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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

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NCT00475033

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Calgary, Alberta, T3B 6A8 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 2-month old infants (42 to 98 days)

- Available for the duration of the study and reachable by telephone

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00475033
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

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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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00475033
6096A1-3008
No
Not Provided
Not Provided
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, [email protected]
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

FOR MORE INFORMATION

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1-800-718-1021

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