Clinical trial NCT01734239: A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 102
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
timeFrame: Prevaccination and Day 28 after vaccination
measure: Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
timeFrame: Day 28 postvaccination
measure: Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
timeFrame: Up to 5 days postvaccination
measure: Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
timeFrame: Up to Day 14 postvaccination
measure: Number of Participants Reporting Serious Adverse Experiences
timeFrame: Up to Day 28 postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.