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OpenTrials
Completed

NCT Number: NCT01807780

Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Roma La Sapienza

Roma, Italia, 00185, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Military volunteers
  • No recently immunized

Exclusion criteria

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

Treatment and study plan

biological monitoring

Biological

Primary outcomes

  1. immunomediated disorders related to multiple vaccination

    Time frame: three years

Secondary outcomes

  1. efficacy of multiple vaccination

    Time frame: Three years

  2. immunogenicity of multiple vaccination

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 8, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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