Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

Phase 4

Completed

• Conditions: Pneumococcal Infection
• Interventions: Biological: PNEUMOVAX™ 23

• Registration Number: NCT02260882
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Study Start: 2014-10-31
• Primary Completion: 2015-04-09
• Study Completion: 2015-04-09
• Results First Submitted: 2016-01-19
• Results First Submitted QC: 2016-01-19
• Results First Posted: 2016-02-17
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Vaccination Group	PNEUMOVAX™ 23	0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination
Revaccination Group	PNEUMOVAX™ 23	0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination	Baseline and 4 weeks after revaccination	Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Adverse Event of Injection-site Erythema	Up to 5 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Injection-site Pain	Up to 5 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Pyrexia	Up to 5 days after vaccination	Percentage of participants with an adverse event of pyrexia (\>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Myalgia	Up to 14 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Arthralgia	Up to 14 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Headache	Up to 14 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination	Baseline and 4 weeks after primary vaccination	Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
Percentage of Participants With an Adverse Event of Injection-site Swelling	Up to 5 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.
Percentage of Participants With an Adverse Event of Fatigue	Up to 14 days after vaccination	An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.