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

NCT02260882 | Completed Phase 4 Results

• 2 other identifiers: V110-902152859
• Study Type: interventional
• Target: 243
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  Baseline and 4 weeks after primary vaccination

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

  Up to 5 days after vaccination

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

  Up to 5 days after vaccination

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

  Up to 5 days after vaccination

• Percentage of Participants With an Adverse Event of Pyrexia

  Up to 5 days after vaccination

Study Arms (2)

Revaccination Group

EXPERIMENTAL

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

Biological: PNEUMOVAX™ 23

Primary Vaccination Group

EXPERIMENTAL

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

Biological: PNEUMOVAX™ 23

Interventions

PNEUMOVAX™ 23 BIOLOGICAL

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

Primary Vaccination Group; Revaccination Group

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.

  PMID: 27265450 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: October 31, 2014
• Primary Completion: April 9, 2015
• Study Completion: April 9, 2015
• Last Updated: October 30, 2018
• Results First Posted: February 17, 2016

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share