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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

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ClinicalTrials.gov Identifier: NCT00824655
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : July 18, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumococcal Vaccines Biological: 13vPnC Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose [ Time Frame: 12 months of age (prior to toddler dose) ]
    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.



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Ages Eligible for Study:   140 Days to 392 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier: NCT00824655     History of Changes
Other Study ID Numbers: 6096A1-3012
First Posted: January 19, 2009    Key Record Dates
Results First Posted: July 18, 2011
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
Healthy Subjects
Vaccines
Pneumococcal

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs