Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine designed to protect against measles, mumps, rubella, and chickenpox in a single shot. Researchers aim to assess how well children's immune systems respond to different vaccine strengths and ensure its safety. Children aged 4 to 6 who received their first doses of these vaccines around age 2 and are generally healthy may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important vaccine development.
Will I have to stop taking my current medications?
The trial requires that participants do not use any investigational or non-registered products, chronic immunosuppressants, or immune-modifying drugs starting 30 to 90 days before the study. Inhaled and topical steroids are allowed, but other medications may need to be stopped.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the vaccines under study are likely safe for children. For the MMRV(H)NS vaccine, past studies involving over 83,000 children found no major safety issues. These studies revealed no strong signs of serious side effects, though there might be a slightly higher chance of mild reactions, such as fever, after the shot.
Similarly, studies have shown the M(L)M(L)R(L)V(L)NS vaccine to be safe. Evidence suggests that this vaccine is generally well-tolerated, with most children experiencing only mild issues, if any.
The MM(H)RVNS vaccine also appears safe. Research indicates no increased risk of fever-related convulsions for children aged 4 to 6 who receive this vaccine, suggesting it is relatively safe for this age group.
In summary, all these vaccines have been tested in children, and findings support their safety, with mostly mild side effects reported.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these investigational vaccines for children's immunization because they offer innovative combinations and potencies of the measles, mumps, rubella, and chickenpox (varicella) vaccines. The MMRV(H)NS vaccine includes varicella at a high potency, which could enhance protection compared to standard vaccines. The MM(H)RVNS vaccine provides mumps at a high potency, potentially offering stronger immunity against this virus. Meanwhile, the M(L)M(L)R(L)V(L)NS vaccine features all components at low potency, which could minimize side effects while maintaining effectiveness. These variations in potency and combination are what make these treatments distinct, potentially offering more tailored protection for children.
What evidence suggests that this trial's vaccines could be effective for children's immunization?
Research has shown that vaccines like the MMRV (measles, mumps, rubella, varicella) effectively prevent these diseases. One study found the vaccine to be 94.1% effective at preventing measles in a large group who received two doses. Another study showed the varicella vaccine was 92% effective in preventing moderate or severe illness. These vaccines have also proven very safe, with no major safety issues identified. In this trial, participants will receive one of several investigational vaccines, including M(L)M(L)R(L)V(L)NS, MM(H)RVNS, MMRV(H)NS, or a marketed MMRV vaccine. This evidence supports the effectiveness and safety of the investigational vaccines in protecting against these diseases.13678
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
Healthy children aged 4-6 who've had their first measles, mumps, rubella, and chickenpox vaccines. They must not have immune system issues or severe reactions to vaccine components like neomycin or gelatin. Parents must consent and be able to follow the study's requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 1 dose of the investigational or marketed vaccine on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for serious adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Investigational M(L)M(L)R(L)V(L)NS vaccine
- Investigational MM(H)RVNS vaccine
- Investigational MMRV(H)NS vaccine
- Marketed MMRV_Lot 1 and Lot 2 vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School