NCT00432523

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

Completed Phase 3 Last updated 18 October 2021

What this trial tests

Phase 3 trial testing M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® in Measles in 752 participants. Completed in 5 September 2005.

Timeline

20 January 2005

Primary endpoint
5 September 2005

5 September 2005

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Enrollment	752
Start date	20 January 2005
Primary completion	5 September 2005
Estimated completion	5 September 2005
Sites	2 locations across France, Germany

Drugs / interventions tested

• M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX® — full drug profile →

Conditions studied

• Measles — all drugs for Measles →
• Mumps — all drugs for Mumps →
• Varicella — all drugs for Varicella →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 12 Months to 18 Months, any sex, with Measles or Mumps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Gillet Y, Habermehl P, Thomas S, Eymin C, et al · · 2009 · cited 26× · PMID 19366435 · DOI 10.1186/1741-7015-7-16