MeaslesPhase 3NCT00432523
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
A Phase 3 study testing M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® in people with Measles and Mumps, run by Merck Sharp & Dohme LLC at 2 sites in 2 countries.
Trial summary
Primary objective: To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and… Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- What is being tested?
- M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
- How many people
- 752 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jan 2005to 5 Sep 2005
- Phase
- Phase 3
- 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 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy subject of either gender,
- Age 12 to 18 months ,
- Consent form signed by both parent(s) or by the legal representative properly informed about the study,
- Parent(s) / legal representative 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 recent (≤30 days) exposure to measles, mumps or rubella,
- Any recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness
- Any severe chronic disease,
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- Active untreated tuberculosis,
- Known personal history of seizures,
- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
- Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
- Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
- Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age
Primary objective:
To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.
Read more
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives:
- To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
- To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
- Being tested
- M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
- Keywords
- Prevention of : Measles, Mumps, Rubella and Varicella diseases
- Medical subject headings
- Measles, Mumps, Chickenpox, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®Biological
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 start20 Jan 2005
- Primary completion5 Sep 2005
- Study completion5 Sep 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 MeaslesStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 752 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
- NCT00432523
- Sponsor's protocol ID
- V205C-011
- Other IDs
- X04-MMRr-301
- Status last verified
- Oct 2021
- First submitted
- 7 Feb 2007
- Last updated
- 18 Oct 2021
- Results posted
- No
Publications
Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16. doi: 10.1186/1741-7015-7-16.
PubMed 19366435
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age
- ClinicalTrials.gov ID
- NCT00432523
- Acronym / sponsor ID
- V205C-011
- Keywords
- Prevention of : Measles, Mumps, Rubella and Varicella diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2005 (actual)
- Primary completion
- 5 Sep 2005 (actual)
- Study completion
- 5 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 compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.
AND/OR
To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination
Secondary objectives:
- To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
- To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy subject of either gender,
- Age 12 to 18 months ,
- Consent form signed by both parent(s) or by the legal representative properly informed about the study,
- Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Key exclusion criteria (14 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 recent (≤30 days) exposure to measles, mumps or rubella,
- Any recent (≤30 days) exposure to varicella or zoster involving:
- Any recent (≤3 days) history of febrile illness
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 |
|---|---|---|
| M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® | 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 18 Oct 2021.
- Derived from this study: PubMed 19366435Gillet Y, Habermehl P, Thomas S, Eymin C, Fiquet A. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009 Apr 14;7:16. doi: 10.1186/1741-7015-7-16.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® in people with Measles and Mumps, run by Merck Sharp & Dohme LLC at 2 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 4 inclusion and 14 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 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00432523, 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 18 Oct 2021.