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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00432523
Other study ID # V205C-011
Secondary ID X04-MMRr-301
Status Completed
Phase Phase 3
First received
Last updated
Start date January 20, 2005
Est. completion date September 5, 2005

Study information

Verified date October 2021
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 752
Est. completion date September 5, 2005
Est. primary completion date September 5, 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 18 Months
Eligibility 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: 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 live vaccine (=30 days) or scheduled vaccination through visit 2

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

France,  Germany, 

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