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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496093
First received: July 3, 2007
Last updated: March 3, 2008
Last verified: March 2008
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496093

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 July 29, 2014