Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00824655
First received: January 16, 2009
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.


Condition Intervention Phase
Pneumococcal Vaccines
Biological: 13vPnC
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose [ Time Frame: 1 Month after the infant series (6 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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.

  • GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose [ Time Frame: 1 Month after the infant series (6 months of age) ] [ Designated as safety issue: No ]
    Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.

  • GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose [ Time Frame: 12 months of age (prior to toddler dose) ] [ Designated as safety issue: No ]
    Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.


Enrollment: 234
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: 13vPnC
13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
Experimental: Group 2 Biological: 13vPnC
13vPnC will be administered by intramuscular injection at approximately 12 months of age.

  Eligibility

Ages Eligible for Study:   140 Days to 392 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children previously immunized with 1 or 2 doses of Prevenar.
  • Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
  • Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
  • Available for entire study period.

Exclusion Criteria:

  • Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
  • Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824655

Locations
Sweden
Pfizer Investigational Site
Eskilstuna, Sweden, SE-63188
Pfizer Investigational Site
Goteborg, Sweden, SE-40014
Pfizer Investigational Site
Malmo, Sweden, SE-20502
Pfizer Investigational Site
Orebro, Sweden, SE-70185
Pfizer Investigational Site
Ostersund, Sweden, SE-83183
Pfizer Investigational Site
Uddevalla, Sweden, SE-45180
Pfizer Investigational Site
Umea, Sweden, SE-90185
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier: NCT00824655     History of Changes
Other Study ID Numbers: 6096A1-3012
Study First Received: January 16, 2009
Results First Received: June 17, 2011
Last Updated: August 4, 2011
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Pfizer:
Healthy Subjects
Vaccines
Pneumococcal

ClinicalTrials.gov processed this record on July 31, 2014