Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00475033 | Completed Phase 3 Results

• 1 other identifier: 6096A1-3008
• Study Type: interventional
• Target: 603
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (6)

• 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

  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%.

  1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)

• 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

  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.

  1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)

• Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

  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%.

  1 month after the 3-dose infant series (7 months of age)

• Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

  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.

  1 month after the 3-dose Infant Series (7 months of age)

• 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

  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%.

  1 month after the 3-dose infant series (7 months of age)

• Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series

  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.

  1 month after the 3-dose infant series (7 months of age)

Secondary Outcomes (3)

• 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®

  1 month after the toddler dose of NeisVac-C® (13 months of age)

• Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  1 month after the toddler dose (13 months of age)

• 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

  1 month after the 3-dose infant series (7 months of age)

Other Outcomes (12)

• Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series

  1 month after the 3-dose infant series (7 months of age)

• Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series

  1 month after the 3-dose infant series (7 months of age)

• Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose

  1 month after the toddler dose (13 months of age)

Study Arms (2)

1

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

ACTIVE COMPARATOR

Biological: 7-valent pneumococcal conjugate vaccine

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

1

7-valent pneumococcal conjugate vaccine BIOLOGICAL

7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

2

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (11)

Unknown Facility

Calgary, Alberta, T3B 6A8, Canada

Location

Unknown Facility

Edmonton, Alberta, T5N 4A3, Canada

Location

Unknown Facility

Coquitlam, British Columbia, V3C 4J2, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R 8P8, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6H 3N1, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1M3, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3E 0W3, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Unknown Facility

Montreal, Quebec, H3H 1P3, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1C5, Canada

Location

Unknown Facility

Québec, Quebec, G1E 7G9, Canada

Location

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Canada, clintrialparticipation@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 17, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 21, 2011
• Results First Posted: June 4, 2010

Record last verified: 2011-04

Locations

CA (11)