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Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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NCT00474539

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Almeria, , 4007 Spain
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 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

- Available for the entire study period

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

- Previous vaccination with any vaccine before the start of the study

- Known contraindication to vaccination

NCT00474539
Pfizer
Completed
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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Study Evaluating a 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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13-valent pneumococcal conjugate vaccine
    1 dose at 2,4,6 and 15 months of age
  • Biological: 7-valent pneumococcal conjugate vaccine
    1 dose at 2,4,6 and 15 months of age
  • Experimental: 1
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: 2
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinón-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
449
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy 2-month-old infants
  • Available for the entire study period

Exclusion criteria:

  • Previous vaccination with any vaccine before the start of the study
  • Known contraindication to vaccination
Sexes Eligible for Study: All
42 Days to 98 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00474539
6096A1-3007
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
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 Spain: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
January 2013

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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