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
Overview
- Phase
- Phase 2
- Intervention
- Investigational MMRV(H)NS vaccine
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline
- Enrollment
- 801
- Locations
- 1
- Primary Endpoint
- GMC of Anti-measles Antibodies at Day 43
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Detailed Description
This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared with the licensed measles, mumps, rubella, varicella vaccine, ProQuad (referred to as the MMRV vaccine), when given as a second dose to children 4 to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s). This study will evaluate immunogenicity and safety using 3 MMRVNS formulations which vary for some or all the individual virus potencies. The 3 MMRVNS formulations (designated as MMRV(H)NS vaccine, MM(H)RVNS vaccine and M(L)M(L)R(L)V(L)NS vaccine) will be compared with the MMRV vaccine. To ensure representative data on the comparator, participants enrolled in the MMRV group will be randomized to two different lots (designated as MMRV_Lot 1 and MMRV_Lot 2). Throughout the study, the two lots will be analyzed as a pooled group.
Investigators
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.
Arms & Interventions
MMRV(H)NS Group
Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.
Intervention: Investigational MMRV(H)NS vaccine
MM(H)RVNS Group
Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.
Intervention: Investigational MM(H)RVNS vaccine
M(L)M(L)R(L)V(L)NS Group
Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Intervention: Investigational M(L)M(L)R(L)V(L)NS vaccine
MMRV_Lot 1 and Lot 2 Pooled Group
Participants receive a single 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.
Intervention: Marketed MMRV_Lot 1 and Lot 2 vaccine
Outcomes
Primary Outcomes
GMC of Anti-measles Antibodies at Day 43
Time Frame: At Day 43
Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.
GMC of Anti-mumps Antibodies at Day 43
Time Frame: At Day 43
Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
GMC of Anti-rubella Antibodies at Day 43
Time Frame: At Day 43
Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43
Time Frame: At Day 43
Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Secondary Outcomes
- Percentage of Participants With Seroresponse for Measles Antibodies at Day 43(At Day 43)
- Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43(At Day 43)
- Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43(At Day 43)
- Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43(At Day 43)
- Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration(Day 1 to Day 4)
- Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration(Day 1 to Day 4)
- Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration(Day 1 to Day 43)
- Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration(Day 1 to Day 43)
- Number of Participants With SAEs After Vaccine Dose Administration(Throughout the study period (Day 1 to Day 181))