MedTrace Logo

A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

NCT01349829 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2013-12-17

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

HAVpur Junior

≥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

BIOLOGICAL

Havrix 720 Junior

≥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

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Daljit Singh, MD · Dayanad Medical College and Hospital

  • Tejinder Singh, MD · Christian Medical College and Hospital

  • Hemant Jain, MD · Medical College and Chacha Nehru Bal Chikitsalay

  • Vardana Kumavat, MD · Rajiv Ghandi Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349829 on ClinicalTrials.gov