A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age

NCT06693895 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2139972024-515868-31-00
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Conditions

Chickenpox

Keywords

Chickenpox; Investigational varicella vaccine (VNS) Varicella

Outcome Measures

Primary Outcomes (8)

• Percentage of participants reporting each solicited administration site events

  Solicited administration site events include injection site redness, pain and swelling.

  Day 1 (post-dose) to Day 4

• Percentage of participants reporting each solicited systemic event

  Solicited systemic events include drowsiness, loss of appetite and irritability.

  Day 1 (post-dose) to Day 15

• Percentage of participants reporting each solicited systemic event in terms of fever

  Fever is defined as temperature greater than or equal to (\>=) 38.0°C (100.4°F) by any route (the preferred location for measuring temperature is the axilla).

  Day 1 (post-dose) to Day 22

• Percentage of participants reporting each solicited administration site events

  Solicited administration site include injection site varicella-like rash.

  Day 1 (post-dose) to Day 43

• Percentage of participants reporting solicited systemic events

  Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).

  Day 1 (post-dose) to Day 43

• Percentage of participants reporting unsolicited adverse events (AEs)

  An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  Day 1 (post-dose) to Day 43

• Percentage of participants reporting medically attended AEs (MAAE)

  A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.

  Day 1 (post-dose) to Day 181 (study end)

• Percentage of participants reporting serious adverse events (SAEs)

  A SAE is an AE which results in death, 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.

  Day 1 (post-dose) to Day 181 (study end)

Study Arms (2)

VNS Group

EXPERIMENTAL

Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Biological: Investigational varicella vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: PCV (pneumococcal conjugate vaccine) 13; Biological: PCV 20; Biological: Vaxneuvance

VV Group

ACTIVE COMPARATOR

Participants receive 1 dose of a marketed VV, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.

Biological: Marketed varicella vaccine; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: PCV (pneumococcal conjugate vaccine) 13; Biological: PCV 20; Biological: Vaxneuvance

Interventions

Investigational varicella vaccine BIOLOGICAL

1 dose of investigational varicella vaccine administered subcutaneously.

VNS Group

Marketed varicella vaccine BIOLOGICAL

1 dose of marketed varicella vaccine administered subcutaneously.

VV Group

Measles, mumps, and rubella vaccine BIOLOGICAL

1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

VNS Group; VV Group

Hepatitis A vaccine BIOLOGICAL

1 dose of hepatitis A vaccine co-administered intramuscularly.

VNS Group; VV Group

PCV (pneumococcal conjugate vaccine) 13 BIOLOGICAL

1 dose of 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.

VNS Group; VV Group

PCV 20 BIOLOGICAL

1 dose of 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.

VNS Group; VV Group

Vaxneuvance BIOLOGICAL

1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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.

VNS Group; VV Group

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 (no laboratory testing required).
• Hypersensitivity to latex.
• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

West Covina, California, 91790, United States

RECRUITING

MeSH Terms

Conditions

Chickenpox

Interventions

Measles-Mumps-Rubella Vaccine; Hepatitis A Vaccines; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine; Viral Hepatitis Vaccines; Streptococcal Vaccines; Bacterial Vaccines

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Observer-blind study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 23, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

US (1)