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CompletedNCT05084508Updated Feb 28, 2025Results posted

A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

A Phase 2 interventional study of Investigational varicella vaccine low potency and Investigational varicella vaccine medium potency in Chickenpox, sponsored by GlaxoSmithKline. Completed at 51 sites in 6 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
01

Study summary

The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.

Read the detailed description

The study aims to demonstrate the immunogenicity of the investigational VNS vaccine at three potencies (VNS_Low, VNS_Med, and VNS_High) compared to the licensed varicella vaccine, Varivax (VV), as a first dose for children aged 12 to 15 months in the US. To ensure more representative data, participants in the VV group are randomized into two lots (VV_Lot1 and VV_Lot2), which are analyzed as pooled lots throughout the study. Besides assessing immunogenicity, the study also seeks to generate safety data.

In the US, participants will receive additional vaccines: a measles, mumps, and rubella vaccine (MMR), a hepatitis A vaccine (Havrix), and a 13-valent pneumococcal conjugate vaccine (Prevnar 13). Participants outside the US will receive an MMR vaccine (M-M-R II or M-M-RVaxPro, depending on the country), Havrix, and, in some cases, Prevnar 13, but only in countries where it's recommended for children 12-15 months according to local immunization schedules.

At the end of the study, or shortly after, GSK provided re-vaccination with a dose of Varivax (VV) to participants who did not meet the pre-specified seroresponse threshold of anti-gE antibody concentration was greater than or equal to (>=) 300 mIU/mL. Additionally, a second dose of VV and/or Havrix was offered to participants in non-US countries where local health departments do not routinely provide varicella and/or hepatitis A vaccines.

02

Conditions studied

  • Chickenpox

Browse trials for

Keywords

  • Varicella
  • Chickenpox
03

In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's enrollment of 800 is above the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

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.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy participants as established by medical history and clinical examination before entering into the study.
  • A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the administration of the study interventions.
  • Written obtained from the parent(s)/legally authorized representative(s) of the participant prior to performance of any study-specific procedure.
  • Participants' parent(s)/legally authorized representative(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of Electronic Diaries, return for follow-up visits).
  • Only for US participants and participants in countries where pneumococcal conjugate vaccine is recommended at 12-15 months of life as per national immunization schedule: Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry.

Exclusion criteria

Exclusion Criteria:

Medical Conditions

  • History of any reaction or likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
  • Any confirmed or suspected 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.
  • History of varicella.
  • Recurrent history of or uncontrolled neurological disorders or seizures.
  • Participant with history of SARS-CoV-2 infection who is still symptomatic.
  • 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 and Concomitant Therapy

  • Use of any or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For , this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
  • Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.

Medical Conditions

  • 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.
  • History of varicella.
  • Recurrent history of or uncontrolled neurological disorders or seizures.
  • Participant with history of SARS-CoV-2 infection who is still symptomatic.
  • 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 and Concomitant Therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
  • Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.
  • Previous administration of a booster dose of any pneumococcal conjugate vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3) with the exception of inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions.

  • Any other age appropriate vaccine may be given starting at Visit 3 and anytime thereafter.

    • In case of emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor/designee is notified accordingly.

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 Exclusions

  • 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.
    • Pregnant women without documented history of varicella.
    • Newborn infants of mothers without documented history of varicella.
    • Newborn infants born \<28 weeks of gestation.
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
800 participants (actual)

Study arms

  • Experimental
    VNS_Low Group

    Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.

    Biological: Investigational varicella vaccine low potency · Biological: Measles, mumps, and rubella vaccine · Biological: Hepatitis A vaccine · Biological: 13-valent pneumococcal conjugate vaccine

  • Experimental
    VNS_Med Group

    Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Biological: Investigational varicella vaccine medium potency · Biological: Measles, mumps, and rubella vaccine · Biological: Hepatitis A vaccine · Biological: 13-valent pneumococcal conjugate vaccine

  • Experimental
    VNS_High Group

    Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Biological: Investigational varicella vaccine high potency · Biological: Measles, mumps, and rubella vaccine · Biological: Hepatitis A vaccine · Biological: 13-valent pneumococcal conjugate vaccine

  • Active comparator
    VV_Lot1 and Lot2 Pooled Group

    Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.

    Biological: Licensed varicella vaccine Lot 1 · Biological: Licensed varicella vaccine Lot 2 · Biological: Measles, mumps, and rubella vaccine · Biological: Hepatitis A vaccine · Biological: 13-valent pneumococcal conjugate vaccine

Interventions

  • BiologicalInvestigational varicella vaccine low potency

    1 dose of a low-potency investigational varicella vaccine administered subcutaneously.

  • BiologicalInvestigational varicella vaccine medium potency

    1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.

  • BiologicalInvestigational varicella vaccine high potency

    1 dose of a high-potency investigational varicella vaccine administered subcutaneously.

  • BiologicalLicensed varicella vaccine Lot 1

    1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.

  • BiologicalLicensed varicella vaccine Lot 2

    1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.

  • BiologicalMeasles, mumps, and rubella vaccine

    Drug page: Measles-Mumps-Rubella Vaccine

    1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.

  • BiologicalHepatitis A vaccine

    1 dose of a hepatitis A vaccine administered intramuscularly.

  • Biological13-valent pneumococcal conjugate vaccine

    1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.

06

What researchers measure

Primary outcomes

  1. Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies

    Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.

    Time frame: At Day 43

Secondary outcomes

  1. Percentage of Participants With Seroresponse to VZV gE

    Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL for each group.

    Time frame: At Day 43

  2. Number of Participants Reporting Each Solicited Administration Site Events

    Assessed solicited administration site events included injection site redness, pain and swelling.

    Time frame: Day 1 (post dose) to Day 4

  3. Number of Participants Reporting Each Solicited Systemic Events

    Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature \>= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash.

    Time frame: Day 1 (post dose) to Day 43

  4. Number of Participants Reporting Each Solicited Systemic Events

    Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.

    Time frame: Day 1 (post dose) to Day 15

  5. Number of Participants Reporting Unsolicited Adverse Events

    Unsolicited adverse events (AEs) included 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; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs.

    Time frame: Day 1 (post dose) to Day 43

  6. Number of Participants Reporting Serious Adverse Events (SAEs)

    A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment.

    Time frame: From Day 1 to Day 181 (Study end)

07

Results

Posted Feb 28, 2025

Participant flow

Out of 800 participants enrolled, 9 participants discontinued before receiving the vaccination and therefore only 791 participants were included in the Exposed Set and started the study.

Participant flow — Overall Study
MilestoneVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Started203195203190
Completed197190193185
Not completed65105
Withdrew: Lost to follow-up6373
Withdrew: Withdrawal by subject0231
Withdrew: Other0001

Outcome measures

PrimaryConcentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies

Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.

Time frame:
At Day 43
Reported as:
Geometric mean · mlU/ml
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies
mlU/mlVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies960 (843 to 1093)1071 (952 to 1204)1555 (1407 to 1718)1284 (1136 to 1453)
SecondaryPercentage of Participants With Seroresponse to VZV gE

Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL for each group.

Time frame:
At Day 43
Reported as:
Number · Percentage of participants
Percentage of Participants With Seroresponse to VZV gE
Percentage of participantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Percentage of Participants With Seroresponse to VZV gE93.6 (88.78 to 96.75)96.2 (91.97 to 98.60)98.7 (95.50 to 99.85)98.1 (94.65 to 99.61)
SecondaryNumber of Participants Reporting Each Solicited Administration Site Events

Assessed solicited administration site events included injection site redness, pain and swelling.

Time frame:
Day 1 (post dose) to Day 4
Reported as:
Count of participants · Participants
Number of Participants Reporting Each Solicited Administration Site Events
ParticipantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Injection site pain76647057
Redness at injection site24233523
Swelling at injection site14111512
SecondaryNumber of Participants Reporting Each Solicited Systemic Events

Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature \>= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash.

Time frame:
Day 1 (post dose) to Day 43
Reported as:
Count of participants · Participants
Number of Participants Reporting Each Solicited Systemic Events
ParticipantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Fever49485944
Any varicella-like rash33313529
Any general rash66516859
SecondaryNumber of Participants Reporting Each Solicited Systemic Events

Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.

Time frame:
Day 1 (post dose) to Day 15
Reported as:
Count of participants · Participants
Number of Participants Reporting Each Solicited Systemic Events
ParticipantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Any drowsiness86689380
Any loss of appetite69577160
Any irritability11294112109
SecondaryNumber of Participants Reporting Unsolicited Adverse Events

Unsolicited adverse events (AEs) included 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; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs.

Time frame:
Day 1 (post dose) to Day 43
Reported as:
Count of participants · Participants
Number of Participants Reporting Unsolicited Adverse Events
ParticipantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Number of Participants Reporting Unsolicited Adverse Events67536461
SecondaryNumber of Participants Reporting Serious Adverse Events (SAEs)

A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment.

Time frame:
From Day 1 to Day 181 (Study end)
Reported as:
Count of participants · Participants
Number of Participants Reporting Serious Adverse Events (SAEs)
ParticipantsVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
Number of Participants Reporting Serious Adverse Events (SAEs)2446

Adverse events

Collected over SAEs were collected from Day 1 to Day 181 (Study end), solicited administration site events from Day 1 to Day 4, solicited systemic events (drowsiness, loss of appetite and irritability) from Day 1 to Day 15, solicited systemic events and unsolicited AEs (fever, varicella-like rash [including injection site varicella like rash] and general rash [not varicella-like]) from Day 1 to Day 43. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VNS_Low Group0/203 (0%)2/203 (1%)173/203 (85.2%)
VNS_Med Group0/195 (0%)4/195 (2.1%)165/195 (84.6%)
VNS_High Group0/203 (0%)4/203 (2%)178/203 (87.7%)
VV_Lot1 and Lot2 Pooled Group0/190 (0%)6/190 (3.2%)158/190 (83.2%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
BronchiolitisInfections and infestations0/2030/1950/2032/190
Respiratory syncytial virus bronchiolitisInfections and infestations0/2032/1950/2031/190
Adenovirus infectionInfections and infestations0/2030/1950/2031/190
Croup infectiousInfections and infestations0/2030/1950/2031/190
Respiratory syncytial virus infectionInfections and infestations1/2030/1951/2031/190
DehydrationMetabolism and nutrition disorders0/2030/1950/2031/190
HypoxiaRespiratory, thoracic and mediastinal disorders0/2030/1950/2031/190
Viral infectionInfections and infestations0/2031/1950/2030/190
DyskinesiaNervous system disorders0/2031/1950/2030/190
InfluenzaInfections and infestations0/2030/1951/2030/190
Most frequent other events
Showing 10 of 107
Most frequent other events
EventVNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled Group
IrritabilityPsychiatric disorders113/20394/195112/203110/190
SomnolenceNervous system disorders87/20368/19593/20380/190
Rashes, eruptions and exanthems NECSkin and subcutaneous tissue disorders76/20364/19575/20372/190
Administration site painGeneral disorders76/20365/19570/20357/190
Decreased appetiteMetabolism and nutrition disorders71/20357/19571/20360/190
PyrexiaGeneral disorders49/20348/19559/20344/190
Administration site erythemaGeneral disorders24/20323/19535/20323/190
Administration site swellingGeneral disorders14/20311/19515/20312/190
Upper respiratory tract infectionInfections and infestations11/2036/19513/20310/190
NasopharyngitisInfections and infestations2/2033/1954/2039/190

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)VNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled GroupTotal
<=18 years203195203190791
Between 18 and 65 years00000
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)VNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled GroupTotal
Female114102101107424
Male899310283367
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)VNS_Low GroupVNS_Med GroupVNS_High GroupVV_Lot1 and Lot2 Pooled GroupTotal
Hispanic or Latino75717473293
Not Hispanic nor Latino128124128117497
Missing00101
08

Study locations

51 sites
  • GSK Investigational Site
    Bryant, Arkansas 72022, United States
  • GSK Investigational Site
    Jonesboro, Arkansas 72401, United States
  • GSK Investigational Site
    Little Rock, Arkansas 72202, United States
  • GSK Investigational Site
    Bellflower, California 90706, United States
  • GSK Investigational Site
    Downey, California 90240, United States
  • GSK Investigational Site
    Foothill Ranch, California 92610, United States
  • GSK Investigational Site
    Huntington Park, California 90255, United States
  • GSK Investigational Site
    Los Angeles, California 90057, United States
  • GSK Investigational Site
    West Covina, California 91790, United States
  • GSK Investigational Site
    Tampa, Florida 33613, United States
  • GSK Investigational Site
    Atlanta, Georgia 30310, United States
  • GSK Investigational Site
    Idaho Falls, Idaho 83404, United States
  • GSK Investigational Site
    New Orleans, Louisiana 70006-5322, United States
  • GSK Investigational Site
    Gulfport, Mississippi 39507, United States
  • GSK Investigational Site
    Bridgeton, Missouri 63044, United States
  • GSK Investigational Site
    Omaha, Nebraska 68134, United States
  • GSK Investigational Site
    Omaha, Nebraska 68198, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89128, United States
  • GSK Investigational Site
    Bronx, New York 10468, United States
  • GSK Investigational Site
    East Syracuse, New York 13210, United States
  • GSK Investigational Site
    Charlotte, North Carolina 28203, United States
  • GSK Investigational Site
    Cleveland, Ohio 44121, United States
  • GSK Investigational Site
    Dayton, Ohio 45406, United States
  • GSK Investigational Site
    Fort Washington, Pennsylvania 19034, United States
  • GSK Investigational Site
    Barnwell, South Carolina 29812, United States
  • GSK Investigational Site
    Tullahoma, Tennessee 37388, United States
  • GSK Investigational Site
    Corpus Christi, Texas 78414, United States
  • GSK Investigational Site
    Dallas, Texas 75230-2571, United States
  • GSK Investigational Site
    Dickinson, Texas 77539, United States
  • GSK Investigational Site
    Houston, Texas 77087, United States
  • GSK Investigational Site
    McAllen, Texas 78504, United States
  • GSK Investigational Site
    Pflugerville, Texas 78660, United States
  • GSK Investigational Site
    San Antonio, Texas 78218, United States
  • GSK Investigational Site
    Layton, Utah 84041, United States
  • GSK Investigational Site
    Provo, Utah 84604, United States
  • GSK Investigational Site
    Roy, Utah 84067, United States
  • GSK Investigational Site
    Saint George, Utah 84790, United States
  • GSK Investigational Site
    South Jordan, Utah 84095, United States
  • GSK Investigational Site
    Syracuse, Utah 84075, United States
  • GSK Investigational Site
    Charlottesville, Virginia 22902, United States
  • GSK Investigational Site
    Marshfield, Wisconsin 54449, United States
  • GSK Investigational Site
    Tallinn, 10617, Estonia
  • GSK Investigational Site
    Tartu, 50106, Estonia
  • GSK Investigational Site
    Bydgoszcz, 85-048, Poland
  • GSK Investigational Site
    Torun, 87-100, Poland
  • GSK Investigational Site
    San Juan, 00907, Puerto Rico
  • GSK Investigational Site
    San Juan, 00918, Puerto Rico
  • GSK Investigational Site
    Taichung, 40447, Taiwan
  • GSK Investigational Site
    Taipei, 10002, Taiwan
  • GSK Investigational Site
    Taoyuan, 333, Taiwan
  • GSK Investigational Site
    Ohio, 45414, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2022 to primary completion in Feb 2024, 24 months.

Results were first posted in Feb 2025, 1 year after primary completion.

Of 17 phase 2 interventional studies under Chickenpox, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2021
First posted
Oct 19, 2021
StartActual
Feb 3, 2022
Primary completionActual
Feb 9, 2024
CompletionActual
Jun 13, 2024
Results first posted
Feb 28, 2025
Last update
Feb 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05084508
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 19, 2021
Start date
Feb 3, 2022
Primary completion
Feb 9, 2024
Completion
Jun 13, 2024
Results posted
Feb 28, 2025
Last update
Feb 28, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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