A Prospective, Multicentre, Randomized, Double Blind, Parallel Group, Phase III Study Comparing Immunogenicity, Safety, and Tolerability of Single Dose of Hepatitis A (Live) Vaccine, Freeze-dried from Sinopharm versus BiovacTM-A (Freeze-dried Live Attenuated Hepatitis A Vaccine) from Wockhardt in Healthy Indian Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 4
- 主要终点
- Proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL)
研究概览
简要总结
This is a prospective, multicentre, randomized, double blind, parallel group, phase III study in which immunogenicity, safety, and tolerability of single dose of Hepatitis a (live) vaccine, freeze-dried from sinopharm versus is compared with BiovacTM a (freeze-dried live attenuated hepatitis a vaccine) from Wockhardt. The study involves approximately 176 healthy Indian children, who had not received hepatitis a vaccine and had anti-HAV ab levels of < 20 mIU/ml prior to enrolment into the study, after 8 weeks of immunization.
The study has to be conducted approximately at 5 sites in India with a primary objective of comparing the immune response of healthy Indian children treated with test drug/ vaccine versus reference drug/vaccine. The secondary objective of the study is to compare the safety and tolerability profile of test and reference drug/vaccine.
The study consists of 3 visits:
· Visit 1 (Day -5)(Screening Visit)
· Visit 2 (Day 0 + 2 days) (Baseline Visit)
· Visit 3 (Week 8 +7 days) (End of Study [EOS] Visit)
At week 8, proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL) will be assessed which is the primary endpoint of the study. Adverse events (AEs) and serious AEs (SAEs), Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks, Change in brief clinical examination from baseline to 8 weeks, Vital signs, Immediate and delayed reaction post vaccination are to be assessed as secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children of either sex between the age range of 1-12 years
- •Subjects with negative anti-HAV antibodies (< 20mIU/ml)
- •Subjects’ parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children.
排除标准
- •Subject with history of hypersensitivity to the vaccine or any of the ingredients of the vaccine, including subsidiary materials and kanamycin sulfate
- •Subject with previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection
- •Subjects who have earlier received even a single dose of Hepatitis A vaccine
- •Subjects who were administered any live attenuated vaccine within 30 days.
- •Subjects who were administered subunit or inactivated vaccines within 14 days
- •Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease
- •Subjects suffering from acute febrile illnesses 8.Subjects with a present or past history of allergic reactions.
- •Subjects with clinically significant abnormal hematological and/or biochemical investigations.
- •Subjects who have participated in an investigational study within the past 2 weeks
- •Subjects currently receiving immunosuppressant drugs 12.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system
- •Subjects with any other illnesses which may impact the immune response or seroconversion as per investigator’s discretion
- •Subjects unwilling to comply with the study procedures
- •Subjects with immunodeficiency, HIV, and/or who are immunocompromised
- •Subjects with a history of administration of a single dose of Hepatitis A vaccine and/or any immunoglobulin at least 3 months prior to enrollment.
结局指标
主要结局
Proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL)
时间窗: At 8 week from the day of immunization.
次要结局
- • Adverse events (AEs) and serious AEs (SAEs)(• Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks)