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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00432523

Enrollment

752

Registered

2007-02-08

Start date

2005-01-20

Completion date

2005-09-05

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Varicella

Keywords

Prevention of : Measles, Mumps, Rubella and Varicella diseases

Brief 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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

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

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026