Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

NCT ID: NCT01807780

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccination Adverse Events Vaccination Failure Specific Antibody Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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single arm :vaccinated

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

Group Type OTHER

biological monitoring

Intervention Type BIOLOGICAL

Interventions

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biological monitoring

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Military volunteers
* No recently immunized

Exclusion Criteria

* Pregnancy
* Documented immunodepression
* Documented allergy or hypersensitivity to vaccines
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Raffaele D'Amelio

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raffaele D'Amelio, MD

Role: STUDY_CHAIR

sapienza università di roma

Locations

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University of Roma La Sapienza

Roma, Italia, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 30269918 (View on PubMed)

Other Identifiers

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01/2011 UGSAN

Identifier Type: -

Identifier Source: org_study_id

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