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.

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009760

Enrollment

176

Registered

2017-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Hepatitis A (Live) Vaccine: Single Dose of Hepatitis A (Live) Vaccine, Freeze-dried from Sinopharm Control Intervention1: Biovac-A: (Freeze-dried Live Attenuated Hepatitis A Vaccine) fr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy children of either sex between the age range of 1-12 years 2. Subjects with negative anti-HAV antibodies ( 3. Subjectsâ?? parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
â?¢ Adverse events (AEs) and serious AEs (SAEs) â?¢ Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks â?¢ Change in brief clinical examination from baseline to 8 weeks â?¢ Vital signs â?¢ Immediate and delayed reaction post vaccination Timepoint: At 8 week from the day of immunization.	—

Countries

India

Contacts

Public ContactDr Shariq Anwar

JSS Medical Research India Private Limited

sonika.newar@jssresearch.com91800799887

Outcome results