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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05630846

Collaborator

(none)

800

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Measles; Mumps; Rubella; Chickenpox	Biological: 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	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Single-blind study. recipients and care providers will be unaware of vaccine administered.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 14, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jun 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MMRV(H)NS Group 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.	Biological: Investigational MMRV(H)NS vaccine 1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
Experimental: MM(H)RVNS Group 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.	Biological: Investigational MM(H)RVNS vaccine 1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
Experimental: M(L)M(L)R(L)V(L)NS Group 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.	Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine 1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Active Comparator: MMRV_Lot 1 and Lot 2 Pooled Group 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.	Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously. Other Names: ProQuad

Outcome Measures

Primary Outcome Measures

Anti-measles antibody geometric mean concentrations (GMCs) [At Day 43]
Antibody GMCs will be summarized for measles antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against measles antigen. Antibody concentrations will be presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-mumps antibody GMCs [At Day 43]
Antibody GMCs will be summarized for mumps antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against mumps antigen. Antibody concentrations will be presented as GMCs, expressed in Arbitrary unit per milliliter (AU/mL).
Anti-rubella antibody GMCs [At Day 43]
Antibody GMCs will be summarized for rubella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against rubella antigen. Antibody concentrations will be presented as GMCs, expressed in International unit per milliliter (IU/mL).
Anti-glycoprotein E (gE) antibody GMCs [At Day 43]
Antibody GMCs will be summarized for varicella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against varicella antigen. Anti gE antibody concentrations will be presented as GMCs, expressed in mIU/mL

Secondary Outcome Measures

Percentage of participants with seroresponse to anti-measles antibodies [Day 43]
Seroresponse rate for measles is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-measles Multiplex Luminex based Immuno assay is greater than or equal to (>=) 67 mIU/mL for each group.
Percentage of participants with seroresponse to anti-mumps antibodies [Day 43]
Seroresponse rate for mumps is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-mumps Multiplex Luminex based Immuno assay is >= 296 AU/mL for each group.
Percentage of participants with seroresponse to anti-rubella antibodies [Day 43]
Seroresponse rate for rubella is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-rubella Multiplex Luminex based Immuno assay is >= 17 IU/mL for each group.
Percentage of participants with seroresponse to varicella anti-gE antibodies [Day 43]
Seroresponse rate for varicella is defined as the percentage of participants for whom the post-dose anti-gE antibody concentration is >= 300 mIU/mL for each group.
Percentage of participants reporting each solicited administration site event [During the 4-day period (day of administration and 3 following days) after the administration of study interventions (administered at Day 1)]
Solicited administration site events include injection site redness, pain and swelling.
Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite [During the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1)]
Solicited systemic events include drowsiness, loss of appetite, after the administration of study intervention for each group.
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) [During the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at Day 1)]
Solicited systemic events include fever, measles/rubella-like rash, or varicella like rash, and other rash (not measles/rubella-like rash or varicella-like rash) after the administration of study interventions for each group. Fever is defined as temperature greater than or equal to (>=)38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route (the preferred location for measuring temperature is the axilla).
Percentage of participants reporting unsolicited adverse events (AEs) [During the 43-day (day of administration and 42 following days) period after the administration of study interventions (administered at Day 1)]
Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.
Percentage of participants reporting serious adverse events (SAEs) [Throughout the entire study period (From Day 1 to Day 181)]
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
2	GSK Investigational Site	Tampa	Florida	United States	33613
3	GSK Investigational Site	Louisville	Kentucky	United States	40291
4	GSK Investigational Site	Lincoln	Nebraska	United States	68505
5	GSK Investigational Site	Dayton	Ohio	United States	45414
6	GSK Investigational Site	Tullahoma	Tennessee	United States	37388
7	GSK Investigational Site	Layton	Utah	United States	84041
8	GSK Investigational Site	Provo	Utah	United States	84604
9	GSK Investigational Site	Roy	Utah	United States	84067
10	GSK Investigational Site	South Jordan	Utah	United States	84095