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. - Russian Registration Study of PPV23

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites102 target enrollmentApril 21, 2015

ConditionsVaccination against pneumococcal disease caused by the 23 serotypes included in the vaccine Therapeutic area: Body processes [G] - Immune system processes [G12]

DrugsPNEUMOVAX 23

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vaccination against pneumococcal disease caused by the 23 serotypes included in the vaccine
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 102
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 21, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•All subjects must be from the Russian population.
•a. Subjects 50 years of age or older. Any underlying chronic illness must be documented to be in stable condition.
•b. Subjects 2 to 49 years of age with an increased risk for pneumococcal disease as a result of one of the following conditions:
•Chronic cardiovascular disease (including congestive heart failure and cardiomyopathies)
•Chronic pulmonary disease (including chronic obstructive pulmonary disease \& emphysema)
•Diabetes mellitus
•Alcoholism
•Chronic liver disease (including cirrhosis)
•Cerebrospinal fluid leaks
•Functional or anatomic asplenia

Exclusion Criteria

•a. Hypersensitivity to any of the components of the study vaccine, including phenol. See Attachments for PNEUMOVAX™ 23 Package Labeling.
•b. Prior vaccination with any pneumococcal polysaccharide or conjugate vaccine. When available, written medical records should be reviewed to verify the subject’s denial of receiving a prior pneumococcal vaccination.
•c. Known or suspected immune dysfunction, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record \=3mg/dL), or other conditions associated with immunosuppression such as organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy, including long\-term systemic corticosteroids. (Subjects with prostate, breast, or skin cancer who are not on chemotherapeutic drugs \[other than hormone blocking drugs] and subjects with other malignancies who have been disease\-free for at least 5 years will be eligible for enrollment).
•d. History of autoimmune disease
•e. Receipt of other licensed vaccines during the study period as follows:
•Licensed live virus vaccines received during the 3 months prior to injection with the study vaccine or scheduled within 3 months after receipt of the study vaccine.
•Inactivated licensed vaccines received during the 28 days prior to injection with the study vaccine or scheduled prior to the Day 28 postvaccination visit.
•f. Receipt of investigational drugs or other investigational vaccines within 2 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final (Day 28\) postvaccination visit (3 months if a live virus vaccine).
•g. Receipt of any blood product or immunoglobulin preparation within the 6 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final (Day 28\) postvaccination visit.
•h. Recent hospitalization for acute illness within the 3 months before receipt of the study vaccine.