HAVpur Junior
Biological≥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
NCT Number: NCT01349829
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.
Looking for future studies?
Notify Me18 month–47 month
All sexes
Interventional
Phase 4
Medical College and Chacha Nehru Bal Chikitsalay, Indore, Madhya Pradesh, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
≥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
Time frame: Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Time frame: Month 6
Proportion of subjects seroprotected (>=10 mIU/ml)
Time frame: Month 7
Proportion of subjects seroprotected (>=10 mIU/ml)
Time frame: Month 1
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 6
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 7
GMCs of anti-HAV antibodies will be measured from blood samples
Crucell Holland BV
Industry
A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06576024
Blood-Borne Infections, Communicable Diseases
Liuzhou, Guangxi, China
View Trial DetailsNCT06298708
Digestive System Diseases, Enterovirus Infections
Chiang Mai, Thailand
View Trial DetailsNCT03312699
Bacterial Infections, Bacterial Infections and Mycoses
Stanford, California, United States
View Trial DetailsNCT00139113
Digestive System Diseases, Enterovirus Infections
Anchorage, Alaska, United States
View Trial Details