A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
- Summary
- This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
- Short title
- A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
- Official title
- A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-02-02
- First posted
- 2025-03-03
- Registry last updated
- 2026-05-29
- Primary completion date
- 2026-09-10
- Start date
- 2025-04-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- GlaxoSmithKline
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06855160
- ClinicalTrials.gov ID
- NCT06855160
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
- Masking description
- This is an Open Label study.
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)
Timeframe: At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
Geometric Mean Concentration (GMC) of anti-VZV gE IgG
Timeframe: At Day 43
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
Percentage of participants with seroresponse to MMR antigens
Timeframe: At Day 43
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
GMC of Anti-measles antibodies
Timeframe: At Day 43
GMC of Anti-mumps antibodies
Timeframe: At Day 43
GMC of Anti-rubella antibodies
Timeframe: At Day 43
Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine
Timeframe: At Day 43
Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin
Timeframe: At Day 43
Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration
Timeframe: Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain, and swelling.
Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration
Timeframe: Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain and swelling.
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 15
Solicited systemic events include drowsiness, loss of appetite and irritability.
Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 22
Fever is defined as temperature greater than or equal (\>=) 38.0 degrees Celsius (°C) regardless of the location of measurement (the preferred location for measuring temperature is the axilla).
Percentage of participants reporting each solicited administration site events post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 43
Solicited administration site events include injection site varicella-like rash.
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 43
Solicited systemic events includes varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella like and not measles/rubella-like).
Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 43
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. Unsolicited AEs include nonserious and serious AEs.
Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 181 (Study end)
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration
Timeframe: Day 1 (post-dose) to Day 181 (Study end)
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.
- Sex
- All
- Age groups
- Children
- Minimum age
- 12 Months
- Maximum age
- 15 Months
- Healthy volunteers
- Yes
-
Participant's parent(s)/ Legally acceptable representatives (LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
-
Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
-
Healthy participants as established by medical history and clinical examination before entering into the study.
-
A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.
-
Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions:
- Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to the administration of study intervention.
- 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.
- Recurrent history of uncontrolled neurological disorders or seizures.
- History of measles, mumps, rubella, or varicella disease.
- Active untreated tuberculosis.
- Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).
- Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- 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/Concomitant therapy
-
Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.
-
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
- Up to 90 days prior to the study intervention administration:
-
For corticosteroids, this will mean prednisone equivalent >=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
-
Administration of immunoglobulins and/or any blood products or plasma derivatives.
- Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines, e.g., nirsevimab), antitumoral medication.
-
Previous vaccination against measles, mumps, and rubella.
-
Previous vaccination against varicella virus.
-
Previous vaccination against hepatitis A virus.
-
Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
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 exclusion criteria
- Any study personnel or their immediate dependents, family, or household members.
- Child in care.
- 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 SiteTucson, United StatesRecruiting
- GSK Investigational SiteHuntington Park, United StatesRecruiting
- GSK Investigational SiteSherman Oaks, United StatesRecruiting
- GSK Investigational SiteCoral Gables, United StatesRecruiting
- GSK Investigational SiteMiami Lakes, United StatesRecruiting
- GSK Investigational SiteTampa, United StatesRecruiting
- GSK Investigational SiteIdaho Falls, United StatesRecruiting
- GSK Investigational SiteDayton, United StatesRecruiting
- GSK Investigational SiteHouston, United StatesRecruiting
- GSK Investigational SiteLewisville, United StatesRecruiting
- GSK Investigational SiteMansfield, United StatesRecruiting
- GSK Investigational SitePharr, United StatesRecruiting
- GSK Investigational SiteRichmond, United StatesRecruiting
- GSK Investigational SiteAlken, BelgiumRecruiting
- GSK Investigational SiteTartu, EstoniaRecruiting
- GSK Investigational SiteAthens, GreeceWithdrawn
- GSK Investigational SiteAthens, GreeceRecruiting
- GSK Investigational SiteThessaloniki, GreeceRecruiting
- GSK Investigational SiteTrzebnica, PolandRecruiting
- GSK Investigational SiteBrasov, RomaniaRecruiting
- GSK Investigational SiteCalarasi, RomaniaRecruiting
- GSK Investigational SiteChiang Mai, ThailandRecruiting
Other registry identifiers
- 2024-518840-18-00
Related records
Drugs (8)
- Measles virus vaccine live
- Measles virus, live attenuated
- Mumps virus vaccine live
- Mumps virus, live attenuated
- Rubella virus vaccine live
- Rubella virus, live attenuated
- Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197
- Streptococcus pneumoniae polysaccharide conjugated to tetanus toxoid
Lead sponsors (1)
Conditions (1)
- Chickenpox Primary condition