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CompletedNCT00432523Updated Oct 18, 2021

Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)

A Phase 3 interventional study of M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® in Measles, Mumps and Varicella, sponsored by Merck Sharp & Dohme LLC. Completed at 2 sites in 2 countries. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3 and Interventional

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jan 2005, registered Feb 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
752
Allocation
Randomized
Ages
12 Months to 18 Months
Sex
All
01

Study 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 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.
02

Conditions studied

  • Measles
  • Mumps
  • Varicella

Keywords

  • Prevention of : Measles, Mumps, Rubella and Varicella diseases
03

In context

Measles

134 studies on the registry are indexed under Measles; 17 are open to participants now.

This study's enrollment of 752 is below the median of 852 across 105 interventional studies indexed under Measles.

Browse Measles studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.

Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy subject of either gender,
  2. Age 12 to 18 months ,
  3. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
  4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

Exclusion Criteria:

  1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
  2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
  3. Any recent (≤30 days) exposure to measles, mumps or rubella,
  4. Any recent (≤30 days) exposure to varicella or zoster involving:
  5. Any recent (≤3 days) history of febrile illness
  6. Any severe chronic disease,
  7. Active untreated tuberculosis,
  8. Known personal history of seizures,
  9. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
  10. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
  12. Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
  13. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
  14. Any recent receipt of an inactivated or a (≤30 days) or scheduled vaccination through visit 2
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
752 participants

Interventions

  • BiologicalM-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
06

Study locations

2 sites
  • France, France
  • Germany, Germany
07

References and documents

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 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00432523
Responsible party
Sponsor
First posted
Feb 8, 2007
Start date
Jan 20, 2005
Primary completion
Sep 5, 2005
Completion
Sep 5, 2005
Last update
Oct 18, 2021

Study contacts

Anne FIQUET, MD
study director · SPMSD
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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