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

Merck Sharp & Dohme LLC133 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

133

Conditions

Pneumococcal Infection

Interventions

Pneumococcal Vaccine, Polyvalent (23-valent)BIOLOGICAL

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: 15 days after vaccination

Data from ClinicalTrials.gov

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