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:

MedlinePlus related topics: Pneumococcal Infections

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

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 (Adult)
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


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 Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections	Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016

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