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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-01-31

Brief Summary

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

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Detailed Description

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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

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Pneumococcal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pneumococcal Vaccine, Polyvalent (23-valent)

Intervention Type BIOLOGICAL

Interventions

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Pneumococcal Vaccine, Polyvalent (23-valent)

Intervention Type BIOLOGICAL

Other Intervention Names

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V110 PNEUMOVAX™ 23

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes