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
NCT ID: NCT05084508
Last Updated: 2025-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
800 participants
INTERVENTIONAL
2022-02-03
2024-06-13
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Investigational varicella vaccine low potency
1 dose of a low-potency investigational varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly.
13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
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.
Investigational varicella vaccine medium potency
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly.
13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
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.
Investigational varicella vaccine high potency
1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly.
13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
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.
Licensed varicella vaccine Lot 1
1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.
Licensed varicella vaccine Lot 2
1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly.
13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
Interventions
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Investigational varicella vaccine low potency
1 dose of a low-potency investigational varicella vaccine administered subcutaneously.
Investigational varicella vaccine medium potency
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
Investigational varicella vaccine high potency
1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
Licensed varicella vaccine Lot 1
1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.
Licensed varicella vaccine Lot 2
1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
Hepatitis A vaccine
1 dose of a hepatitis A vaccine administered intramuscularly.
13-valent pneumococcal conjugate vaccine
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Months
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Bryant, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Bellflower, California, United States
GSK Investigational Site
Downey, California, United States
GSK Investigational Site
Foothill Ranch, California, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Idaho Falls, Idaho, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Gulfport, Mississippi, United States
GSK Investigational Site
Bridgeton, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
East Syracuse, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Fort Washington, Pennsylvania, United States
GSK Investigational Site
Barnwell, South Carolina, United States
GSK Investigational Site
Tullahoma, Tennessee, United States
GSK Investigational Site
Corpus Christi, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dickinson, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Pflugerville, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
St. George, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Marshfield, Wisconsin, United States
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Torun, , Poland
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
San Juan, , Puerto Rico
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taoyuan District, , Taiwan
GSK Investigational Site
Ohio, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-001910-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
217212
Identifier Type: -
Identifier Source: org_study_id
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