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CompletedNCT01807780Updated May 5, 2017

Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

A Phase 4 interventional study of biological monitoring in Vaccination Adverse Events, Vaccination Failure and Specific Antibody Response, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-05.

Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
262
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
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Study 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.

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Conditions studied

  • Vaccination Adverse Events
  • Vaccination Failure
  • Specific Antibody Response
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In context

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Military volunteers
  • No recently immunized

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Documented immunodepression
  • Documented allergy or hypersensitivity to vaccines
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
262 participants (actual)

Study arms

  • Other
    single arm :vaccinated

    military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy

    Biological: biological monitoring

Interventions

  • Biologicalbiological monitoring
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What researchers measure

Primary outcomes

  1. immunomediated disorders related to multiple vaccination

    Time frame: three years

Secondary outcomes

  1. efficacy of multiple vaccination

    Time frame: Three years

  2. immunogenicity of multiple vaccination

    Time frame: Three years

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Study locations

1 site
  • University of Roma La Sapienza
    Roma, Italia 00185, Italy
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References and documents

Publications

  • 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. PubMed 30269918 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01807780
Lead sponsor
University of Roma La Sapienza
Responsible party
Raffaele D'Amelio (Full Professor, University of Roma La Sapienza) — Principal investigator
First posted
Mar 8, 2013
Start date
Sep 2012
Primary completion
Dec 2014
Completion
Sep 2015
Last update
May 5, 2017

Study contacts

Raffaele D'Amelio, MD
study chair · sapienza università di roma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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