Vaccination Adverse EventsPhase 4NCT01807780
Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
A Phase 4 study testing biological monitoring in people with Vaccination Adverse Events and Vaccination Failure, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination Adverse Events, Vaccination Failure, Specific Antibody Response
- What is being tested?
- biological monitoring
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Military volunteers
- No recently immunized
Who cannot join
- Pregnancy
- Documented immunodepression
- Documented allergy or hypersensitivity to vaccines
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- biological monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological monitoringBiological
| Study group | Role | What they receive |
|---|---|---|
| single arm :vaccinated | Other | military personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy Receives: Biological: biological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunomediated disorders related to multiple vaccination
Measured: three years
Secondary outcomes (2)
efficacy of multiple vaccination
Measured: Three years
immunogenicity of multiple vaccination
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination Adverse EventsStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele D'Amelio, University of Roma La Sapienza
- Investigators
- Raffaele D'Amelio, MD, Study chair, sapienza università di roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807780
- Sponsor's protocol ID
- 01/2011 UGSAN
- Status last verified
- May 2017
- First submitted
- 13 Dec 2012
- Last updated
- 5 May 2017
- Results posted
- No
- Individual data sharing
- No
Publications
Ferlito C, Biselli R, Mariotti S, von Hunolstein C, Teloni R, Ralli L, Pinto A, Pisani G, Tirelli V, Biondo MI, Salerno G, Andreasi Bassi L, Lulli P, Autore A, Scagliusi A, Tomao E, Germano V, Picchianti Diamanti A, Caporuscio S, Milanetti F, Salemi S, Nisini R, D'Amelio R. Tetanus-diphtheria vaccination in adults: the long-term persistence of antibodies is not dependent on polyclonal B-cell activation and the defective response to diphtheria toxoid re-vaccination is associated to HLADRB1 *01. Vaccine. 2018 Oct 29;36(45):6718-6725. doi: 10.1016/j.vaccine.2018.09.041. Epub 2018 Sep 27.
PubMed 30269918
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
- ClinicalTrials.gov ID
- NCT01807780
- Acronym / sponsor ID
- 01/2011 UGSAN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm :vaccinated | Other | Biological: biological monitoringmilitary personnel vaccinated with multiple vaccines and monitored about safety, immunogenicity and efficacy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Military volunteers
- No recently immunized
Key exclusion criteria (3 listed)
- Pregnancy
- Documented immunodepression
- Documented allergy or hypersensitivity to vaccines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological monitoring | Biological | single arm :vaccinated |
Primary outcome
immunomediated disorders related to multiple vaccination
Time frame: three years
2 secondary outcomes
efficacy of multiple vaccination
Time frame: Three years
immunogenicity of multiple vaccination
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 30269918Ferlito C, Biselli R, Mariotti S, von Hunolstein C, Teloni R, Ralli L, Pinto A, Pisani G, Tirelli V, Biondo MI, Salerno G, Andreasi Bassi L, Lulli P, Autore A, Scagliusi A, Tomao E, Germano V, Picchianti Diamanti A, Caporuscio S, Milanetti F, Salemi S, Nisini R, D'Amelio R. Tetanus-diphtheria vaccination in adults: the long-term persistence of antibodies is not dependent on polyclonal B-cell activation and the defective response to diphtheria toxoid re-vaccination is associated to HLADRB1 *01. Vaccine. 2018 Oct 29;36(45):6718-6725. doi: 10.1016/j.vaccine.2018.09.041. Epub 2018 Sep 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele D'Amelio, MD study chair
sapienza università di roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biological monitoring in people with Vaccination Adverse Events and Vaccination Failure, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunomediated disorders related to multiple vaccination (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.