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 range
12 Months – 18 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy subject of either gender,
. Age 12 to 18 months ,
. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion criteria
. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.