Chickenpox
Conditions
Keywords
Chicken pox, Candidate l varicella vaccine (VNS), Varicella, Varivax, Healthy Children
Brief 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.
Interventions
BIOLOGICALCandidate varicella vaccine
Investigational varicella vaccine administered intramuscularly.
BIOLOGICALMarketed varicella vaccine
Marketed varicella vaccine administered subcutaneously.
BIOLOGICALMMR vaccine
MMR vaccine administered subcutaneously or intramuscularly.
BIOLOGICALHepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
BIOLOGICALPCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
BIOLOGICALPCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
BIOLOGICALVaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an Open Label study.
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) | 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 | 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 | 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 | At Day 43 | — |
| GMC of Anti-mumps antibodies | At Day 43 | — |
| GMC of Anti-rubella antibodies | At Day 43 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting each solicited administration site events post-dose of study interventions administration | Day 1 (post-dose) to Day 43 | Solicited administration site events include injection site varicella-like rash. |
| Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration | 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 with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine | At Day 43 | — |
| Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration | 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. |
| Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration | 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 with seroresponse to MMR antigens with a reduced non-inferiority margin | At Day 43 | — |
| Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration | 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 | 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 | 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 | 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). |
Countries
Belgium, United States
Contacts
Primary ContactUS GSK Clinical Trials Call Center
Backup ContactEU GSK Clinical Trials Call Center
Outcome results
None listed