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

August 2, 2005
January 28, 2015
March 2005
May 2005   (final data collection date for primary outcome measure)
Immunogenicity
Not Provided
Complete list of historical versions of study NCT00127153 on ClinicalTrials.gov Archive Site
Safety
Not Provided
Not Provided
Not Provided
 
A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
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
The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Healthy
  • Pneumococcal Infections
Biological: V110, pneumococcal vaccine polyvalent
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00127153
V110-013, 2005_039
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP