NCT01349829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 17, 2013

Completed
Last Updated

December 17, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

May 5, 2011

Results QC Date

October 25, 2013

Last Update Submit

October 25, 2013

Conditions

Hepatitis A

Keywords

Hepatitis AVaccinationImmunity

Outcome Measures

Primary Outcomes (1)

  • Seroprotection at Month 1

    Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)

    Month 1

Secondary Outcomes (5)

  • Seroprotection at Month 6

    Month 6

  • Seroprotection at Month 7

    Month 7

  • Geometric Mean Concentrations (GMCs)

    Month 1

  • Geometric Mean Concentrations (GMCs)

    Month 6

  • Geometric Mean Concentrations (GMCs)

    Month 7

Study Arms (2)

HAVpur

EXPERIMENTAL
Biological: HAVpur Junior

Havrix

ACTIVE COMPARATOR
Biological: Havrix 720 Junior

Interventions

HAVpur JuniorBIOLOGICAL

≥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

HAVpur
Havrix 720 JuniorBIOLOGICAL

≥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

Havrix

Eligibility Criteria

Age18 Months - 47 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A male or female between (and including) 18 months to 47 months of age.
  • Written informed consent obtained from the parent/legal guardian of the subject.
  • Free of obvious health problems as established by medical history and/or clinical examination before entering the study

You may not qualify if:

  • Seropositive for anti-HAV antibodies (\>=10 mIU/ml).
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, \>=0.5 mg/kg/day.
  • Inhaled and local steroids are allowed.)
  • Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
  • Previous vaccination against hepatitis A.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical College and Chacha Nehru Bal Chikitsalay

Indore, Madhya Pradesh, 452001, India

Location

Rajiv Ghandi Medical College

Thane, Maharashtra, 400 605, India

Location

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

MeSH Terms

Conditions

Hepatitis A

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Medical Affairs Director
Organization
Crucell Switzerland AG
info@crucell.com
+41(0)319806111

Study Officials

  • Daljit Singh, MD

    Dayanad Medical College and Hospital

    PRINCIPAL INVESTIGATOR

  • Tejinder Singh, MD

    Christian Medical College and Hospital

    PRINCIPAL INVESTIGATOR

  • Hemant Jain, MD

    Medical College and Chacha Nehru Bal Chikitsalay

    PRINCIPAL INVESTIGATOR

  • Vardana Kumavat, MD

    Rajiv Ghandi Medical College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 9, 2011

Study Start

March 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

December 17, 2013

Results First Posted

December 17, 2013

Record last verified: 2013-08

Locations

IN(3)