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ChickenpoxPhase 2NCT05084508

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 study testing Investigational varicella vaccine low potency, Investigational varicella vaccine medium potency and Investigational varicella vaccine high potency in people with Chickenpox, run by GlaxoSmithKline at 51 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 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 low potency, Investigational varicella vaccine medium potency and Investigational varicella vaccine high potency
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
51 sitesin 6 countries
Study dates
3 Feb 2022to 13 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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 informed consent 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.

Who cannot join

  • 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.
Show all 44Show fewer
  • 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.
  • 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.

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

United States41 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30310

  • GSK Investigational Site

    Barnwell, South Carolina, 29812

  • GSK Investigational Site

    Bellflower, California, 90706

  • GSK Investigational Site

    Bridgeton, Missouri, 63044

  • GSK Investigational Site

    Bryant, Arkansas, 72022

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Corpus Christi, Texas, 78414

  • GSK Investigational Site

    Dallas, Texas, 75230-2571

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Dickinson, Texas, 77539

  • GSK Investigational Site

    Downey, California, 90240

  • GSK Investigational Site

    East Syracuse, New York, 13210

  • GSK Investigational Site

    Foothill Ranch, California, 92610

  • GSK Investigational Site

    Fort Washington, Pennsylvania, 19034

  • GSK Investigational Site

    Gulfport, Mississippi, 39507

  • GSK Investigational Site

    Houston, Texas, 77087

  • GSK Investigational Site

    Huntington Park, California, 90255

  • GSK Investigational Site

    Idaho Falls, Idaho, 83404

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Las Vegas, Nevada, 89128

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Little Rock, Arkansas, 72202

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    McAllen, Texas, 78504

  • GSK Investigational Site

    New Orleans, Louisiana, 70006-5322

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Pflugerville, Texas, 78660

  • GSK Investigational Site

    Provo, Utah, 84604

  • GSK Investigational Site

    Roy, Utah, 84067

  • GSK Investigational Site

    San Antonio, Texas, 78218

  • GSK Investigational Site

    South Jordan, Utah, 84095

  • GSK Investigational Site

    St. George, Utah, 84790

  • GSK Investigational Site

    Syracuse, Utah, 84075

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    The Bronx, New York, 10468

  • GSK Investigational Site

    Tullahoma, Tennessee, 37388

  • GSK Investigational Site

    West Covina, California, 91790

Other trials in United States

Taiwan3 sites

  • GSK Investigational Site

    Taichung, 40447

  • GSK Investigational Site

    Taipei, 10002

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 10617

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

Poland2 sites

  • GSK Investigational Site

    Bydgoszcz, 85-048

  • GSK Investigational Site

    Torun, 87-100

Other trials in Poland

Puerto Rico2 sites

  • GSK Investigational Site

    San Juan, 00907

  • GSK Investigational Site

    San Juan, 00918

Other trials in Puerto Rico

United Kingdom1 site

  • GSK Investigational Site

    Ohio, 45414

Other trials in United Kingdom

About this study

Official title: A Phase II, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Varicella Vaccine at Various Potencies Compared With Varivax, as a First Dose, Administered in Healthy Children in Their Second Year of Life

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.

Conditions
Chickenpox
Being tested
Investigational varicella vaccine low potency, Investigational varicella vaccine medium potency, Investigational varicella vaccine high potency, Licensed varicella vaccine Lot 1, Licensed varicella vaccine Lot 2
Keywords
Varicella, Chickenpox
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 vaccine low potencyBiological

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

  • Investigational varicella vaccine medium potencyBiological

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

  • Investigational varicella vaccine high potencyBiological

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

  • Licensed varicella vaccine Lot 1Biological

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

  • Licensed varicella vaccine Lot 2Biological

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

  • Measles, mumps, and rubella vaccineBiological

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

  • Hepatitis A vaccineBiological

    1 dose of a hepatitis A vaccine administered intramuscularly.

  • 13-valent pneumococcal conjugate vaccineBiological

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

Study groups in NCT05084508
Study groupRoleWhat they receive
VNS_Low GroupExperimentalParticipants 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.
Receives: Biological: Investigational varicella vaccine low potency; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: 13-valent pneumococcal conjugate vaccine
VNS_Med GroupExperimentalParticipants 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.
Receives: Biological: Investigational varicella vaccine medium potency; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: 13-valent pneumococcal conjugate vaccine
VNS_High GroupExperimentalParticipants 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.
Receives: Biological: Investigational varicella vaccine high potency; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: 13-valent pneumococcal conjugate vaccine
VV_Lot1 and Lot2 Pooled GroupActive comparatorParticipants 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Day 43

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From Day 1 to Day 181 (Study end)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2021
  2. Study start3 Feb 2022
  3. Primary completion9 Feb 2024
  4. Study completion13 Jun 2024

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05084508
Sponsor's protocol ID
217212
Other IDs
2022-001910-21
Status last verified
Feb 2025
First submitted
18 Oct 2021
Last updated
28 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Habib MA, Domachowske JB, Senders S, Korbal P, Gassama FD, Debrus S, Benedek P, Povey M, Poder A; VNS20-006 study group. Immunogenicity and safety of an investigational varicella zoster vaccine in toddlers aged 12-15 months: results of a phase II, controlled, randomized trial. Vaccine. 2026 Apr 19;79:128439. doi: 10.1016/j.vaccine.2026.128439. Epub 2026 Mar 12.

    PubMed 41825190

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational varicella vaccine low potency, Investigational varicella vaccine medium potency and Investigational varicella vaccine high potency in people with Chickenpox, run by GlaxoSmithKline at 51 sites in 6 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 44 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Taiwan, Estonia, Poland, Puerto Rico and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies (time frame: At Day 43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05084508, which also lists 1 linked publication.

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 28 Feb 2025.

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