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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00475033
Date of registration:	15/05/2007
Prospective Registration:	Yes
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants
Scientific 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
Date of first enrolment:	June 2007
Target sample size:	603
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00475033
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Canada

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Canada, clintrialparticipation@wyeth.com

Name:	Medical Monitor
Address:
Telephone:
Email:
Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion 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

Age minimum: 42 Days
Age maximum: 98 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal Conjugate Vaccine

Intervention(s)

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 7-valent pneumococcal conjugate vaccine

Primary Outcome(s)

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)]

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)]

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)]

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)]

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)]

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)]

Secondary Outcome(s)

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)]

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)]

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)]

Secondary ID(s)

6096A1-3008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	04/06/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00475033

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