NCT00496093

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal Vaccine, Polyvalent (23-valent)

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2007-07-04
• Last updated: 2017-03-14