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Trial record 1 of 1 for:    NCT00708682
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Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

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ClinicalTrials.gov Identifier: NCT00708682
Recruitment Status : Completed
First Posted : July 2, 2008
Results First Posted : February 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE June 27, 2008
First Posted Date  ICMJE July 2, 2008
Results First Submitted Date  ICMJE January 28, 2011
Results First Posted Date  ICMJE February 25, 2011
Last Update Posted Date October 25, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
Assessment of pneumococcal immune response after a three dose infant vaccination series. [ Time Frame: Serum pneumococcal immune response at approximately seven months of age. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
  • 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) ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
Assessment of pneumococcal immune response after the second dose of the infant vaccination series. [ Time Frame: Serum pneumococcal immune response at approximately thirteen months of age. ]
Current Other Pre-specified Outcome Measures
 (submitted: January 28, 2011)
  • Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series [ Time Frame: Dose 2 of infant series (4 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) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
  • GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series [ Time Frame: Dose 3 of 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
  • GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose [ Time Frame: Toddler Dose (12 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.
  • Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 of Infant Series (2 months of age) ]
    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 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 of Infant Series (4 months of age) ]
    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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (6 months of age) ]
    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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]
    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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 of Infant Series (2 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 of Infant Series (4 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 of Infant Series (6 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be 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 Infants in Mexico
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE Biological: 13-valent pneumococcal conjugate vaccine
Study Arms  ICMJE Experimental: A
Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Publications * Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinón-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

*   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: January 28, 2011)
225
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2008)
214
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708682
Other Study ID Numbers  ICMJE 6096A1-3009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2011

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