Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

• Sponsor: University of Roma La Sapienza (Other)
• Overall Status: Completed
• CT.gov ID: NCT01807780
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Adverse Events; Vaccination Failure; Specific Antibody Response	Biological: biological monitoring	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: single arm :vaccinated military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy	Biological: biological monitoring

Outcome Measures

Primary Outcome Measures

1. immunomediated disorders related to multiple vaccination [three years]

Secondary Outcome Measures

1. efficacy of multiple vaccination [Three years]

2. immunogenicity of multiple vaccination [Three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Military volunteers

• No recently immunized

Exclusion Criteria:

• Pregnancy

• Documented immunodepression

• Documented allergy or hypersensitivity to vaccines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Roma La Sapienza	Roma	Italia	Italy	00185

Sponsors and Collaborators

• University of Roma La Sapienza

Investigators

• Study Chair: Raffaele D'Amelio, MD, sapienza università di roma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raffaele D'Amelio, Full Professor, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT01807780
• Other Study ID Numbers: 01/2011 UGSAN
• First Posted: Mar 8, 2013
• Last Update Posted: May 5, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of May 5, 2017