A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella … (NCT07742644) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
United States, Argentina, Finland1,860 participantsStarted 2026-08-11
Plain-language summary
The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.
The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).
The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.
Who can participate
Age range
4 Years – 6 Years
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 (INC):
* INC#1 Participant's parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
* INC#2 Written or witnessed/thumb printed or digital informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study specific procedure.
* INC#3 Informed assent obtained from the participants in line with local rules and regulations.
* INC#4 Healthy participants as established by medical history and clinical examination at screening.
* INC#5 A male or female participant between and including 4 and 6 years of age (i.e., from fourth birthday until the day before the seventh birthday) at the time of the study interventions administration, and in accordance with local regulations.
* INC#6 Participant who previously received a first dose of varicella-containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
* INC#7 Participant who previously received a first dose of measles, mumps, rubella containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
* INC#8 Participant who previously received 3 or 4 doses of any combined DTP (DTaP/DTwP) vaccine (diphtheria and tetanus toxoids and pertussis antigens whether or not combined with h…
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.
What they're measuring
1
Geometric mean concentrations (GMCs) of immunoglobulin G (IgG) antibodies against measles, mumps, rubella, and varicella zoster virus (VZV) glycoprotein E (gE) after MMRVNS vaccine administration
Timeframe: At Day 43
2
Number of participants with seroresponse against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration
Timeframe: At Day 43
3
GMCs of IgG concentrations against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration