A Phase 3 interventional study of Candidate varicella vaccine and Marketed varicella vaccine in Chickenpox, sponsored by GlaxoSmithKline. Recruiting at 22 sites in 7 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 911 is above the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Prior/Concomitant therapy
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:
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.
Prior/Concurrent clinical study experience
Other exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Candidate varicella vaccine · Biological: MMR vaccine · Biological: Hepatitis A vaccine · Biological: PCV (pneumococcal conjugate vaccine) 13 · Biological: PCV 20 · Biological: Vaxneuvance
Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Marketed varicella vaccine · Biological: MMR vaccine · Biological: Hepatitis A vaccine · Biological: PCV (pneumococcal conjugate vaccine) 13 · Biological: PCV 20 · Biological: Vaxneuvance
Investigational varicella vaccine administered intramuscularly.
Marketed varicella vaccine administered subcutaneously.
MMR vaccine administered subcutaneously or intramuscularly.
Hepatitis A vaccine co-administered intramuscularly.
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.
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.
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.
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG)
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.
Time frame: At Day 43
Geometric Mean Concentration (GMC) of anti-VZV gE IgG
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
Time frame: At Day 43
Percentage of participants with seroresponse to MMR antigens
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.
Time frame: At Day 43
GMC of Anti-measles antibodies
Time frame: At Day 43
GMC of Anti-mumps antibodies
Time frame: At Day 43
GMC of Anti-rubella antibodies
Time frame: At Day 43
Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine
Time frame: At Day 43
Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin
Time frame: At Day 43
Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration
Solicited administration site events include injection site redness, pain, and swelling.
Time frame: Day 1 (post-dose) to Day 4
Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 1 (post-dose) to Day 4
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 1 (post-dose) to Day 15
Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration
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).
Time frame: Day 1 (post-dose) to Day 22
Percentage of participants reporting each solicited administration site events post-dose of study interventions administration
Solicited administration site events include injection site varicella-like rash.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting each solicited systemic events post-dose of study interventions administration
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).
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration
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.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration
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.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration
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.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
Not enrolling at this site — choose another above.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
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