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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination [ Time Frame: Baseline and 4 weeks after revaccination ]

Original Primary Outcome: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination [ Time Frame: Baseline and 4 weeks after revaccination ]

Current Secondary Outcome:

• 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 ]
  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 Erythema [ Time Frame: 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 Swelling [ Time Frame: 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 Injection-site Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
• Percentage of Participants With an Adverse Event of Fatigue [ Time Frame: Up to 14 days after vaccination ]
• Change from Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Initial Vaccination [ Time Frame: Baseline and 4 weeks after primary vaccination ]
• Percentage of Participants with Adverse Experience (AE) of Injection-site Redness [ Time Frame: Up to 5 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Injection-site Swelling [ Time Frame: Up to 5 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Injection-site Pain or Tenderness [ Time Frame: Up to 5 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Elevated Temperature (>=37.5°C, oral) [ Time Frame: Up to 5 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Muscle Pain [ Time Frame: Up to 14 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Joint Pain [ Time Frame: Up to 14 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Headache [ Time Frame: Up to 14 days after revaccination or primary vaccination ]
• Percentage of Participants with AE of Tiredness [ Time Frame: Up to 14 days after revaccination or primary vaccination ]

Dates:
Date Received: October 6, 2014
Date Started: October 2014
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017