VaricellaPhase 4NCT00432731
Safety Study of a Refrigerator-stable Formulation of VARIVAX®
A Phase 4 study testing VARIVAX® and M-M-RTM II in people with Varicella and Measles, run by Merck Sharp & Dohme LLC at 25 sites in 2 countries.
Trial summary
Primary objective: To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination. Secondary objectives: NA Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- What is being tested?
- VARIVAX® and M-M-RTM II
- How many people
- 500 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Dec 2004to Sep 2005
- 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 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants from 12 months of age to 15 months of age.
- Consent form signed by both parents or by the legal representative(s), properly informed about the study,
- Parent(s) able to understand the protocol requirements and to fill in the Diary Card.
Who cannot join
- Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- Any known recent (≤30 days) exposure to measles, mumps or rubella,
- Any known recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
- Active untreated tuberculosis,
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- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
- Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
- Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
France24 sites
Study site
Amboise
Study site
Ancenis
Study site
Betton
Study site
Châteaubriant
Study site
Courbevoie
Study site
Essey-lès-Nancy
Study site
Floirac
Study site
Fougères
Study site
Garches
Study site
Gradignan
Study site
Issy-les-Moulineaux
Study site
Joué-les-Tours
Study site
Libourne
Study site
Lingolsheim
Study site
Mérignac
Study site
Nancy
Study site
Paris
Study site
Rueil-Malmaison
Study site
Strasbourg
Study site
Suresnes
Study site
Tours
Study site
Tresses
Study site
Vandœuvre-lès-Nancy
Study site
Villers-lès-Nancy
About this study
Official title: A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
Primary objective:
To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.
Secondary objectives: NA
- Being tested
- VARIVAX®, M-M-RTM II
- Keywords
- Prevention of : Varicella, Measles, Mumps, Rubella
- Medical subject headings
- Chickenpox, Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIVAX®Biological
M-M-RTM IIBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startDec 2004
- Primary completionSep 2005
- Study completionSep 2005
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 VaricellaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne FIQUET, MD, Study director, SPMSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432731
- Sponsor's protocol ID
- V210-061
- Other IDs
- X04-VAR-402
- Status last verified
- Mar 2017
- First submitted
- 7 Feb 2007
- Last updated
- 14 Mar 2017
- Results posted
- No
Publications
Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. doi: 10.4161/hv.8269. Epub 2009 Jul 23.
PubMed 19305145
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
- ClinicalTrials.gov ID
- NCT00432731
- Acronym / sponsor ID
- V210-061
- Keywords
- Prevention of : Varicella, Measles, Mumps, Rubella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 8 Feb 2007 (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.
Primary objective:
To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.
Secondary objectives: NA
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants from 12 months of age to 15 months of age.
- Consent form signed by both parents or by the legal representative(s), properly informed about the study,
- Parent(s) able to understand the protocol requirements and to fill in the Diary Card.
Key exclusion criteria (10 listed)
- Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- Any known recent (≤30 days) exposure to measles, mumps or rubella,
- Any known recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
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 |
|---|---|---|
| VARIVAX® | Biological | – |
| M-M-RTM II | Biological | – |
Primary outcome
Not reported in the source record.
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 14 Mar 2017.
- Derived from this study: PubMed 19305145Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. doi: 10.4161/hv.8269. Epub 2009 Jul 23.
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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.
Anne FIQUET, MD study director
SPMSD
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VARIVAX® and M-M-RTM II in people with Varicella and Measles, run by Merck Sharp & Dohme LLC at 25 sites in 2 countries.
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 3 inclusion and 10 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France, 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432731, 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 14 Mar 2017.