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NCT00127153 Clinical Trial

A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)

Healthy Clinical Trial

Official title:
A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127153
Other study ID # V110-013
Secondary ID 2005_039
Status Completed
Phase Phase 3
First received August 2, 2005
Last updated January 28, 2015
Start date March 2005
Est. completion date May 2005

Study information
Verified date January 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Males and females in good health, ages 20-40, with no history of pneumococcal vaccination

Exclusion Criteria:

- Subjects with a recent febrile illness

- Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• V110, pneumococcal vaccine polyvalent

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenicity
Secondary Safety
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