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
- 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.
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-10-14
- First posted
- 2022-11-30
- Registry last updated
- 2025-06-22
- Primary completion date
- 2024-06-07
- Start date
- 2022-12-14
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05630846
- ClinicalTrials.gov ID
- NCT05630846
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masking description
- Single-blind study. Recipients and care providers will be unaware of vaccine administered.
- Masked roles
- Participants, Care providers
GMC of Anti-measles Antibodies at Day 43
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
Percentage of Participants With Seroresponse for Measles Antibodies at Day 43
Timeframe: At Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 measles antibodies concentration was \>=116 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43
Timeframe: At Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 mumps antibodies concentration was \>=296 AU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43
Timeframe: At Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 rubella antibodies concentration was \>=24 IU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43
Timeframe: At Day 43
Seroresponse was defined as the participants of participants for whom the Day 43 varicella antibodies concentration was \>=300 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration
Timeframe: Day 1 to Day 4
The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Analysis was performed on exposed set which included all participants who received a study intervention. Only those participants with solicited AEs were included in this analysis.
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration
Timeframe: Day 1 to Day 4
The solicited systemic events after vaccination included drowsiness and loss of appetite. Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration
Timeframe: Day 1 to Day 43
The solicited systemic events after vaccination included fever, measles/rubella-like rash, varicella- like rash and other rash (not measles/rubella-like rash or varicella-like rash). Fever was defined as temperature greater than or equal to 38.0 degrees Celsius (100.4 degrees Fahrenheit) by any route (the preferred location for measuring temperature is the axilla). Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.
Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration
Timeframe: Day 1 to Day 43
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or was included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events. Unsolicited AEs must have been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious adverse events (SAEs) and non-serious AEs. Analysis was performed on exposed set.
Number of Participants With SAEs After Vaccine Dose Administration
Timeframe: Throughout the study period (Day 1 to Day 181)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or other significant medical events. Analysis was performed on exposed set.
- Sex
- All
- Age groups
- Children
- Minimum age
- 4 Years
- Maximum age
- 6 Years
- Healthy volunteers
- Yes
- 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).
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.
- GSK Investigational SiteBirmingham, United States
- GSK Investigational SiteJonesboro, United States
- GSK Investigational SiteBellflower, United States
- GSK Investigational SiteHuntington Park, United States
- GSK Investigational SiteOakland, United States
- GSK Investigational SiteRoseville, United States
- GSK Investigational SiteSacramento, United States
- GSK Investigational SiteSacramento, United States
- GSK Investigational SiteSan Jose, United States
- GSK Investigational SiteSanta Clara, United States
- GSK Investigational SiteWest Covina, United States
- GSK Investigational SiteMiami Lakes, United States
- GSK Investigational SiteTampa, United States
- GSK Investigational SiteAmmon, United States
- GSK Investigational SiteIdaho Falls, United States
- GSK Investigational SiteLouisville, United States
- GSK Investigational SiteLafayette, United States
- GSK Investigational SiteBoston, United States
- GSK Investigational SiteBingham Farms, United States
- GSK Investigational SiteDetroit, United States
- GSK Investigational SiteLincoln, United States
- GSK Investigational SiteLincoln, United States
- GSK Investigational SiteOmaha, United States
- GSK Investigational SiteSyracuse, United States
- GSK Investigational SiteCleveland, United States
And 22 more, listed on the interactive page.
Other registry identifiers
- 2022-501564-18
Related records
Drugs (2)
- Feverfew
- Menadiol sodium sulfate
Lead sponsors (1)
Conditions (4)
- Chickenpox
- Measles Primary condition
- Mumps infectious disease
- Rubella