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

Pneumococcal Infection Clinical Trial

Official title:

A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260882
• Other study ID #: V110-902
• Secondary ID: 152859
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2014
• Est. completion date: April 9, 2015

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 9, 2015
• Est. primary completion date: April 9, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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):38 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 weeks after revaccination
Secondary	Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 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.	Baseline and 4 weeks after primary vaccination
Secondary	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.	Up to 5 days after vaccination
Secondary	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.	Up to 5 days after vaccination
Secondary	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.	Up to 5 days after vaccination
Secondary	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.	Up to 5 days after vaccination
Secondary	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.	Up to 14 days after vaccination
Secondary	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.	Up to 14 days after vaccination
Secondary	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.	Up to 14 days after vaccination
Secondary	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.	Up to 14 days after vaccination