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

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NCT02034877

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002 India
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.
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

NCT02034877
Pfizer
Completed
13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

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13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
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
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.
Not Provided
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Prevention
Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
  • 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.
Experimental: 1
Interventions:
  • Biological: 13-valent Pneumococcal conjugate vaccine
  • Procedure: Blood sample collection
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT02034877
B1851140
2014-001174-34 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

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.

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1-800-718-1021

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Contact

[email protected]



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