Overview

This trial is active, not recruiting.

Conditions vaccination adverse events, vaccination efficacy, vaccination immunogenicity
Treatment biological monitoring
Phase phase 4
Sponsor University of Roma La Sapienza
Start date September 2012
End date December 2014
Trial size 310 participants
Trial identifier NCT01807780, 01/2011 UGSAN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy
biological monitoring

Primary Outcomes

Measure
immunomediated disorders related to multiple vaccination
time frame: three years
immunogenicity of multiple vaccination
time frame: Three years

Secondary Outcomes

Measure
efficacy of multiple vaccination
time frame: Three years

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Military volunteers - No recently immunized Exclusion Criteria: - Pregnancy - Documented immunodepression - Documented allergy or hypersensitivity to vaccines

Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.