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
Overview
- Phase
- Phase 2
- Intervention
- Investigational varicella vaccine low potency
- Conditions
- Chickenpox
- Sponsor
- GlaxoSmithKline
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies
- Status
- Completed
- Last Updated
- last year
Overview
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.
Detailed Description
The study aims to demonstrate the immunogenicity of the investigational VNS vaccine at three potencies (VNS_Low, VNS_Med, and VNS_High) compared to the licensed varicella vaccine, Varivax (VV), as a first dose for children aged 12 to 15 months in the US. To ensure more representative data, participants in the VV group are randomized into two lots (VV_Lot1 and VV_Lot2), which are analyzed as pooled lots throughout the study. Besides assessing immunogenicity, the study also seeks to generate safety data. 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.
Investigators
Eligibility 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
Arms & Interventions
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.
Intervention: Investigational varicella vaccine low potency
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.
Intervention: Measles, mumps, and rubella vaccine
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.
Intervention: Hepatitis A vaccine
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.
Intervention: 13-valent pneumococcal conjugate vaccine
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.
Intervention: Investigational varicella vaccine medium potency
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.
Intervention: Measles, mumps, and rubella vaccine
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.
Intervention: Hepatitis A vaccine
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.
Intervention: 13-valent pneumococcal conjugate vaccine
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.
Intervention: Investigational varicella vaccine high potency
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.
Intervention: Measles, mumps, and rubella vaccine
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.
Intervention: Hepatitis A vaccine
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.
Intervention: 13-valent pneumococcal conjugate vaccine
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.
Intervention: Licensed varicella vaccine Lot 1
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.
Intervention: Licensed varicella vaccine Lot 2
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.
Intervention: Measles, mumps, and rubella vaccine
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.
Intervention: Hepatitis A vaccine
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.
Intervention: 13-valent pneumococcal conjugate vaccine
Outcomes
Primary Outcomes
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies
Time Frame: At Day 43
Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.
Secondary Outcomes
- Percentage of Participants With Seroresponse to VZV gE(At Day 43)
- Number of Participants Reporting Each Solicited Administration Site Events(Day 1 (post dose) to Day 4)
- Number of Participants Reporting Unsolicited Adverse Events(Day 1 (post dose) to Day 43)
- Number of Participants Reporting Each Solicited Systemic Events(Day 1 (post dose) to Day 15)
- Number of Participants Reporting Serious Adverse Events (SAEs)(From Day 1 to Day 181 (Study end))