A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

NCT06740630
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,840
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Lead sponsor
GlaxoSmithKline
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Start date
2025-01-10
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Number of sites
97
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Summary
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.
clinicaltrials.gov
Short title
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
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Official title
A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-05-17
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First posted
2024-12-18
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Registry last updated
2026-05-29
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Primary completion date
2026-12-25
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Start date
2025-01-10
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Participants
1,840
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Participant count basis
Estimated
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Planned participants
1,840
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Protocol amendments
0
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Number of sites
97
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06740630
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ClinicalTrials.gov ID
NCT06740630
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masking description
Observer-blind study.
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups

    Timeframe: At Day 43

    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.

  2. Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups

    Timeframe: At Day 43

    Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.

  3. 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

    Timeframe: At Day 43

    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.

  4. GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

    Timeframe: At Day 43

    Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.

  1. Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

    Timeframe: At Day 43

  2. Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

    Timeframe: At Day 43

  3. Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups

    Timeframe: At Day 43

  4. 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

    Timeframe: At Day 43

    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.

  5. 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

    Timeframe: At Day 43

    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.

  6. 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

    Timeframe: At Day 43

    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.

  7. 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

    Timeframe: At Day 43

  8. 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

    Timeframe: At Day 43

    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.

  9. 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

    Timeframe: At Day 43

    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.

  10. Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold

    Timeframe: At Day 43

    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.

  11. Percentage of participants reporting each solicited administration site event

    Timeframe: Day 1 (post-dose) to Day 4

    Solicited administration site events include injection site redness, pain and swelling.

  12. Percentage of participants reporting each solicited systemic event

    Timeframe: Day 1 (post-dose) to Day 15

    Solicited systemic events include drowsiness, loss of appetite and irritability.

  13. Percentage of participants reporting each solicited systemic event in terms of fever

    Timeframe: Day 1 (post-dose) to Day 22

    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).

  14. Percentage of participants reporting each solicited administration site event

    Timeframe: Day 1 (post-dose) to Day 43

    Solicited administration site events include injection site varicella-like rash.

  15. Percentage of participants reporting each solicited systemic event

    Timeframe: Day 1 (post-dose) to Day 43

    Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like).

  16. Percentage of participants reporting unsolicited adverse events (AEs)

    Timeframe: Day 1 (post-dose) to Day 43

    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.

  17. Percentage of participants reporting medically attended AEs (MAAE)

    Timeframe: Day 1 (post-dose) to Day 181 (study end)

    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.

  18. Percentage of participants reporting serious adverse events (SAEs)

    Timeframe: Day 1 (post-dose) to Day 181 (study end)

    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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
12 Months
Maximum age
15 Months
Healthy volunteers
Yes

  • Participant's parent(s) Legally acceptable representatives /(LAR[s]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).

  • 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 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.

  • 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.
  • 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 dose of study interventions administration (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 dose and ending 43 days after the dose of study interventions administration* (Visit 2) 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.

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.

    • 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 vaccines, e.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.
    • Pregnant women without documented history of varicella.
    • Newborn infants of mothers without documented history of varicella.
    • Newborn infants born less than (<) 28 weeks of gestation.
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteMobile, United StatesRecruiting
  • GSK Investigational SiteHot Springs, United StatesRecruiting
  • GSK Investigational SiteSherwood, United StatesRecruiting
  • GSK Investigational SiteCanoga Park, United StatesRecruiting
  • GSK Investigational SiteCovina, United StatesRecruiting
  • GSK Investigational SiteFullerton, United StatesWithdrawn
  • GSK Investigational SiteLong Beach, United StatesWithdrawn
  • GSK Investigational SiteLos Angeles, United StatesRecruiting
  • GSK Investigational SiteParamount, United StatesWithdrawn
  • GSK Investigational SiteSacramento, United StatesRecruiting
  • GSK Investigational SiteVentura, United StatesRecruiting
  • GSK Investigational SiteWalnut Creek, United StatesRecruiting
  • GSK Investigational SiteWinnetka, United StatesRecruiting
  • GSK Investigational SiteMiami, United StatesWithdrawn
  • GSK Investigational SiteMiami, United StatesRecruiting
  • GSK Investigational SiteMiami Lakes, United StatesRecruiting
  • GSK Investigational SiteSpring Hill, United StatesRecruiting
  • GSK Investigational SiteTampa, United StatesRecruiting
  • GSK Investigational SiteCovington, United StatesRecruiting
  • GSK Investigational SiteAmmon, United StatesRecruiting
  • GSK Investigational SiteMoline, United StatesRecruiting
  • GSK Investigational SiteSouth Bend, United StatesRecruiting
  • GSK Investigational SiteTopeka, United StatesRecruiting
  • GSK Investigational SiteBardstown, United StatesRecruiting
  • GSK Investigational SiteLouisville, United StatesRecruiting

And 72 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-515869-33-00
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (1)