Full Text View
Tabular View
No Study Results Posted
Related Studies
Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
This study has been completed.
First Received: August 25, 2006   Last Updated: July 31, 2009   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00368966
  Purpose

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


Condition Intervention Phase
Vaccines, Pneumococcal
 Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7 valent pneumococcal conjugate vaccine
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
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 Spain

Resource links provided by NLM:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines
U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • To compare immunogenicity of 13vPnC to Prevenar using serotype specific serum IgG antibody levels; to evaluate immunogenicity of antigens in concomitant vaccines; to assess safety by local injection site reactions and systemic events, and adverse events. [ Time Frame: 5, 7 & 16 months ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: 13-valent Pneumococcal Conjugate Vaccine
2: Active Comparator Biological: 7 valent pneumococcal conjugate vaccine

  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
  • Available for the entire study period

Exclusion criteria:

  • Previous vaccination with any vaccine before the start of the study
  • Known contraindication to vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368966

  Show 42 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 6096A1-501
Study First Received: August 25, 2006
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00368966     History of Changes
Health Authority: Spain: Spanish Agency of Medicines;   United States: Food and Drug Administration

Keywords provided by Wyeth:
Pneumococcal
Pediatric
Vaccine

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on August 12, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services