13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

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NCT02034877

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Study Location
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

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


Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine
within the last year

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Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India NCT02034877
  1. Visakhapatnam, Andhra Pradesh
  2. Ahmedabad, Gujarat
  3. Vadodara, Gujarat
  4. Bangalore, Karnataka
  5. Bangalore, Karnataka
  6. Hubli, Karnataka
  7. Mysore, Karnataka
  8. Chinchwad Pune, Maharashtra
  9. Nashik, Maharashtra
  10. Nasik, Maharashtra
  11. Pune, Maharashtra
  12. Pune, Maharashtra
  13. Vellore, Tamilnadu
  14. Varanasi, Uttar Pradesh
  15. Mumbai,
  16. Nagpur,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Official Title  ICMJE A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India
Brief Summary This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal conjugate vaccine
    1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
  • Procedure: Blood sample collection
    10 mL of blood will be collected just before and approximately 1 month after vaccination.
Study Arms  ICMJE Experimental: 1
Interventions:
  • Biological: 13-valent Pneumococcal conjugate vaccine
  • Procedure: Blood sample collection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)		1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion Criteria:

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034877
Other Study ID Numbers  ICMJE B1851140
2014-001174-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP