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A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01734239
First received: November 21, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease


Condition Intervention Phase
Pneumococcal Disease
Biological: Pneumovax™ 23
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, From the Russian Population

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine [ Time Frame: Prevaccination and Day 28 after vaccination ] [ Designated as safety issue: No ]
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays

  • Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine [ Time Frame: Day 28 postvaccination ] [ Designated as safety issue: No ]
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.

  • Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) [ Time Frame: Up to 5 days postvaccination ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants [ Time Frame: Up to Day 14 postvaccination ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.

  • Number of Participants Reporting Serious Adverse Experiences [ Time Frame: Up to Day 28 postvaccination ] [ Designated as safety issue: Yes ]
    A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention


Enrollment: 102
Study Start Date: June 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumovax™ 23: Participants Between 2 and 49 Years
Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
Biological: Pneumovax™ 23
Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
Other Name: V110
Experimental: Pneumovax™ 23: Participants >=50 Years
Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
Biological: Pneumovax™ 23
Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
Other Name: V110

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For participants 50 years of age or older: any underlying chronic illness must be in stable condition
  • For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
  • Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

Exclusion Criteria:

  • Received prior vaccination with pneumococcal vaccine
  • Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
  • Has history of autoimmune disease
  • Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
  • Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
  • Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)
  • Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
  • Hospitalized for acute illness within 3 months before study vaccination
  • Is a pregnant woman or nursing mother
  • History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
  • History of fever illness within 3 days before study vaccination
  • Received antibiotic therapy for any acute illness within 7 days before study vaccination
  • Hypersensitivity to any components of the vaccine, including phenol
  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: NCT01734239

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01734239     History of Changes
Other Study ID Numbers: V110-018
Study First Received: November 21, 2012
Results First Received: August 26, 2014
Last Updated: August 26, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health

ClinicalTrials.gov processed this record on November 20, 2014