Phase 2
N=796
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age
Measles; Mumps; Rubella; Chickenpox · Measles
Bottom Line
View on ClinicalTrials.gov: NCT05630846 ↗Enrolled (actual)
796
Serious AEs
0.5%
Results posted
Jun 2025
Primary outcome: Primary: GMC of Anti-measles Antibodies at Day 43 — 801; 788; 728; 682 mIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Investigational MMRV(H)NS vaccine (Biological); Investigational MM(H)RVNS vaccine (Biological); Investigational M(L)M(L)R(L)V(L)NS vaccine (Biological); Marketed MMRV_Lot 1 and Lot 2 vaccine (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GMC of Anti-measles Antibodies at Day 43 |
801; 788; 728; 682 | — |
| PRIMARY GMC of Anti-mumps Antibodies at Day 43 |
3369; 4770; 3114; 3176 | — |
| PRIMARY GMC of Anti-rubella Antibodies at Day 43 |
159; 178; 158; 149 | — |
| PRIMARY GMC of Anti-glycoprotein E (gE) Antibodies at Day 43 |
4229; 3743; 3369; 4002 | — |
| SECONDARY Percentage of Participants With Seroresponse for Measles Antibodies at Day 43 |
99.4; 98.2; 96.3; 95.2 | — |
| SECONDARY Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43 |
98.8; 100.0; 100.0; 99.4 | — |
| SECONDARY Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43 |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43 |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration |
76; 58; 64; 76; 41; 34 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration |
27; 18; 32; 31; 20; 14 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration |
27; 25; 25; 27; 13; 8 | — |
| SECONDARY Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration |
44; 37; 48; 53 | — |
| SECONDARY Number of Participants With SAEs After Vaccine Dose Administration |
1; 1; 1; 1 | — |
Summary
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
Eligibility Criteria
Inclusion Criteria
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
- Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
- Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life.
- Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
- Participants' 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 electronic diaries [eDiaries], return for follow-up visits).
Exclusion Criteria
Medical Conditions
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- History of measles, mumps, rubella, or varicella disease.
- Recurrent history of or uncontrolled neurological disorders or seizures.
- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever.
- Participant with history of coronavirus disease 2019 (COVID-19) who is still symptomatic.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior and Concomitant Therapy
- Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
- Previous vaccination with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine.
- Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3), with the exception of:
- inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions and,
- routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered a
Data sourced from ClinicalTrials.gov (NCT05630846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.