CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 764 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +1 morebiological
Likely dose
13-valent pneumococcal conjugate vaccine 0.5 mLfrom 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/NCT01646398
NCT01646398Phase 3Completed

A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

Pfizer·interventional·Posted Jul 20, 2012·Updated Sep 20, 2013

In Brief

A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for Pneumococcal Vaccines and Pneumococcal Conjugate Vaccine. Completed, enrolled 764 participants across 8 sites.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2012
Enrollment StartJun 1, 2012
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.0 years ago

Interventions

13-valent pneumococcal conjugate vaccinebiological

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

23-valent pneumococcal polysaccharide vaccinebiological

A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.