NCT00432523

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (planned)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

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.

Conditions

• Measles
• Mumps
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®

Timeline

• Start date: 2005-01-20
• Primary completion: 2005-09-05
• Completion: 2005-09-05
• First posted: 2007-02-08
• Last updated: 2021-10-18

Locations

2 sites across 2 countries: France, Germany