This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
251
≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months
≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months
Medical College and Chacha Nehru Bal Chikitsalay
Indore, Madhya Pradesh, India
Rajiv Ghandi Medical College
Thane, Maharashtra, India
Christian Medical College and Hospital
Ludhiana, Punjab, India
Seroprotection at Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)
Time frame: Month 1
Seroprotection at Month 6
Proportion of subjects seroprotected (\>=10 mIU/ml)
Time frame: Month 6
Seroprotection at Month 7
Proportion of subjects seroprotected (\>=10 mIU/ml)
Time frame: Month 7
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 1
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 6
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.