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
  Purpose

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.


Condition Intervention Phase
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
Biological: 7-valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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%.


Enrollment: 603
Study Start Date: June 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 13-valent Pneumococcal Conjugate Vaccine
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
Active Comparator: 2 Biological: 7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00475033

Locations
Canada, Alberta
Calgary, Alberta, Canada, T3B 6A8
Edmonton, Alberta, Canada, T5N 4A3
Canada, British Columbia
Coquitlam, British Columbia, Canada, V3C 4J2
Surrey, British Columbia, Canada, V3R 8P8
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 0W3
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Quebec
Montreal, Quebec, Canada, H3H 1P3
Montreal, Quebec, Canada, H3T 1C5
Quebec City, Quebec, Canada, G1E 7G9
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00475033     History of Changes
Other Study ID Numbers: 6096A1-3008
Study First Received: May 15, 2007
Results First Received: May 4, 2010
Last Updated: April 18, 2011
Health Authority: Canada: Ethics Review Committee
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 27, 2014