Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Vaccination Failure; Specific Antibody Response; Vaccination Adverse Events

Treatments: Biological: biological monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01807780

01/2011 UGSAN

Details and patient eligibility

About

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.

Enrollment: 262 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Military volunteers
• No recently immunized

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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262 participants in 1 patient group

single arm :vaccinated

Other group

Description:

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

Treatment:

Biological: biological monitoring