A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,992
- 试验地点
- 14
- 主要终点
- Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
研究概览
简要总结
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants aged ≥ 6 months to < 18 years at the time of vaccination;
- •Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC;
- •Good health, as determined by medical history, and a targeted physical examination;
- •For participants aged < 9 years, born after a normal gestation period (between 36 and 42 weeks);
- •Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.
排除标准
- •Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
- •Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry;
- •Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
- •Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months;
- •Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination;
- •Pregnant or lactating females;
- •Clinically significant medical or psychiatric conditions, as follows:
- •For acute conditions (active or recent), the condition required hospitalisation within the last month; or
- •For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
- •i. requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or
- •The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
- •Confirmed or suspected immune deficiency (congenital or acquired, including cancer and human immunodeficiency virus infection);
- •History of seizures, with the exception of a past history of a single seizure event at any age more than two years previously;
- •Known history of Guillain-Barré Syndrome;
- •Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6 months prior to administration of the Study Vaccine;
- •Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
- •Chronic or long term corticosteroids: i. Age less than 9 years: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent daily; ii. Age 9 years and above: ≥ 15 mg/day of oral prednisolone or equivalent daily;
- •Sporadic corticosteroids: i. Age less than 9 years: ≥ 1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months preceding vaccination; ii. Age 9 years and above: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination; Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study;
- •Current treatment with warfarin or other anticoagulants;
- •Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or entry into such a study during the on study period;
- •Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
- •If, in the Investigator's opinion, the participant should not take part in the clinical study.
研究组 & 干预措施
Cohort C
Participants aged 9 years to less than 18 years
干预措施: CSL Limited Influenza Virus Vaccine (Biological)
Cohort A
Participants aged 6 months to less than 3 years
干预措施: CSL Limited Influenza Virus Vaccine (Biological)
Cohort B
Participants aged 3 years to less than 9 years
干预措施: CSL Limited Influenza Virus Vaccine (Biological)
结局指标
主要结局
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
时间窗: 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
次要结局
- Frequency and Intensity of Unsolicited Adverse Events (UAEs)(30 days after each study vaccination)
- Frequency of Serious Adverse Events(180 days after the last study vaccination)
- Frequency of New Onsets of Chronic Illness(180 days after the last study vaccination)