A Blind Randomized Clinical Trial, With Active Controls, to Evaluate the Immunogenicity and Safety of the Quadrivalent Influenza Vaccine (Split Virion, Inactivated) From Instituto Butantan, in Infants and Children Aged 6 to 35 Months.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,373
- 试验地点
- 10
- 主要终点
- Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
研究概览
简要总结
This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.
详细描述
The study will be carried out in multiple sites in Brazil, using a community-based recruitment strategy.
The study interventions are the Butantan Quadrivalent Influenza Vaccine (split virion, inactivated) in two dose scheme (QIV-IB/0.25ml and QIV-IB/0.50ml) and the active controls Butantan Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria or Yamagata lineage (TIVV-IB and TIVY-IB), in a ratio 1:1:1:1.
The study population is healthy infants and children aged 6 to 35 months and all participants will be followed up 6 months after the last vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant and child of either sex aged between 6 and 35 months on the day of the first study vaccination.
- •Born at term (≥ 37 weeks of gestational age) and birth weight ≥ 2.5 kg.
- •Parents/legal guardians of the infant or child able and willing to attend all scheduled visits and comply with all study procedures, including blood draws.
- •Parents/legal guardians of the infant or child have provided informed consent.
排除标准
- •Having received any influenza vaccine from the current season and/or 6 months before the first study vaccination.
- •History of allergy to egg, chicken proteins, or other components of the influenza vaccine.
- •History of serious adverse reaction to any influenza vaccine.
- •Have any clinically significant condition or situation that, in the Investigator's opinion, would interfere with study evaluations or participation.
- •History of Guillain-Barré or other demyelinating diseases.
- •History of neurological disease and/or clinically significant developmental delay (at the discretion of the Investigator), or seizure (except for an isolated febrile seizure episode).
- •Having received immune globulin, blood, or any blood product 3 months before the planned date of the first study vaccination or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive condition, congenital or acquired immunodeficiency (including human immunodeficiency virus - HIV) based on medical history and physical examination.
- •Immediate personal or family history of congenital immunodeficiency.
- •Having received or are using radiation therapy, chemotherapy, immunosuppressive drugs, or other immunomodulatory drugs within three months before the planned date of the first study vaccination or planned use during the study.
- •Be a solid organ or bone marrow/stem cell transplant recipient.
- •Thrombocytopenia, bleeding disorder, use of anticoagulants, or any condition that contraindicates intramuscular injection.
- •Significant chronic disease (cancer, autoimmune disease, diabetes mellitus, acute or progressive liver disease, acute or progressive kidney disease, severe heart or lung disease) or which in the Investigator's opinion poses a risk to the health of the infant or child participating in the study or which may interfere with the conduct or conclusion of the study.
- •History of seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Major surgery or surgery using general anesthesia planned to occur during the period between the first vaccination and 28 days after full vaccination in the study.
- •Any condition that, in the opinion of the Investigator, may interfere with the conduct or completion of the study (such as travelling or planned moving of residence, among others).
- •Participation in another clinical trial involving another experimental or unregistered product 1 year before the planned date of the study's first vaccination, or plans to entering a clinical trial during the study.
- •Infant and institutionalized child.
- •Be related to the Investigator, research site staff member, or employee directly involved in the study.
- •Postponement Criteria:
- •Have received any vaccine (including routine childhood vaccines) within 28 days of the first study vaccination (delay until the 28-day deadline from the date of the last vaccination).
- •Moderate or severe (as judged by the Investigator) acute illness/infection or febrile illness (temperature ≥ 37.8°C) 48 hours before the planned date of the first study vaccination.
- •Acute respiratory illness within 14 days preceding the planned date of the first study vaccination.
研究组 & 干预措施
QIV-IB/dose 0.25ml
Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml
干预措施: Quadrivalent Influenza Vaccine (split virion, inactivated) (Biological)
QIV-IB/dose 0.50ml
Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.50ml
干预措施: Quadrivalent Influenza Vaccine (split virion, inactivated) (Biological)
TIVV-IB
Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Victoria lineage
干预措施: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage (Biological)
TIVY-IB
Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Yamagata lineage
干预措施: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage (Biological)
结局指标
主要结局
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
时间窗: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.
时间窗: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
时间窗: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.
时间窗: 28 days after last vaccination
Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.
次要结局
- Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by QIV-IB/0.25ml, for each strain, in infants and children from 6 to 35 months of age.(28 days after last vaccination)
- Pre- and post-vaccination Geometric Mean Titers (GMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.(At Days 0 and 28/56)
- Ratio of Pre- and post-vaccination Geometric Mean Titers (rGMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.(At Days 0 and 28/56)
- Solicited local Site or Systemic Reactions After each Injection(Day 0 up to Day 7 post-injection)
- Percentage of Participants achieving seroprotection (Seroprotection Rate - SPR) to Influenza Vaccine Antigens.(At Days 0 and 28/56)
- Serious Adverse Events (SAE) and adverse events of special interest (AESI)(Entire study participant's follow-up period (6 months after the last vaccination))
- Percentage of Participants With Seroconversion (Seroconversion Rate - SCR) to Influenza Vaccine Antigens.(At Days 0 and 28/56)
- Related Unsolicited Adverse Events(28 days after last vaccination)