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Completed

NCT Number: NCT01734239

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

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

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumovax™ 23

Biological

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 names: V110

Primary outcomes

  1. Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine

    Time frame: Prevaccination and Day 28 after vaccination

    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays

  2. 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

    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.

  3. Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)

    Time frame: Up to 5 days postvaccination

  4. Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants

    Time frame: Up to Day 14 postvaccination

    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.

  5. Number of Participants Reporting Serious Adverse Experiences

    Time frame: Up to Day 28 postvaccination

    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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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