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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Disease

Treatments

Biological: Pneumovax™ 23

Study type

Interventional

Funder types

Industry

Identifiers

NCT01734239

V110-018

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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