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Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496093
First received: July 3, 2007
Last updated: February 6, 2015
Last verified: February 2015
  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: 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 >= 2 fold 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
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumococcal Vaccine, Polyvalent (23-valent)
Participants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1.
Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Other Names:
  • V110
  • PNEUMOVAX™ 23

Detailed Description:

This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.

  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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496093     History of Changes
Other Study ID Numbers: V110-011, 2007_018
Study First Received: July 3, 2007
Last Updated: February 6, 2015
Health Authority: India: Drugs Controller General of India (DCGI)

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

ClinicalTrials.gov processed this record on March 03, 2015