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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

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ClinicalTrials.gov Identifier: NCT05084508
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Chickenpox Biological: Investigational varicella vaccine low potency Biological: Investigational varicella vaccine medium potency Biological: Investigational varicella vaccine high potency Biological: Marketed varicella vaccine Lot 1 Biological: Marketed varicella vaccine Lot 2 Biological: Measles, mumps, and rubella vaccine Biological: Hepatitis A vaccine Biological: 13-valent pneumococcal conjugate vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Observer-blind study. Recipients and study evaluators will be unaware of vaccine administered.
Primary Purpose: Prevention
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
Actual Study Start Date : February 3, 2022
Estimated Primary Completion Date : October 2, 2023
Estimated Study Completion Date : March 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arm Intervention/treatment
Experimental: VNS_Low Group
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of low potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine and 1 dose of a13 valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Biological: Investigational varicella vaccine low potency
1 dose of a low-potency investigational varicella vaccine administered subcutaneously in the upper arm

Biological: Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm

Biological: Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly in the right anterolateral thigh

Biological: 13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the left anterolateral thigh

Experimental: VNS_Med Group
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of medium potency, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Biological: Investigational varicella vaccine medium potency
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm

Biological: Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm

Biological: Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly in the right anterolateral thigh

Biological: 13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the left anterolateral thigh

Experimental: VNS_High Group
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of high potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Biological: Investigational varicella vaccine high potency
1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm

Biological: Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm

Biological: Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly in the right anterolateral thigh

Biological: 13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the left anterolateral thigh

Active Comparator: VV_Lot1 and Lot2 Pooled Group
Healthy children aged 12 to 15 months of age receive 1 dose of a marketed varicella vaccine (VV) of Lot 1 or 1 dose of a marketed varicella vaccine (VV) of Lot 2, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and a 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Biological: Marketed varicella vaccine Lot 1
1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm

Biological: Marketed varicella vaccine Lot 2
1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm

Biological: Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm

Biological: Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly in the right anterolateral thigh

Biological: 13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the left anterolateral thigh




Primary Outcome Measures :
  1. Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies [ Time Frame: At Day 43 ]
    Concentrations of anti-VZV gE antibodies are presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.


Secondary Outcome Measures :
  1. Percentage of participants with seroresponse to VZV gE [ Time Frame: At Day 43 ]
    Seroresponse is defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration is greater than or equal to (≥) 300 milli-international units per milliliter (mIU/mL) for each group.

  2. Percentage of participants reporting solicited administration site events [ Time Frame: During the 4-day period after the administration of study interventions (administered at Day 1) ]
    Solicited administration site events include injection site redness, pain and swelling.

  3. Percentage of participants reporting solicited systemic events [ Time Frame: During the 43-day period after the administration of study interventions (administered at Day 1) ]

    Solicited systemic events include fever, varicella like rash, and general rash (not varicella-like) after the administration of all vaccines for each group.

    Fever is defined as temperature greater than or equal to (≥)38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route (the preferred location for measuring temperature is the axilla).

    A typical varicella-like rash manifests as a rash/lesions that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash


  4. Percentage of participants reporting solicited systemic events [ Time Frame: During the 15-day period after the administration of study interventions (administered at Day 1) ]
    Solicited systemic events include drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.

  5. Percentage of participants reporting unsolicited adverse events [ Time Frame: During the 43 days-period after the administration of study interventions (administrated at Day 1) ]
    Unsolicited adverse events (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.

  6. Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: Throughout the entire study period (From Day 1 to Day 181) ]
    A SAE is an AE which 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Exclusion Criteria:

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05084508


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT05084508    
Other Study ID Numbers: 217212
2022-001910-21 ( EudraCT Number )
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GlaxoSmithKline:
Varicella
Chickenpox
Additional relevant MeSH terms:
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Chickenpox
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs