Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular… (NCT00432523) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
France, Germany752 participantsStarted 2005-01-20
Plain-language 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.
Who can participate
Age range12 Months – 18 Months
SexALL
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Inclusion criteria
âś“. Healthy subject of either gender,
âś“. Age 12 to 18 months ,
âś“. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
âś“. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion criteria
âś•. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
âś•. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
✕. Any recent (≤30 days) exposure to measles, mumps or rubella,
✕. Any recent (≤30 days) exposure to varicella or zoster involving:
✕. Any recent (≤3 days) history of febrile illness