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

Merck Sharp & Dohme LLC243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

243

Conditions

Pneumococcal Infection

Interventions

PNEUMOVAX™ 23BIOLOGICAL

PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)

Eligibility

Sex: ALLMin age: 70 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 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.

Time frame: Baseline and 4 weeks after revaccination

Secondary Outcomes

Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination

Time frame: Baseline and 4 weeks after primary vaccination

Percentage of Participants With an Adverse Event of Injection-site Erythema

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.

Time frame: Up to 5 days after vaccination

Percentage of Participants With an Adverse Event of Injection-site Swelling

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Up to 5 days after vaccination

Percentage of Participants With an Adverse Event of Injection-site Pain

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.

Time frame: Up to 5 days after vaccination

Percentage of Participants With an Adverse Event of Pyrexia

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.

Time frame: Up to 5 days after vaccination

Percentage of Participants With an Adverse Event of Myalgia

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.

Time frame: Up to 14 days after vaccination

Percentage of Participants With an Adverse Event of Arthralgia

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.

Time frame: Up to 14 days after vaccination

Percentage of Participants With an Adverse Event of Headache

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.

Time frame: Up to 14 days after vaccination

Percentage of Participants With an Adverse Event of Fatigue

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.

Time frame: Up to 14 days after vaccination