Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
1 other identifier
interventional
262
1 country
1
Brief Summary
The purpose of this study is to determine if multiple vaccination in military personnel may be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome, autoimmune or lymphoproliferative disorders. At the same time, considering possible interference between different vaccines, proteins and polysaccharides, living and inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the specific Human Leucocyte Antigens (HLA) genetic structure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2012
Typical duration for phase_4
1 active site
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
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMay 5, 2017
May 1, 2017
2.2 years
December 13, 2012
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
immunomediated disorders related to multiple vaccination
three years
Secondary Outcomes (2)
efficacy of multiple vaccination
Three years
immunogenicity of multiple vaccination
Three years
Study Arms (1)
single arm :vaccinated
OTHERmilitary personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy
Interventions
Eligibility Criteria
You may qualify if:
- Military volunteers
- No recently immunized
You may not qualify if:
- Pregnancy
- Documented immunodepression
- Documented allergy or hypersensitivity to vaccines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Roma La Sapienza
Roma, Italia, 00185, Italy
Related Publications (1)
Ferlito C, Biselli R, Mariotti S, von Hunolstein C, Teloni R, Ralli L, Pinto A, Pisani G, Tirelli V, Biondo MI, Salerno G, Andreasi Bassi L, Lulli P, Autore A, Scagliusi A, Tomao E, Germano V, Picchianti Diamanti A, Caporuscio S, Milanetti F, Salemi S, Nisini R, D'Amelio R. Tetanus-diphtheria vaccination in adults: the long-term persistence of antibodies is not dependent on polyclonal B-cell activation and the defective response to diphtheria toxoid re-vaccination is associated to HLADRB1 *01. Vaccine. 2018 Oct 29;36(45):6718-6725. doi: 10.1016/j.vaccine.2018.09.041. Epub 2018 Sep 27.
PMID: 30269918DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Raffaele D'Amelio, MD
sapienza università di roma
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
December 13, 2012
First Posted
March 8, 2013
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Study Completion
September 1, 2015
Last Updated
May 5, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share