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Идёт набор NCT07300267

A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Фаза I С лечением Pneumococcal Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: V118C (Stage 1), V118C (Stage 2), PCV20 (Stage 1), PCV20 (Stage 2).
Кому может быть актуально
Состояния в реестре: Pneumococcal Infection. Базовые параметры: 2 мес. — 15 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children

Обзор

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria. This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

Подробное описание

Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).

Вмешательства

  • Биопрепарат V118C (Stage 1)
    IM administration of V118C
  • Биопрепарат V118C (Stage 2)
    IM administration of V118C
  • Биопрепарат PCV20 (Stage 1)
    IM administration of PCV20
  • Биопрепарат PCV20 (Stage 2)
    IM administration of PCV20

Первичные конечные точки

  • Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination [Срок оценки: Up to approximately 30 minutes postvaccination]
  • Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) [Срок оценки: Up to approximately 7 days postvaccination]
  • Stage 1: Percentage of Participants With Solicited Systemic AEs [Срок оценки: Up to approximately 7 days postvaccination]
  • Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [Срок оценки: Up to approximately 28 days postvaccination]
  • Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 12 months postvaccination]
  • Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs) [Срок оценки: Up to approximately 12 months postvaccination]
  • Stage 2: Percentage of Participants With Immediate AEs Following Vaccination [Срок оценки: Up to approximately 30 minutes after each vaccination]
  • Stage 2: Percentage of Participants With Solicited Injection-Site AEs [Срок оценки: Up to approximately 7 days after each vaccination]
  • Stage 2: Percentage of Participants With Solicited Systemic AEs [Срок оценки: Up to approximately 7 days after each vaccination]
  • Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs [Срок оценки: Up to approximately 28 days after each vaccination]
Вторичные конечные точки (12)
  • Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG) [Срок оценки: Up to approximately 30 days post vaccination]
  • Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20] [Срок оценки: Approximately Day 30 postvaccination]
  • Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG) [Срок оценки: Day 1 (Baseline) and approximately Day 30 postvaccination]
  • Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations [Срок оценки: Day 1 (Baseline) and approximately Day 30 postvaccination]
  • Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3 [Срок оценки: Up to approximately 30 days postdose 3]
  • Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4 [Срок оценки: Up to approximately 6 months post dose 3]
  • Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4 [Срок оценки: Up to approximately 30 days postdose 4]
  • Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3 [Срок оценки: Up to approximately 30 days postdose 3]
  • Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4 [Срок оценки: Up to approximately 30 days postdose 4]
  • Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3 [Срок оценки: Up to approximately 30 days postdose 3]
  • Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4 [Срок оценки: Up to approximately 6 months post dose 3]
  • Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4 [Срок оценки: Up to approximately 30 days postdose 4]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Stage 1:

  • Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
  • Is 12 through 15 months of age

Stage 2:

\- Is approximately 2 months of age

Both Stages:

  • Was born at full term (gestational age greater than or equal to 37 weeks)

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Stage 1:

\- Has received a PCV dose at 10 months of age and older

Stage 2:

  • Has received prior administration of any pneumococcal vaccine

Both stages:

  • Has a history of invasive pneumococcal disease (IPD)
  • Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 14 центров
  • Madera Family Medical Group ( Site 1004) — Madera
  • Acevedo Clinical Research Associates ( Site 1029) — Miami
  • University of South Florida-Department of Pediatrics ( Site 1002) — Tampa
  • Cotton O'Neil Research Center ( Site 1039) — Topeka
  • University of Louisville, Norton Children's Research Institute ( Site 1005) — Louisville
  • The Pediatric Center ( Site 1025) — Columbia
  • Saint Louis University Center for Vaccine Development ( Site 1031) — St Louis
  • Child Health Care Associates ( Site 1035) — East Syracuse
  • … и ещё 6 центров

Идентификаторы

NCT: NCT07300267 · V118C-002

Первоисточники (государственные реестры)

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