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

Phase 3

Completed

• Conditions: Pneumococcal Infection
• Interventions: Biological: Pneumococcal Vaccine, Polyvalent (23-valent)

• Registration Number: NCT00496093
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pneumococcal Vaccine, Polyvalent (23-valent)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b	post-vaccination

Secondary Outcome Measures

Name	Time	Method
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever	15 days after vaccination