SmallpoxNCT00998543
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
An observational study of Smallpox, run by Sanofi at 5 sites in France.
Trial summary
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947). Read more about this study
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)
Who may be able to join
- Subject vaccinated and who completed the Phase II VVL04 trial.
- Informed consent form signed.
- Subject able to comply with all trial procedures.
- Subject entitled to national social security.
Who cannot join
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Study site
Gières, 38610
Study site
Lagord, 17140
Study site
Montpellier, 34094
Study site
Paris, 75015
Study site
Poitiers, 86000
About this study
Official title: A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
Primary Objectives:
Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.
Safety: To follow-up the long-term safety up to 5 years post-vaccination.
Read the detailed description
None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).
- Conditions
- Smallpox
- Keywords
- Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smallpox Vaccine (LISTER Strain) Group | Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
Measured: 1 to 5 years post-vaccination
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
Measured: 1 to 5 years post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2006
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998543
- Sponsor's protocol ID
- VVL05
- Status last verified
- Aug 2012
- First submitted
- 19 Oct 2009
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
- ClinicalTrials.gov ID
- NCT00998543
- Acronym / sponsor ID
- VVL05
- Conditions
- Smallpox
- Keywords
- Smallpox Vaccinia Virus Smallpox Vaccine Variola Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Oct 2009 (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 provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
Primary Objectives:
Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.
Safety: To follow-up the long-term safety up to 5 years post-vaccination.
Detailed description
None of the participants in this study will receive any vaccination as part of the study. All participants will provide blood samples for immunogenicity testing at the 1, 2, 3, 4, and 5 year anniversaries of vaccination. Safety will be assessed for up to 5 years after vaccination, including follow-up of reactions that occurred during Study VVL04 (NCT 00258947).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smallpox Vaccine (LISTER Strain) Group | – | –Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947)
Key inclusion criteria (4 listed)
- Subject vaccinated and who completed the Phase II VVL04 trial.
- Informed consent form signed.
- Subject able to comply with all trial procedures.
- Subject entitled to national social security.
Key exclusion criteria (1 listed)
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination.
Time frame: 1 to 5 years post-vaccination
To provide information concerning the safety after primary administration of live vaccinia virus (LISTER strain).
Time frame: 1 to 5 years post-vaccination
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 6 Aug 2012.
- Related InfoLink provided by the sponsor.
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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.
Medical Monitor study director
Sanofi Pasteur Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smallpox, run by Sanofi at 5 sites in France.
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 4 inclusion and 1 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 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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.
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?
To provide information concerning the immune response of live vaccinia virus (LISTER strain) after primary vaccination. (time frame: 1 to 5 years post-vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2012.