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

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ClinicalTrials.gov Identifier: NCT01513551
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01513551     History of Changes
Other Study ID Numbers: V114-002
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015

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