Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)

Официальное название

A Phase III, Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Administered as a Series of 2 Infant Doses and 1 Toddler Dose in Healthy Infants

Обзор

A Phase III clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in infants aged approximately 2 months (42 to 89 days). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind, active controlled phase III clinical trial.

Подробное описание

A phase III clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Philippines infants aged approximately 2 months (42 to 89 days).

The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar 13™ manufactured by Pfizer.

About 500 infants aged approximately 2 months (42 to 89 days) will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.

Вмешательства

• Биопрепарат Sinovac PCV13
  One dose of Sinovac PCV13 (0.5ml) was administered at 2, 4, and 12-15 months of age.
• Биопрепарат Prevenar 13™
  One dose of Prevenar 13™ (0.5ml) was administered at 2, 4, and 12-15 months of age.

Первичные конечные точки

• Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL . [Срок оценки: 30 days after dose 2.]
• Geometric mean concentrations (GMCs) of serotype-specific IgG antibody. [Срок оценки: 30 days after dose 2]

Вторичные конечные точки (12)

• Percentage of participants with pneumococcal serotype-specific IgG antibody concentrations≥0.35 μg/mL . [Срок оценки: 30 days after dose 3.]
• Geometric mean concentrations (GMCs ) of serotype-specific IgG antibody. [Срок оценки: 30 days after dose 3.]
• Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL [Срок оценки: 30 days after dose 2]
• Percentage of participants with serotype-specific IgG concentrations ≥ 1.0 μg/mL . [Срок оценки: 30 days after dose 3]
• GMC fold increases (GMFRs) in IgG antibody concentrations. [Срок оценки: From before dose 3 to 30 days after dose 3]
• Percentage of participants with serotype-specific opsonophagocytosis assay (OPA) antibody titers ≥1:8 [Срок оценки: 30 days after the dose 2.]
• Percentage of participants with serotype-specific OPA antibody titers ≥1:8. [Срок оценки: 30 days after the dose 3.]
• Geometric mean titers (GMTs) of serotype-specific OPA antibody. [Срок оценки: 30 days after dose 2.]
• GMTs of serotype-specific OPA antibody . [Срок оценки: 30 days after dose 3.]
• GMT fold rises (GMFRs) in OPA titers. [Срок оценки: From before dose 3 to 30 days after dose 3.]
• Incidence of adverse reactions [Срок оценки: 0-30 days after each dose.]
• Incidence of adverse reactions [Срок оценки: 0-7 days after each dose]

Критерии участия

Критерии включения

• Health infants aged approximately 2 months (42 to 89 days)
• Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
• Be able to provide the vaccination records since birth.
• The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided).

Критерии исключения

• Previous vaccination of any licensed or investigational pneumococcal vaccine, or planned receipt during the study participation;
• Previous vaccination of vaccines containing the component of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
• Previous receipt of ≥2 doses of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old.
• History of severe adverse reaction to previous vaccinations and/or serious allergic reactions (eg, anaphylaxis) to any vaccine component.
• History of any laboratory confirmed pneumococcal bacterial pneumonia or invasive pneumococcal diseases caused by S pneumoniae.
• Premature infants (born before week 37 of gestation).
• Severe congenital malformations, developmental disorders, clinically significant genetic defects, malnutrition.
• Autoimmune diseases or immunodeficiency/immunosuppression.
• Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
• Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
• Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
• Received blood products before investigational vaccine inoculation, or plan to receive these treatments during study participation.
• Received other investigational drugs/vaccines before enrollment, or plan to receive investigational drugs/vaccines during study participation.
• Received live attenuated vaccines or nucleic-acid vaccines within 14 days before enrollment.
• Received subunit or inactivated vaccines within 7 days before enrollment.
• Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
• Axillary temperature ≥ 37.5°C before enrollment.
• Any other factors judged by the investigators as unsuitable for participation.

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

Четверное слепое

Основная цель

Профилактика

Центры проведения

Филиппины · 1 центр

• Health Index Multispecialty Clinic (HIMC) Research and Development on Medical Sciences — Imus

Идентификаторы

NCT: NCT07593924 · PRO-PCV13-3003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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