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Trial record 1 of 1 for:    NCT00824655
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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

Tracking Information
First Submitted Date  ICMJE January 16, 2009
First Posted Date  ICMJE January 19, 2009
Results First Submitted Date  ICMJE June 17, 2011
Results First Posted Date  ICMJE July 18, 2011
Last Update Posted Date August 10, 2011
Study Start Date  ICMJE March 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2009)
Pneumococcal immune responses induced by 13vPnC when measured 1 month after the last scheduled dose of 13vPnC in each of 2 age groups [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2011)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2009)
Pneumococcal immune response induced by 13vPnC when measured 1 month after the infant dose of 13vPnC in group 1 [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures
 (submitted: August 4, 2011)
  • Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) [ Time Frame: Day 1 through Day 7 after vaccination ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) [ Time Frame: Day 1 through Day 7 after vaccination ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) [ Time Frame: Day 1 through 7 after vaccination ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) [ Time Frame: Day 1 through 7 after vaccination ]
    Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccines
Intervention  ICMJE
  • Biological: 13vPnC
    13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
  • Biological: 13vPnC
    13vPnC will be administered by intramuscular injection at approximately 12 months of age.
Study Arms  ICMJE
  • Experimental: Group 1
    Intervention: Biological: 13vPnC
  • Experimental: Group 2
    Intervention: Biological: 13vPnC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2011)
234
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2009)
230
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 140 Days to 392 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00824655
Other Study ID Numbers  ICMJE 6096A1-3012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Wyeth, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP