Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age

Официальное название

A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age

Обзор

This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.

Вмешательства

• Биопрепарат LR20062
  DTaP-HepB-IPV-Hib vaccine
• Биопрепарат DTaP-HepB-IPV-Hib vaccine
  Control hexavalent vaccine

Первичные конечные точки

• Seroprotection/vaccine-response rate [Срок оценки: 1 month after the third dose primary series]

Вторичные конечные точки (6)

• Geometric mean concentration (GMC) or Geometric mean titer (GMT) [Срок оценки: 1 month after the third dose primary series]
• Seroconversion rate [Срок оценки: 1 month after the third dose primary series]
• Long-term seroprotection rate [Срок оценки: 1 month after the third dose primary series]
• Solicited adverse event [Срок оценки: 7 days after each vaccination]
• Unsolicited adverse event [Срок оценки: 1 month after each vaccinations]
• Immediate reactions after vaccination [Срок оценки: 30 minutes after each vaccination]

Критерии участия

Критерии включения

• Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
• Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.

Критерии исключения

Medical conditions:

• Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
• Has a known SARS-CoV-2 infection at Screening.
• Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
• Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
• Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \[≥100.4℉\] occurring at or within 72 hours prior to receipt of study vaccine.

Prior/concomitant therapy:

• Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
• Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
• Meets one or more of the following systemic corticosteroid exclusion criteria:

• Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.
• Is expected to require any systemic corticosteroids during conduct of the study.

Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.

• Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.

Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06618196 · LG-VGCL002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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