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Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496093
First received: July 3, 2007
Last updated: March 3, 2008
Last verified: March 2008
History of Changes
  Purpose

To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.


Condition Intervention Phase
Pneumococcal Infection
 Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percentage of subjects exhibiting a >= 2fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b [ Time Frame: post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any AE within 15 days after vaccination, with particular attention to injection site AE and fever [ Time Frame: 15 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: October 2005
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
    Subjects received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to the vaccination on Day 1 and on Day 28 (±7 days) postvaccination.
    Other Names:
    • V110
    • PNEUMOVAX™ 23
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy indian adults of 50 years of age
  • In good health; any underlying chronic illness must be documented to be in stable condition
  • Signed and dated informed consent prior to receipt of the study vaccine

Exclusion Criteria:

  • Functional or anatomic asplenia
  • History of auto immune disease
  • Hypersensitivity to any of the components of the study vaccine,including phenol
  • Known or suspected immune dysfunction, including persons with congenital immunodeficiency
  • Prior vaccination with any pneumococcal vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496093

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00496093     History of Changes
Other Study ID Numbers: 2007_018, V110-011
Study First Received: July 3, 2007
Last Updated: March 3, 2008
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013