CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 243 enrolled
Drug / intervention
PNEUMOVAX™ 23biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02260882
NCT02260882Phase 4Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Oct 9, 2014·Updated Oct 30, 2018

In Brief

A Phase 4 clinical trial evaluating PNEUMOVAX™ 23 for Pneumococcal Infection. Completed, enrolled 243 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infection
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2014
Enrollment StartOct 31, 2014
Primary CompletionApr 9, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.7 years ago

Interventions

PNEUMOVAX™ 23biological

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