ChickenpoxPhase 3NCT06806137
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
A Phase 3 study testing Investigational varicella vaccine, Marketed varicella vaccine and MMR vaccine in people with Chickenpox, run by GlaxoSmithKline at 6 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox
- What is being tested?
- Investigational varicella vaccine, Marketed varicella vaccine and MMR vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 May 2025to 3 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- 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 the first 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 study entry.
Who cannot join
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- Recurrent history of uncontrolled neurological disorders or seizures.
- History of varicella disease.
Show all 24Show fewer
- Active untreated tuberculosis.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- 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 first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
- Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.
- 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 vaccinese.g., nirsevimab), antitumoral medication.
- Previous vaccination against measles, mumps, and rubella.
- Previous vaccination against hepatitis A virus.
- Previous vaccination against varicella 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.
- 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).
- 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. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Dominican Republic3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Constanza, 11201
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salvaleón de Higüey, La Altagracia Province, 23000
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Santo Domingo Oeste, 11906
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Honduras3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
San Pedro Sula, 21104
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tegucigalpa, 11101
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tegucigalpa, 2449
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
- Conditions
- Chickenpox
- Being tested
- Investigational varicella vaccine, Marketed varicella vaccine, MMR vaccine, Hepatitis A vaccine, PCV (pneumococcal conjugate vaccine) 13
- Keywords
- Chicken pox, Investigational varicella vaccine (VNS) Varicella, Varivax (VV), Healthy Children
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational varicella vaccineBiological
Investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccineBiological
Marketed varicella vaccine administered subcutaneously.
MMR vaccineBiological
MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccineBiological
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13Biological
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.
PCV 20Biological
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.
VaxneuvanceBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| VV-VV Group | Active comparator | Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 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. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. Receives: Biological: Marketed varicella vaccine; Biological: MMR vaccine; Biological: Hepatitis A vaccine; Biological: PCV (pneumococcal conjugate vaccine) 13; Biological: PCV 20; Biological: Vaxneuvance |
| VNS-VNS Group | Experimental | Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. Receives: Biological: Investigational varicella vaccine; Biological: MMR vaccine; Biological: Hepatitis A vaccine; Biological: PCV (pneumococcal conjugate vaccine) 13; Biological: PCV 20; Biological: Vaxneuvance |
| VV-VNS Group | Experimental | Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. Receives: Biological: Investigational varicella vaccine; Biological: Marketed varicella vaccine; Biological: MMR vaccine; Biological: Hepatitis A vaccine; Biological: PCV (pneumococcal conjugate vaccine) 13; Biological: PCV 20; Biological: Vaxneuvance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (>=) 300 milli-international units per milliliter (mIU/mL).
Measured: At Day 133 (43 days post-dose 2)
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
Measured: At Day 133 (within 43 days post-dose 2)
Secondary outcomes (16)
Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti-VZV gE IgG concentration >= 300 mIU/mL.
Measured: At Day 133 (within 43 days post-dose 2)
GMC of anti-VZV gE IgG for VV-VNS group
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
Measured: At Day 133 (within 43 days post-dose 2)
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Measured: Day 1 (post-dose 1) to Day 4
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Measured: Day 91 (post-dose 2) to Day 94
Percentage of participants reporting each solicited systemic event
Solicited systemic events include drowsiness, loss of appetite and irritability.
Measured: Day 1 (post-dose 1) to Day 15
Percentage of participants reporting each solicited systemic event
Solicited systemic events include drowsiness, loss of appetite and irritability.
Measured: Day 91 (post-dose 2) to Day 105
Percentage of participants reporting each solicited systemic event in terms of fever
Fever is defined as temperature >=38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla).
Measured: Day 1 (post-dose 1) to Day 22
Percentage of participants reporting each solicited systemic event in terms of fever
Fever is defined as temperature >=38.0 degrees °C by any route (the preferred location for measuring temperature is the axilla).
Measured: Day 91 (post-dose 2) to Day 112
Percentage of participants reporting each solicited administration site event
Solicited administration site include injection site varicella-like rash.
Measured: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited administration site event
Solicited administration site include injection site varicella-like rash.
Measured: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting each solicited systemic event
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
Measured: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited systemic event
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
Measured: Day 91 (post-dose 2) to Day 133
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.
Measured: Day 1 (post-dose 1) 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.
Measured: Day 91 (post-dose 2) to Day 133
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.
Measured: Day 1 (post-dose 1) to Day 271 (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.
Measured: Day 1 (post-dose 1) to Day 271 (study end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 May 2025
- Primary completion14 Dec 2026 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChickenpoxStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806137
- Sponsor's protocol ID
- 214002
- Other IDs
- 2024-516635-27-00
- Status last verified
- May 2026
- First submitted
- 31 Jan 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
- ClinicalTrials.gov ID
- NCT06806137
- Acronym / sponsor ID
- 214002
- Conditions
- Chickenpox
- Keywords
- Chicken pox, Investigational varicella vaccine (VNS) Varicella, Varivax (VV), Healthy Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VV-VV Group | Active comparator | Biological: Marketed varicella vaccine, Biological: MMR vaccine, Biological: Hepatitis A vaccine, Biological: PCV (pneumococcal conjugate vaccine) 13, Biological: PCV 20, Biological: VaxneuvanceParticipants receive 2 doses of a VV vaccine on Day 1 and Day 91. 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. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
| VNS-VNS Group | Experimental | Biological: Investigational varicella vaccine, Biological: MMR vaccine, Biological: Hepatitis A vaccine, Biological: PCV (pneumococcal conjugate vaccine) 13, Biological: PCV 20, Biological: VaxneuvanceParticipants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
| VV-VNS Group | Experimental | Biological: Investigational varicella vaccine, Biological: Marketed varicella vaccine, Biological: MMR vaccine, Biological: Hepatitis A vaccine, Biological: PCV (pneumococcal conjugate vaccine) 13, Biological: PCV 20, Biological: VaxneuvanceParticipants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- 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 the first 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 study entry.
Key exclusion criteria (24 listed)
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- Recurrent history of uncontrolled neurological disorders or seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational varicella vaccineInvestigational varicella vaccine administered subcutaneously. | Biological | VNS-VNS Group, VV-VNS Group |
| Marketed varicella vaccineMarketed varicella vaccine administered subcutaneously. | Biological | VV-VNS Group, VV-VV Group |
| MMR vaccineMMR vaccine co-administered subcutaneously or intramuscularly. | Biological | VNS-VNS Group, VV-VNS Group, VV-VV Group |
| Hepatitis A vaccineHepatitis A vaccine co-administered intramuscularly. | Biological | VNS-VNS Group, VV-VNS Group, VV-VV Group |
| PCV (pneumococcal conjugate vaccine) 13The 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. | Biological | VNS-VNS Group, VV-VNS Group, VV-VV Group |
| PCV 20The 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. | Biological | VNS-VNS Group, VV-VNS Group, VV-VV Group |
| VaxneuvanceThe 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. | Biological | VNS-VNS Group, VV-VNS Group, VV-VV Group |
Primary outcome
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Time frame: At Day 133 (43 days post-dose 2)
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (>=) 300 milli-international units per milliliter (mIU/mL).
Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV
Time frame: At Day 133 (within 43 days post-dose 2)
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
16 secondary outcomes
Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group
Time frame: At Day 133 (within 43 days post-dose 2)
GMC of anti-VZV gE IgG for VV-VNS group
Time frame: At Day 133 (within 43 days post-dose 2)
Percentage of participants reporting each solicited administration site event
Time frame: Day 1 (post-dose 1) to Day 4
Percentage of participants reporting each solicited administration site event
Time frame: Day 91 (post-dose 2) to Day 94
Percentage of participants reporting each solicited systemic event
Time frame: Day 1 (post-dose 1) to Day 15
Percentage of participants reporting each solicited systemic event
Time frame: Day 91 (post-dose 2) to Day 105
Percentage of participants reporting each solicited systemic event in terms of fever
Time frame: Day 1 (post-dose 1) to Day 22
Percentage of participants reporting each solicited systemic event in terms of fever
Time frame: Day 91 (post-dose 2) to Day 112
Percentage of participants reporting each solicited administration site event
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited administration site event
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting each solicited systemic event
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting each solicited systemic event
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting unsolicited adverse events (AEs)
Time frame: Day 1 (post-dose 1) to Day 43
Percentage of participants reporting unsolicited adverse events (AEs)
Time frame: Day 91 (post-dose 2) to Day 133
Percentage of participants reporting medically attended AEs (MAAE)
Time frame: Day 1 (post-dose 1) to Day 271 (study end)
Percentage of participants reporting serious adverse events (SAEs)
Time frame: Day 1 (post-dose 1) to Day 271 (study end)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational varicella vaccine, Marketed varicella vaccine and MMR vaccine in people with Chickenpox, run by GlaxoSmithKline at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Dominican Republic, Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV (time frame: At Day 133 (43 days post-dose 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.