VaricellaPhase 4NCT00830648
Safety of a Second Dose of Biken's Varicella Vaccine
A Phase 4 study testing Live Attenuated Varicella Virus Vaccine in people with Varicella, run by Sanofi Pasteur, a Sanofi Company at 1 site in Argentina.
Trial summary
The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Live Attenuated Varicella Virus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 2009to Dec 2009
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 4 to 6 years on the day of inclusion.
- Informed consent form signed by the parent(s) or legal guardian and by an independent witness.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Written documentation of receipt of a first dose of Varicella Biken vaccine more than 3 months before inclusion.
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination;
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- Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity.
- History of varicella infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against varicella disease with a vaccine different from Varicella Biken vaccine.
- Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina
The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.
All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.
The expected total duration of follow-up (first visit to last visit) for each subject will be one month.
- Conditions
- Varicella
- Being tested
- Live Attenuated Varicella Virus Vaccine
- Keywords
- varicella-zoster virus, varicella
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Varicella Virus VaccineBiological
Also called Varicela Biken
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Live Attenuated Varicella Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety after administration of Varicella vaccine
Measured: one month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830648
- Sponsor's protocol ID
- VBK12
- Status last verified
- Jun 2013
- First submitted
- 27 Jan 2009
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina
- ClinicalTrials.gov ID
- NCT00830648
- Acronym / sponsor ID
- VBK12
- Conditions
- Varicella
- Keywords
- varicella-zoster virus, varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Jan 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 objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.
All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.
The expected total duration of follow-up (first visit to last visit) for each subject will be one month.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Live Attenuated Varicella Virus Vaccine |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 4 to 6 years on the day of inclusion.
- Informed consent form signed by the parent(s) or legal guardian and by an independent witness.
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- Written documentation of receipt of a first dose of Varicella Biken vaccine more than 3 months before inclusion.
Key exclusion criteria (11 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
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 |
|---|---|---|
| Live Attenuated Varicella Virus VaccineAlso: Varicela Biken0.5 mL, Subcutaneous | Biological | 1 |
Primary outcome
To provide information concerning the safety after administration of Varicella vaccine
Time frame: one month after 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 10 Jun 2013.
- 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 Director study director
Sanofi Pasteur Inc.
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 Live Attenuated Varicella Virus Vaccine in people with Varicella, run by Sanofi Pasteur, a Sanofi Company at 1 site in Argentina.
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 11 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 10 Jun 2013. 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 Argentina. 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?
To provide information concerning the safety after administration of Varicella vaccine (time frame: one month after vaccination). 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 10 Jun 2013.