A Study to Compare the Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in Healthy Volunteers (V114-002)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumococcal Infections
Intervention: Pneumococcal Conjugate Vaccine (V114) (Biological); Pneumococcal Polysaccharide Vaccine (Biological); Pneumococcal 13-Valent Conjugate Vaccine (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia
disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal
Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar
13) when administered to healthy adults 50 years of age or older.
Clinical Details
Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX 23) and Prevnar 13 (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Serotype-specific IgG geometric mean concentration (GMC) for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine
Secondary outcome: Serotype-specific geometric mean titer (GMT) by opsonophagocytic assay for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Without fever for 72 hours prior to vaccination
Exclusion Criteria:
- Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal
conjugate vaccine
- Known or suspected to be immunocompromised
- Functional or anatomic asplenia
- History of autoimmune disease
- Evidence of dementia or cognitive impairment
- Use of any immunosuppressive therapy
- Received a licensed non-live vaccine administered within the 14 days prior to receipt
of study vaccine or scheduled to receive any other licensed vaccine within 30 days
following receipt of study vaccine
- Received a licensed live virus vaccine within 30 days prior of receipt of study
vaccine or is scheduled to receive any other licensed vaccine within 30 days of
receipt of study vaccine
- Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of
study vaccine
- Received a blood transfusion or blood products within the 6 months before receipt of
study vaccine or scheduled to receive a blood transfusion or blood product within 30
days of receipt of study vaccine
- History of invasive pneumococcal disease or known history of other
culture-positive pneumococcal disease
- Received antibiotic therapy for any acute illness within 72 hours
before receipt of study vaccine
Locations and Contacts
Additional Information
Starting date: March 2012
Last updated: February 26, 2015
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