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A Study of V110 a Pneumococcal Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00127153
First received: August 2, 2005
Last updated: July 26, 2006
Last verified: September 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
Pneumococcal Infections
 Biological: V110, pneumococcal vaccine polyvalent
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Immunogenicity

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 130
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127153

Locations
Japan
Call for Site Information
Tokyo, Chuoku, Japan, 103-8416
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127153     History of Changes
Other Study ID Numbers: 2005_039
Study First Received: August 2, 2005
Last Updated: July 26, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 17, 2013