Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00708682
First received: June 27, 2008
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.


Condition Intervention Phase
Vaccines, Pneumococcal
Biological: 13-valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico

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 Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (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 predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series [ Time Frame: 1 month after dose 2 of the infant series (5 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 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. Exact 2-sided CI based on the observed proportion of participants.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 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 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. Exact 2-sided CI based on the observed proportion of participants.


Enrollment: 225
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: 13-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 infants, available for entire study period and parent/legal guardian reachable by telephone
  • Able to complete three blood draws during study
  • At least 3.5 kg at enrollment

Exclusion Criteria:

  • Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
  • Immune deficiency, bleeding disorder or significant chronic medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708682

Locations
Mexico
Guadalajara, Jalisco, Mexico, 44080
Morelia, Michoacan, Mexico, 58070
Cuernavaca, Morelos, Mexico, 62508
Monterrey, Nuevo Leon, Mexico, 64460
Merida, Yucatan, Mexico, 9700
Distrio Federal, Mexico, 14080
Distrio Federal, Mexico, 4530
Oaxaca, Mexico, 71220
Puebla, Mexico, 72190
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More 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: NCT00708682     History of Changes
Other Study ID Numbers: 6096A1-3009
Study First Received: June 27, 2008
Results First Received: January 28, 2011
Last Updated: October 24, 2011
Health Authority: Mexico: Ethics Committee
Mexico: National Institute of Public Health, Health Secretariat
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014