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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-03

Study Completion Date

2013-10-22

Brief Summary

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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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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pneumovax™ 23: Participants Between 2 and 49 Years

Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

Group Type EXPERIMENTAL

Pneumovax™ 23

Intervention Type 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

Pneumovax™ 23: Participants >=50 Years

Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

Group Type EXPERIMENTAL

Pneumovax™ 23

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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V110

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes