Completed

Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

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What is being tested

biological monitoring

Biological
Who is being recruted

From 18 to 55 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Roma La Sapienza
Last updated: May 5, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Roma La Sapienza
Last updated: May 5, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

262 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Military volunteers

No recently immunized

3 exclusion criteria prevent from participating
Documented allergy or hypersensitivity to vaccines

Documented immunodepression

Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Roma La Sapienza

Roma, ItalyOpen University of Roma La Sapienza in Google Maps
CompletedOne Study Center