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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127153
First received: August 2, 2005
Last updated: January 28, 2015
Last verified: January 2015
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 3

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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Immunogenicity

Secondary Outcome Measures:
  • Safety
Estimated Enrollment: 130
Study Start Date: March 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127153     History of Changes
Other Study ID Numbers: V110-013, 2005_039
Study First Received: August 2, 2005
Last Updated: January 28, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on March 03, 2015