A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

Официальное название

A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age

Обзор

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Вмешательства

• Биопрепарат Candidate varicella vaccine
  Investigational varicella vaccine administered intramuscularly.
• Биопрепарат Marketed varicella vaccine
  Marketed varicella vaccine administered subcutaneously.
• Биопрепарат MMR vaccine
  MMR vaccine administered subcutaneously or intramuscularly.
• Биопрепарат Hepatitis A vaccine
  Hepatitis A vaccine co-administered intramuscularly.
• Биопрепарат 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.
• Биопрепарат 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.
• Биопрепарат Vaxneuvance
  The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

Первичные конечные точки

• Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) [Срок оценки: At Day 43]
• Geometric Mean Concentration (GMC) of anti-VZV gE IgG [Срок оценки: At Day 43]
• Percentage of participants with seroresponse to MMR antigens [Срок оценки: At Day 43]
• GMC of Anti-measles antibodies [Срок оценки: At Day 43]
• GMC of Anti-mumps antibodies [Срок оценки: At Day 43]
• GMC of Anti-rubella antibodies [Срок оценки: At Day 43]

Вторичные конечные точки (11)

• Percentage of participants with seroresponse to demonstrate an acceptable immune response for IM administration of MMR vaccine [Срок оценки: At Day 43]
• Percentage of participants with seroresponse to MMR antigens with a reduced non-inferiority margin [Срок оценки: At Day 43]
• Percentage of participants reporting each solicited administration site events post-dose of investigational VNS vaccine or VV administration [Срок оценки: Day 1 (post-dose) to Day 4]
• Percentage of participants reporting each solicited administration site events post-dose of MMR vaccine administration [Срок оценки: Day 1 (post-dose) to Day 4]
• Percentage of participants reporting each solicited systemic events post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 15]
• Percentage of participants reporting each solicited systemic event in terms of fever post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 22]
• Percentage of participants reporting each solicited administration site events post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 43]
• Percentage of participants reporting each solicited systemic events post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 43]
• Percentage of participants reporting unsolicited Adverse Events (AEs) post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 43]
• Percentage of participants reporting medically attended AEs (MAAE) post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 181 (Study end)]
• Percentage of participants reporting Serious AEs (SAEs) post-dose of study interventions administration [Срок оценки: Day 1 (post-dose) to Day 181 (Study end)]

Критерии участия

Критерии включения

• 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 the administration of study intervention.

Критерии исключения

• 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.
• Recurrent history of uncontrolled neurological disorders or seizures.
• History of measles, mumps, rubella, or varicella disease.
• Active untreated tuberculosis.
• Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).
• Condition that in the judgment of the investigator would make intramuscular injection unsafe.
• 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/Concomitant therapy

• 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.
• 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 varicella virus.
• Previous vaccination against hepatitis A 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.

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 exclusion criteria

• Any study personnel or their immediate dependents, family, or household members.
• Child in care.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 13 центров

• GSK Investigational Site — Tucson
• GSK Investigational Site — Huntington Park
• GSK Investigational Site — Sherman Oaks
• GSK Investigational Site — Coral Gables
• GSK Investigational Site — Miami Lakes
• GSK Investigational Site — Tampa
• GSK Investigational Site — Idaho Falls
• GSK Investigational Site — Dayton
• … и ещё 5 центров

Греция · 3 центра

• GSK Investigational Site — Athens
• GSK Investigational Site — Athens
• GSK Investigational Site — Thessaloniki

Румыния · 2 центра

• GSK Investigational Site — Brasov
• GSK Investigational Site — Calarasi

Бельгия · 1 центр

• GSK Investigational Site — Alken

Эстония · 1 центр

• GSK Investigational Site — Tartu

Польша · 1 центр

• GSK Investigational Site — Trzebnica

Таиланд · 1 центр

• GSK Investigational Site — Chiang Mai

Идентификаторы

NCT: NCT06855160 · 223105 · 2024-518840-18-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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