ClinicalTrials.gov processed this record on April 17, 2014