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Effectiveness of the Pneumococcal Polysaccharide Vaccine in Military Recruits

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ClinicalTrials.gov Identifier: NCT02079701
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Kevin Russell, Naval Health Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pneumonia Acute Respiratory Disease Biological: 23-valent pneumococcal vaccine Biological: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152723 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Clinical Effectiveness Trial of the 23-Valent Pneumococcal Vaccine Among Military Trainees At Increased Risk of Respiratory Disease
Study Start Date : October 2000
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 23-valent pneumococcal vaccine
single dose, 23-valent pneumococcal vaccine, 0.5ml, intramuscular (IM)
Biological: 23-valent pneumococcal vaccine
randomization, based upon a random-number (block design) double-blind enrollment sequence. 1:1 ratio.
Other Names:
  • Pnu-Imune
  • Pneumovax 23

Placebo Comparator: placebo
0.5 ml injectible saline, IM
Biological: Placebo



Primary Outcome Measures :
  1. Radiologically confirmed all-cause pneumonia [ Time Frame: During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization ]
    During the active surveillance period while participants are still in recruit training(variable time frame depending on which Service), study participants with suspect pneumonia were identified by the attending physician. Study staff followed up on the results of chest xray to identify all radiographically-confirmed pneumonia cases.

  2. Acute respiratory disease [ Time Frame: Participants will be followed as long on active duty, up to June 2007, which is up to 6.7 years, depending upon when they entered the study ]
    Passive electronic monitoring of health care encounters for outcomes other than recruit training clinical and radiographically-confirmed pneumonia took place during recruit training and at the subsequent duty stations using the DoD comprehensive electronic databases of outpatient healthcare encounters (SADR), inpatient encounters (SIDR), and encounters at civilian facilities billed to the DoD (HCSR). ICD-9-CM codes 480 through -486 and 487 were monitored for these outcomes throughout the entire study period.


Secondary Outcome Measures :
  1. Etiology of radiographically-confirmed pneumonias [ Time Frame: During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization ]
    During the active surveillance period while participants are still in recruit training(variable time frame depending on which Service), those with radiographically-confirmed pneumonia will be sampled for etiologic agent as comprehensively described in the study design section.

  2. Serotype distribution of S. pneumoniae isolates recovered from participants with pneumonia [ Time Frame: During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization ]
    During the active surveillance period while participants are still in recruit training(variable time frame depending on which Service), those with radiographically-confirmed pneumonia will be sampled for etiologic agent and any S.p. isolates identified to serotype as comprehensively described in the study design section.

  3. Days lost from recruit training [ Time Frame: During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization ]
    During the active surveillance period while participants are still in recruit training(variable time frame depending on which Service), participants will be monitored for days lost from training as comprehensively described in the study design section.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • basic training recruits at 5 recruit training centers (in South Carolina, Missouri, Illinois, and California) were invited to participate during their first week of training from Oct 2000 through Jun 2003

Exclusion Criteria:

  • positive pregnancy results
  • having previously received the a 23-valent pneumococcal vaccine during the previous 5 years or
  • having a medical condition that either required or precluded pneumococcal vaccination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079701


Locations
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United States, California
Marine Recruit Training Center
San Diego, California, United States
United States, Illinois
Naval Recruit Training Center
Great Lakes, Illinois, United States
United States, Missouri
Army Recruit Training Center
Ft. Leonard Wood, Missouri, United States
United States, South Carolina
Army Recruit Training Center
Ft. Jackson, South Carolina, United States
Marine Recruit Training Center
Parris Island, South Carolina, United States
Sponsors and Collaborators
Naval Health Research Center
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Kevin L Russell, MD, MTM&H Naval Health Research Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kevin Russell, Director, Respiratory Disease Laboratory (at that time), Naval Health Research Center
ClinicalTrials.gov Identifier: NCT02079701     History of Changes
Other Study ID Numbers: DAMD17-00-2-0013
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014
Keywords provided by Kevin Russell, Naval Health Research Center:
pneumonia
pneumococcus
vaccine
23-valent pneumococcal vaccine
military recruits
Additional relevant MeSH terms:
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Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs