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

NCT ID: NCT02260882

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-04-09

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.

Conditions

Pneumococcal Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Revaccination Group

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

Group Type: EXPERIMENTAL

PNEUMOVAX™ 23

Intervention Type: BIOLOGICAL

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

Primary Vaccination Group

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

Group Type: EXPERIMENTAL

PNEUMOVAX™ 23

Intervention Type: BIOLOGICAL

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

Interventions

PNEUMOVAX™ 23

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

Intervention Type: BIOLOGICAL

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

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 27265450 (View on PubMed)

Other Identifiers

152859

Identifier Type: REGISTRY

Identifier Source: secondary_id

V110-902

Identifier Type: -

Identifier Source: org_study_id