- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807780
Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
May 2, 2017 updated by: Raffaele D'Amelio, University of Roma La Sapienza
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
262
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Italia
-
Roma, Italia, Italy, 00185
- University of Roma La Sapienza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Military volunteers
- No recently immunized
Exclusion Criteria:
- Pregnancy
- Documented immunodepression
- Documented allergy or hypersensitivity to vaccines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: single arm :vaccinated
military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immunomediated disorders related to multiple vaccination
Time Frame: three years
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
efficacy of multiple vaccination
Time Frame: Three years
|
Three years
|
immunogenicity of multiple vaccination
Time Frame: Three years
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Raffaele D'Amelio, MD, Sapienza Università di Roma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
March 6, 2013
First Posted (Estimate)
March 8, 2013
Study Record Updates
Last Update Posted (Actual)
May 5, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 01/2011 UGSAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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