A Study to Compare the Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in Healthy Volunteers (V114-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01513551
First received: December 27, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infections
Biological: Pneumococcal Conjugate Vaccine (V114)
Biological: Pneumococcal Polysaccharide Vaccine
Biological: Pneumococcal 13-Valent Conjugate Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Serotype-specific IgG geometric mean concentration (GMC) for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serotype-specific geometric mean titer (GMT) by opsonophagocytic assay for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]

Enrollment: 692
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V114 Biological: Pneumococcal Conjugate Vaccine (V114)
Single intramuscular injection of V114 (0.5 mL) on Day 1
Active Comparator: Pneumococcal Polysaccharide Vaccine Biological: Pneumococcal Polysaccharide Vaccine
Single intramuscular injection of pneumococcal polysaccharide vaccine (0.5 mL) on Day 1
Other Name: Pneumovax 23
Active Comparator: Pneumococcal 13-Valent Conjugate Vaccine Biological: Pneumococcal 13-Valent Conjugate Vaccine
Single intramuscular injection of pneumococcal 13-valent conjugate vaccine (0.5 mL) on Day 1
Other Name: Prevnar 13

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01513551     History of Changes
Other Study ID Numbers: V114-002
Study First Received: December 27, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014