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

Measles Clinical Trial

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

Status Completed

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Varicella

• NCT number: NCT00432523
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2005
• Completion date: September 5, 2005