Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

Vaccines, Pneumococcal Conjugate Vaccine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475033
• Other study ID #: 6096A1-3008
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2007
• Last updated: April 18, 2011
• Start date: June 2007
• Est. completion date: May 2009

Study information

• Verified date: April 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine
13-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.
• 7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine administered at 2-, 4-, 6-, and 12 months of age.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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®	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%.	1 month after the toddler dose of NeisVac-C® (13 months of age)	No
Secondary	Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	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.	1 month after the toddler dose (13 months of age)	No
Secondary	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	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%.	1 month after the 3-dose infant series (7 months of age)	No