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Effectiveness of the Pneumococcal Polysaccharide Vaccine in Military Recruits

NCT02079701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152723

Last updated 2014-03-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

23-valent pneumococcal vaccine

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

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Naval Health Research Center

    lead FED

Principal Investigators

  • Kevin L Russell, MD, MTM&H · Naval Health Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2003-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079701 on ClinicalTrials.gov