CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 152,723 enrolled
Drug / intervention
23-valent pneumococcal vaccine +1 morebiological
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/NCT02079701
NCT02079701Phase 4Completed
CompareCT.gov

Double-Blind Placebo-Controlled Clinical Effectiveness Trial of the 23-Valent Pneumococcal Vaccine Among Military Trainees At Increased Risk of Respiratory Disease

Naval Health Research Center·interventional·Posted Mar 6, 2014·Updated Mar 6, 2014

In Brief

A Phase 4 clinical trial evaluating 23-valent pneumococcal vaccine and Placebo for Pneumonia and Acute Respiratory Disease. Completed, enrolled 152,723 participants across 5 sites.

Detailed Summary

The primary objective is to determine the clinical benefit of employing the 23-valent pneumococcal vaccine among US military trainees. Secondary objectives include: * determining the etiology of clinical pneumonia among U.S. military trainees; * comparing the serotype distribution of S. pneumoniae (Sp) isolates recovered from vaccinated and nonvaccinated trainees diagnosed with pneumonia; and * comparing days lost from training due to pneumonia or acute respiratory disease for vaccinated and nonvaccinated subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Acute Respiratory Disease
CountriesUnited States
CollaboratorsU.S. Army Medical Research and Development Command

Timeline

Phase 4CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2014
Enrollment StartOct 1, 2000
Primary CompletionJun 1, 2003
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.3 years ago

Interventions

23-valent pneumococcal vaccinebiological

randomization, based upon a random-number (block design) double-blind enrollment sequence. 1:1 ratio.

Placebobiological