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Phase 2 N=796 Randomized Double-blind Prevention

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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