NCT02079701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152,723

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

2.7 years

First QC Date

March 3, 2014

Last Update Submit

March 5, 2014

Conditions

PneumoniaAcute Respiratory Disease

Keywords

pneumoniapneumococcusvaccine23-valent pneumococcal vaccinemilitary recruits

Outcome Measures

Primary Outcomes (2)

  • Radiologically confirmed all-cause pneumonia

    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.

    During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization

  • Acute respiratory disease

    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.

    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

Secondary Outcomes (3)

  • Etiology of radiographically-confirmed pneumonias

    During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization

  • Serotype distribution of S. pneumoniae isolates recovered from participants with pneumonia

    During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization

  • Days lost from recruit training

    During the 12 weeks (Marines), 8 weeks (Navy), and 9 weeks (Army) period while in recruit training after immunization

Study Arms (2)

23-valent pneumococcal vaccine

EXPERIMENTAL

single dose, 23-valent pneumococcal vaccine, 0.5ml, intramuscular (IM)

Biological: 23-valent pneumococcal vaccine

placebo

PLACEBO COMPARATOR

0.5 ml injectible saline, IM

Biological: Placebo

Interventions

23-valent pneumococcal vaccineBIOLOGICAL

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

Also known as: Pnu-Imune, Pneumovax 23
23-valent pneumococcal vaccine
PlaceboBIOLOGICAL
placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Marine Recruit Training Center

San Diego, California, United States

Location

Naval Recruit Training Center

Great Lakes, Illinois, United States

Location

Army Recruit Training Center

Fort Leonard Wood, Missouri, United States

Location

Army Recruit Training Center

Fort Jackson, South Carolina, United States

Location

Marine Recruit Training Center

Parris Island, South Carolina, United States

Location

Related Publications (6)

  • Plouffe JF, Breiman RF, Facklam RR. Bacteremia with Streptococcus pneumoniae. Implications for therapy and prevention. Franklin County Pneumonia Study Group. JAMA. 1996 Jan 17;275(3):194-8. doi: 10.1001/jama.275.3.194.

    PMID: 8604171BACKGROUND

  • Gray GC, Mitchell BS, Tueller JE, Cross ER, Amundson DE. Pneumonia hospitalizations in the US Navy and Marine Corps: rates and risk factors for 6,522 admissions, 1981-1991. Am J Epidemiol. 1994 Apr 15;139(8):793-802. doi: 10.1093/oxfordjournals.aje.a117076.

    PMID: 8178792BACKGROUND

  • McMillan A, Pattman RS. Evaluation of urethral culture for Neisseria gonorrhoeae in the routine investigation of men attending a STD clinic. Br J Vener Dis. 1979 Aug;55(4):271-3. doi: 10.1136/sti.55.4.271.

    PMID: 114197BACKGROUND

  • Gray GC, Callahan JD, Hawksworth AW, Fisher CA, Gaydos JC. Respiratory diseases among U.S. military personnel: countering emerging threats. Emerg Infect Dis. 1999 May-Jun;5(3):379-85. doi: 10.3201/eid0503.990308.

    PMID: 10341174BACKGROUND

  • Fine MJ, Smith MA, Carson CA, Meffe F, Sankey SS, Weissfeld LA, Detsky AS, Kapoor WN. Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials. Arch Intern Med. 1994 Dec 12-26;154(23):2666-77. doi: 10.1001/archinte.1994.00420230051007.

    PMID: 7993150BACKGROUND

  • Russell KL, Baker CI, Hansen C, Poland GA, Ryan MA, Merrill MM, Gray GC. Lack of effectiveness of the 23-valent polysaccharide pneumococcal vaccine in reducing all-cause pneumonias among healthy young military recruits: a randomized, double-blind, placebo-controlled trial. Vaccine. 2015 Feb 25;33(9):1182-7. doi: 10.1016/j.vaccine.2014.12.058. Epub 2015 Jan 8.

    PMID: 25579777DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

23-valent pneumococcal capsular polysaccharide vaccinePneumococcal Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Kevin L Russell, MD, MTM&H

    Naval Health Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Respiratory Disease Laboratory (at that time)

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 6, 2014

Study Start

October 1, 2000

Primary Completion

June 1, 2003

Study Completion

June 1, 2007

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

US(5)