Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine

Официальное название

A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) 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 pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.

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 Chinese pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). 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 Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.

Вмешательства

• Биопрепарат Sinovac PCV13
  One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.
• Биопрепарат Prevnar®
  One dose of Prevnar® (0.5 mL) is administered intramuscularly.

Первичные конечные точки

• Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) [Срок оценки: 30 days after primary vaccination]
• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) [Срок оценки: 30 days after primary vaccination]

Вторичные конечные точки (12)

• Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) [Срок оценки: 30 days after booster vaccination]
• Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) [Срок оценки: 30 days after booster vaccination]
• Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8 [Срок оценки: 30 days after primary vaccination]
• Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) [Срок оценки: 30 days after primary vaccination]
• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL [Срок оценки: 30 days after primary vaccination]
• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) [Срок оценки: 30 days after primary vaccination]
• Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI) [Срок оценки: 30 days after primary vaccination]
• Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL [Срок оценки: 30 days after booster vaccination]
• Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) [Срок оценки: 30 days after booster vaccination]
• Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate) [Срок оценки: 30 days after booster vaccination]
• Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) [Срок оценки: 30 days after booster vaccination]
• Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI) [Срок оценки: 30 days after booster vaccination]

Критерии участия

Критерии включения

• Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);
• Participants' guardians provide legal identity document and participants' vaccination record;
• Participants' guardians understand and voluntarily sign the informed consent form;
• Participants' guardians can follow all study procedures and stay in contact during the study.

Критерии исключения

• Received any pneumococcal vaccine prior to enrollment;
• History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
• History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;
• History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
• Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);
• Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.
• Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
• History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
• Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years.
• Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
• Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study;
• Received live attenuated vaccine within 14 days prior to enrollment;
• Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
• Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;
• Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;
• In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.

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

Китай · 1 центр

• Henan Provincial Center for Disease Control and Prevention — Чжэнчжоу

Идентификаторы

NCT: NCT06617715 · PRO-PCV-3001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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