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

March 13, 2017 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
Time Frame: 15 days after vaccination
15 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V110-011
  • 2007_018

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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