A Phase 3 interventional study of Investigational varicella vaccine_Lot 1 and Investigational varicella vaccine_Lot 2 in Chickenpox, sponsored by GlaxoSmithKline. Recruiting at 97 sites in 11 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
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 1,840 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:
Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified
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.
Participants with the following high-risk individuals in their household:
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 investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Investigational varicella vaccine_Lot 1 · Biological: MMR vaccine · Biological: Hepatitis A vaccine · Biological: PCV (pneumococcal conjugate vaccine) 13 · Biological: PCV 20 · Biological: Vaxneuvance
Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Investigational varicella vaccine_Lot 2 · Biological: MMR vaccine · Biological: Hepatitis A vaccine · Biological: PCV (pneumococcal conjugate vaccine) 13 · Biological: PCV 20 · Biological: Vaxneuvance
Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Investigational varicella vaccine_Lot 3 · 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) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Marketed varicella vaccine_Lot 1 · 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 VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Biological: Marketed varicella vaccine_Lot 2 · Biological: MMR vaccine · Biological: Hepatitis A vaccine · Biological: PCV (pneumococcal conjugate vaccine) 13 · Biological: PCV 20 · Biological: Vaxneuvance
Investigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine co-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 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.
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \[(antibody concentration less than (\<) LLOQ (Lower limit of quantification)\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
Time frame: At Day 43
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
Time frame: At Day 43
Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \>= 300 mIU/mL among participants who were seronegative (antibody concentration \< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
Time frame: At Day 43
GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
Time frame: At Day 43
Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time frame: At Day 43
Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time frame: At Day 43
Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Time frame: At Day 43
Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-measles will be defined by the laboratory before the analysis.
Time frame: At Day 43
Percentage of participants with seroresponse to anti-mumps for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-mumps antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-mumps will be defined by the laboratory before the analysis.
Time frame: At Day 43
Percentage of participants with seroresponse to anti-rubella for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups
Seroresponse is defined as post-vaccination (Day 43) anti-rubella antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-rubella will be defined by the laboratory before the analysis.
Time frame: At Day 43
Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in Hepatitis A virus (HAV) subset
Time frame: At Day 43
Percentage of participants with seroresponse to anti-HAV for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in HAV subset
Seroresponse is defined as post-vaccination (Day 43) anti-HAV antibody concentration \>= cut-off value among participants who were seronegative (antibody concentration \< cut-off value) before vaccination. The assay cut-off values for anti-HAV antibodies will be defined by the laboratory before the analysis.
Time frame: At Day 43
Anti-S. pneumoniae serotype specific Polysaccharide IgG antibody concentrations for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in PCV subset
S. pneumoniae polysaccharides to be tested: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Time frame: At Day 43
Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold
The adaptive seroresponse threshold is the anti-VZV gE IgG antibody concentration for which the response rate in the VV group is 95% or higher.
Time frame: At Day 43
Percentage of participants reporting each solicited administration site event
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 event
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
Fever is defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (°C) by any route (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 event
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 event
Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like).
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting unsolicited adverse events (AEs)
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.
Time frame: Day 1 (post-dose) to Day 43
Percentage of participants reporting medically attended AEs (MAAE)
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 adverse events (SAEs)
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)
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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
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 35 industry-sponsored phase 3 interventional studies under Chickenpox, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 15. This study's planned 23 months is above that.
Counting every sponsor, half of 39 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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