Comparison of immunogenicity, safety and tolerability of Single Dose of Hepatitis A (Live) Vaccine obtained by Freeze-dried process from Sinopharm against BiovacTM-A (Freeze-dried Live Attenuated Vaccine from Wockhardt)in Healthy Indian Children.
- Registration Number
- CTRI/2017/09/009760
- Lead Sponsor
- Sinopharm India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy children of either sex between the age range of 1-12 years
2. Subjects with negative anti-HAV antibodies ( < 20mIU/ml)
3. Subjectsâ?? parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children
1. Subject with history of hypersensitivity to the vaccine or any of the ingredients of the vaccine, including subsidiary materials and kanamycin sulfate
2. Subject with previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection
3. Subjects who have earlier received even a single dose of Hepatitis A vaccine
4. Subjects who were administered any live attenuated vaccine within 30 days.
5. Subjects who were administered subunit or inactivated vaccines within 14 days
6. Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease
7. Subjects suffering from acute febrile illnesses
8.Subjects with a present or past history of allergic reactions.
9. Subjects with clinically significant abnormal hematological and/or biochemical investigations.
10. Subjects who have participated in an investigational study within the past 2 weeks
11. Subjects currently receiving immunosuppressant drugs
12.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system
13. Subjects with any other illnesses which may impact the immune response or seroconversion as per investigatorâ??s discretion
14. Subjects unwilling to comply with the study procedures
15. Subjects with immunodeficiency, HIV, and/or who are immunocompromised
16. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level â?¥ 20 mIU/mL)Timepoint: At 8 week from the day of immunization. <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢ Adverse events (AEs) and serious AEs (SAEs) <br/ ><br>â?¢ Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks <br/ ><br>â?¢ Change in brief clinical examination from baseline to 8 weeks <br/ ><br>â?¢ Vital signs <br/ ><br>â?¢ Immediate and delayed reaction post vaccination <br/ ><br>Timepoint: At 8 week from the day of immunization.