Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization

Recruiting at 63 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Immunodeficient, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

801 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the immune response and safety of different strengths of a combined vaccine for measles, mumps, rubella, and chickenpox in young children. The combination vaccine has been shown to be an effective and safe approach to immunization in healthy children.

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.

What data supports the effectiveness of the treatment Combined Measles-Mumps-Rubella-Chickenpox Vaccine for Children's Immunization?

Research shows that the combined measles-mumps-rubella-varicella (MMRV) vaccine is effective in creating strong immune responses in children, with more than 95% developing immunity to these diseases. Studies also indicate that the MMRV vaccine provides a similar level of protection as separate vaccines for these diseases, with enhanced immune response to measles. ^{1 2 3 4 5}

Is the combined measles-mumps-rubella-chickenpox vaccine safe for children?

Research shows that the combined measles-mumps-rubella-varicella (MMRV) vaccine is generally well tolerated in children, with studies indicating it is safe when given alone or with other vaccines. Most children developed immunity to the diseases, although the response to chickenpox was slightly lower when given as part of the MMRV compared to a separate chickenpox vaccine. ^{2 3 5 6 7}

How is the Investigational M(L)M(L)R(L)V(L)NS vaccine different from other vaccines for children's immunization?

The Investigational M(L)M(L)R(L)V(L)NS vaccine is unique because it combines protection against measles, mumps, rubella, and chickenpox into a single shot, which is more convenient and potentially more cost-effective than receiving separate vaccines for each disease. ^{2 5 8 9 10}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

I received a chickenpox vaccine in my second year of life.

Healthy participants as established by medical history and clinical examination before entering into the study

Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure

Exclusion Criteria

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin

History of measles, mumps, rubella, or varicella disease

Hypersensitivity to latex

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 dose of the investigational or marketed vaccine on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

43 days

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for serious adverse events

181 days

Treatment Details

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

Trial Overview The trial is testing different strengths of a combined measles, mumps, rubella, and chickenpox (MMRVNS) vaccine against two standard doses of a marketed MMRV vaccine in healthy kids to see how well they respond and if it's safe.

Participant Groups

Group I: MMRV(H)NS Group Experimental Treatment 1 Intervention

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.

Group II: MM(H)RVNS Group Experimental Treatment 1 Intervention

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.

Group III: M(L)M(L)R(L)V(L)NS Group Experimental Treatment 1 Intervention

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.

Group IV: MMRV_Lot 1 and Lot 2 Pooled Group Active Control 1 Intervention

Healthy children aged 4 to 6 years of age receive 1 dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

Findings from Research

From 2006 to 2020, the single-antigen varicella vaccine (VAR) and the combination measles, mumps, rubella, and varicella vaccine (MMRV) showed favorable safety profiles, with serious adverse events reported at rates of 1.3 per 100,000 doses for both vaccines.

The most common adverse events were mild, such as injection site reactions and fever, and no new or unexpected safety issues were identified, reinforcing the vaccines' safety when administered as recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. Moro, PL., Leung, J., Marquez, P., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Measles, mumps, rubella, and varicella combination vaccine: safety and immunogenicity alone and in combination with other vaccines given to children. Measles, Mumps, Rubella, Varicella Vaccine Study Group. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of early vaccination with two doses of a combined measles-mumps-rubella-varicella vaccine in healthy Indian children from 9 months of age: a phase III, randomised, non-inferiority trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Combination Measles-Mumps-Rubella-Varicella Vaccine in Healthy Children: A Systematic Review and Meta-analysis of Immunogenicity and Safety. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of early vaccination with two doses of tetravalent measles-mumps-rubella-varicella (MMRV) vaccine in healthy children from 9 months of age. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine: an open-labeled, randomized trial in healthy Korean children. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. [2013]

9. Brazil pubmed.ncbi.nlm.nih.gov

Varicella vaccines and measles, mumps, rubella, and varicella vaccine. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. [2019]