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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00475033
First received: May 15, 2007
Last updated: April 18, 2011
Last verified: April 2011

May 15, 2007
April 18, 2011
June 2007
May 2009   (final data collection date for primary outcome measure)
  • Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series [ Time Frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
  • Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series [ Time Frame: 1 month after 2 doses of NeisVac-C® in the infant series (7 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
  • Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
  • Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series [ Time Frame: 1 month after the 3-dose Infant Series (7 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
  • Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
  • Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
To compare immune response induced by infant series of routine pediatric vaccines (NeisVac-C and Pentacel) when given with 13vPnC compared to the immune response when given with 7vPnC. Also to evaluate safety profile of, and immune response to 13vPnC.
Complete list of historical versions of study NCT00475033 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C® [ Time Frame: 1 month after the toddler dose of NeisVac-C® (13 months of age) ] [ Designated as safety issue: No ]
    Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
  • Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.
  • Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series [ Time Frame: 1 month after the 3-dose infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.
To compare immune response induced following toddler dose of routine pediatric vaccines (NeisVac-C) when given with 13vPnC compared to the immune response when given with 7vPnC.
Not Provided
Not Provided
 
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Canada

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
  • Biological: 7-valent pneumococcal conjugate vaccine
    7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
  • Experimental: 1
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy 2-month old infants (42 to 98 days)
  • Available for the duration of the study and reachable by telephone

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
  • Receipt of blood products or gamma globulin
Both
42 Days to 98 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00475033
6096A1-3008
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

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