Clinical trial NCT05630846: 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
Official title: A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Measles; Mumps; Rubella; Chickenpox
Measles
Keywords: Measles
Mumps
Rubella
Varicella
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 801
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 according to the local immunization practices of the participating country.
* Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter.

  * In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local government recommendations and that GSK/IQVIA is notified accordingly.

Prior/Concurrent Clinical Study Experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).

Other Exclusions

* Child in care.
* Any study personnel's immediate dependents, family, or household members.
* Participants with the following high-risk individuals in their household:

  * Immunocompromised individuals
  * Pregnant women without documented history of varicella.
  * Newborn infants of mothers without documented history of varicella.
  * Newborn infants born \<28 weeks of gestation.

Primary outcomes:
measure: Anti-measles antibody geometric mean concentrations (GMCs)
timeFrame: At Day 43
measure: Anti-mumps antibody GMCs
timeFrame: At Day 43
measure: Anti-rubella antibody GMCs
timeFrame: At Day 43
measure: Anti-glycoprotein E (gE) antibody GMCs
timeFrame: At Day 43
Secondary outcomes:
measure: Percentage of participants with seroresponse to anti-measles antibodies
timeFrame: Day 43
measure: Percentage of participants with seroresponse to anti-mumps antibodies
timeFrame: Day 43
measure: Percentage of participants with seroresponse to anti-rubella antibodies
timeFrame: Day 43
measure: Percentage of participants with seroresponse to varicella anti-gE antibodies
timeFrame: Day 43
measure: Percentage of participants reporting each solicited administration site event
timeFrame: During the 4-day period (day of administration and 3 following days) after the administration of study interventions (administered at Day 1)
measure: Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite
timeFrame: During the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1)
measure: Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varicella-like rash)
timeFrame: During the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at Day 1)
measure: Percentage of participants reporting unsolicited adverse events (AEs)
timeFrame: During the 43-day (day of administration and 42 following days) period after the administration of study interventions (administered at Day 1)
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: Throughout the entire study period (From Day 1 to Day 181)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Bellflower
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Park
country: United States
facility: GSK Investigational Site
state: California
city: Oakland
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Jose
country: United States
facility: GSK Investigational Site
state: California
city: Santa Clara
country: United States
facility: GSK Investigational Site
state: California
city: West Covina
country: United States
facility: GSK Investigational Site
state: California
city: Miami Lakes
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Ammon
country: United States
facility: GSK Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: GSK Investigational Site
state: Idaho
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: GSK Investigational Site
state: Michigan
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Simpsonville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Tullahoma
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dickinson
country: United States
facility: GSK Investigational Site
state: Texas
city: McAllen
country: United States
facility: GSK Investigational Site
state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Texas
city: Layton
country: United States
facility: GSK Investigational Site
state: Utah
city: Provo
country: United States
facility: GSK Investigational Site
state: Utah
city: Roy
country: United States
facility: GSK Investigational Site
state: Utah
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: San Juan
country: Puerto Rico
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: