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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Sector-12, Chandigarh, 160 012 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-72 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment

2. Available for the entire study period

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

1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines

2. A previous anaphylactic reaction to any vaccine or vaccine-related component

3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus,
pertussis, polio, hepatitis B or measles vaccines

NCT00452790
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose at 6, 10, 14 weeks and 12 months of age
  • Biological: 7 valent pneumococcal conjugate vaccine
    1 dose at 6, 10, 14 weeks and 12 months of age
  • Experimental: A
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: B
    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
708
February 2010
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment
  2. Available for the entire study period

Exclusion Criteria

  1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component
  3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Sexes Eligible for Study: All
42 Days to 72 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00452790
6096A1-011
Not Provided
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
Wyeth is now a wholly owned subsidiary of Pfizer
March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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