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

Chickenpox Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05084508
• Other study ID #: 217212
• Secondary ID: 2022-001910-21
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 3, 2022
• Est. completion date: July 5, 2024

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: July 5, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox

Intervention

Biological:
• Investigational varicella vaccine low potency
1 dose of a low-potency investigational varicella vaccine administered subcutaneously in the upper arm
• Investigational varicella vaccine medium potency
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm
• Investigational varicella vaccine high potency
1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm
• Marketed varicella vaccine Lot 1
1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm
• Marketed varicella vaccine Lot 2
1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm
• Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm
• Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly in the right anterolateral thigh
• 13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the left anterolateral thigh

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Mexico	GSK Investigational Site	Tlalpan
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Tarnow
Poland	GSK Investigational Site	Torun
Puerto Rico	GSK Investigational Site	San Juan
Puerto Rico	GSK Investigational Site	San Juan
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Barnwell	South Carolina
United States	GSK Investigational Site	Bellflower	California
United States	GSK Investigational Site	Bridgeton	Missouri
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Bryant	Arkansas
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cheraw	South Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Dickinson	Texas
United States	GSK Investigational Site	Downey	California
United States	GSK Investigational Site	Edinburg	Texas
United States	GSK Investigational Site	Foothill Ranch	California
United States	GSK Investigational Site	Fort Washington	Pennsylvania
United States	GSK Investigational Site	Gardena	California
United States	GSK Investigational Site	Gulfport	Mississippi
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Lake Mary	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Marshfield	Wisconsin
United States	GSK Investigational Site	McAllen	Texas
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Nampa	Idaho
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pflugerville	Texas
United States	GSK Investigational Site	Provo	Utah
United States	GSK Investigational Site	Roy	Utah
United States	GSK Investigational Site	Saint George	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	South Jordan	Utah
United States	GSK Investigational Site	Syracuse	Utah
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tullahoma	Tennessee
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Webster	Texas
United States	GSK Investigational Site	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Estonia,  Mexico,  Poland,  Puerto Rico,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies	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.	At Day 43
Secondary	Percentage of participants with seroresponse to VZV gE	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.	At Day 43
Secondary	Percentage of participants reporting solicited administration site events	Solicited administration site events include injection site redness, pain and swelling.	During the 4-day period after the administration of study interventions (administered at Day 1)
Secondary	Percentage of participants reporting solicited systemic events	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	During the 43-day period after the administration of study interventions (administered at Day 1)
Secondary	Percentage of participants reporting solicited systemic events	Solicited systemic events include drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.	During the 15-day period after the administration of study interventions (administered at Day 1)
Secondary	Percentage of participants reporting unsolicited adverse events	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.	During the 43 days-period after the administration of study interventions (administrated at Day 1)
Secondary	Percentage of participants reporting serious adverse events (SAEs)	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.	Throughout the entire study period (From Day 1 to Day 181)