Recruiting
Phase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
Condition(s) studied
Chickenpox
Investigational drug(s) / intervention(s)
Investigational varicella vaccine_Lot 1Investigational varicella vaccine_Lot 2Investigational varicella vaccine_Lot 3Marketed varicella vaccine_Lot 1Marketed varicella vaccine_Lot 2MMR vaccine →Hepatitis A vaccinePCV (pneumococcal conjugate vaccine) 13PCV 20Vaxneuvance
Investigational varicella vaccine_Lot 1: Investigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine_Lot 2: Investigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine_Lot 3: Investigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine_Lot 1: Marketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine_Lot 2: Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine: MMR vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine: Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13: The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20: The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance: The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups — 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.
- Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups — At Day 43
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
- 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 — 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.
- GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups — At Day 43
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
Trial sites (97)
| Facility | City | Region | Status |
| GSK Investigational Site |
Mobile |
Alabama |
Recruiting |
| GSK Investigational Site |
Hot Springs |
Arkansas |
Recruiting |
| GSK Investigational Site |
Sherwood |
Arkansas |
Recruiting |
| GSK Investigational Site |
Canoga Park |
California |
Recruiting |
| GSK Investigational Site |
Covina |
California |
Recruiting |
| GSK Investigational Site |
Fullerton |
California |
Withdrawn |
| GSK Investigational Site |
Long Beach |
California |
Withdrawn |
| GSK Investigational Site |
Los Angeles |
California |
Recruiting |
| GSK Investigational Site |
Paramount |
California |
Withdrawn |
| GSK Investigational Site |
Sacramento |
California |
Recruiting |
| GSK Investigational Site |
Ventura |
California |
Recruiting |
| GSK Investigational Site |
Walnut Creek |
California |
Recruiting |
| GSK Investigational Site |
Winnetka |
California |
Recruiting |
| GSK Investigational Site |
Miami |
Florida |
Withdrawn |
| GSK Investigational Site |
Miami |
Florida |
Recruiting |
| GSK Investigational Site |
Miami Lakes |
Florida |
Recruiting |
| GSK Investigational Site |
Spring Hill |
Florida |
Recruiting |
| GSK Investigational Site |
Tampa |
Florida |
Recruiting |
| GSK Investigational Site |
Covington |
Georgia |
Recruiting |
| GSK Investigational Site |
Ammon |
Idaho |
Recruiting |
| GSK Investigational Site |
Moline |
Illinois |
Recruiting |
| GSK Investigational Site |
South Bend |
Indiana |
Recruiting |
| GSK Investigational Site |
Topeka |
Kansas |
Recruiting |
| GSK Investigational Site |
Bardstown |
Kentucky |
Recruiting |
| GSK Investigational Site |
Louisville |
Kentucky |
Recruiting |
| GSK Investigational Site |
Haughton |
Louisiana |
Recruiting |
| GSK Investigational Site |
Fall River |
Massachusetts |
Recruiting |
| GSK Investigational Site |
Bingham Farms |
Michigan |
Recruiting |
| GSK Investigational Site |
Jefferson City |
Missouri |
Recruiting |
| GSK Investigational Site |
Lincoln |
Nebraska |
Recruiting |
| GSK Investigational Site |
Lincoln |
Nebraska |
Withdrawn |
| GSK Investigational Site |
Lincoln |
Nebraska |
Recruiting |
| GSK Investigational Site |
The Bronx |
New York |
Recruiting |
| GSK Investigational Site |
Charlotte |
North Carolina |
Recruiting |
| GSK Investigational Site |
Monroe |
North Carolina |
Withdrawn |
| GSK Investigational Site |
Cleveland |
Ohio |
Recruiting |
| GSK Investigational Site |
Dayton |
Ohio |
Recruiting |
| GSK Investigational Site |
Chickasha |
Oklahoma |
Recruiting |
| GSK Investigational Site |
Tulsa |
Oklahoma |
Recruiting |
| GSK Investigational Site |
Gresham |
Oregon |
Recruiting |
+ 57 more sites — see the full list on the official registry below.
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