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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734239
• Other study ID #: V110-018
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2013
• Est. completion date: October 22, 2013

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 22, 2013
• Est. primary completion date: October 22, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. Epub 2016 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine	Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays	Prevaccination and Day 28 after vaccination
Primary	Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine	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.	Day 28 postvaccination
Primary	Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)		Up to 5 days postvaccination
Primary	Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants	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.	Up to Day 14 postvaccination
Primary	Number of Participants Reporting Serious Adverse Experiences	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	Up to Day 28 postvaccination