Clinical trial NCT02260882: Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Official title: A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 243
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.


Eligibility criteria: Inclusion Criteria:

* Japanese participant
* Good health or any underlying chronic illness is documented to be in stable condition
* Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
* Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria:
* Known allergy or sensitivity to any of the components of the study vaccine
* History of pneumococcal conjugate vaccination
* Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
* Functional or anatomic asplenia
* Received immunoglobulin within 6 months before study vaccine or is planned during the study
* Received any investigational drugs or vaccines within 2 months before study vaccination
* History of pneumococcal disease (positive culture from blood or other normally sterile site)
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* History of convulsion
* Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
* Participating in any other clinical trial

Primary outcomes:
measure: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
timeFrame: Baseline and 4 weeks after revaccination
Secondary outcomes:
measure: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
timeFrame: Baseline and 4 weeks after primary vaccination
measure: Percentage of Participants With an Adverse Event of Injection-site Erythema
timeFrame: Up to 5 days after vaccination
measure: Percentage of Participants With an Adverse Event of Injection-site Swelling
timeFrame: Up to 5 days after vaccination
measure: Percentage of Participants With an Adverse Event of Injection-site Pain
timeFrame: Up to 5 days after vaccination
measure: Percentage of Participants With an Adverse Event of Pyrexia
timeFrame: Up to 5 days after vaccination
measure: Percentage of Participants With an Adverse Event of Myalgia
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With an Adverse Event of Arthralgia
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With an Adverse Event of Headache
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With an Adverse Event of Fatigue
timeFrame: Up to 14 days after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.