Back to results

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

Primary Purpose

Hepatitis A

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

HAVpur Junior

Havrix 720 Junior

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Vaccination, Immunity

Eligibility Criteria

18 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Medical College and Chacha Nehru Bal Chikitsalay
Rajiv Ghandi Medical College
Christian Medical College and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAVpur

Havrix

Arm Description

Outcomes

Primary Outcome Measures

Seroprotection at Month 1

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

Secondary Outcome Measures

Seroprotection at Month 6

Proportion of subjects seroprotected (>=10 mIU/ml)

Seroprotection at Month 7

Proportion of subjects seroprotected (>=10 mIU/ml)

Geometric Mean Concentrations (GMCs)

GMCs of anti-HAV antibodies will be measured from blood samples

Geometric Mean Concentrations (GMCs)

GMCs of anti-HAV antibodies will be measured from blood samples

Geometric Mean Concentrations (GMCs)

GMCs of anti-HAV antibodies will be measured from blood samples

Full Information

NCT ID

NCT01349829

First Posted

May 5, 2011

Last Updated

October 25, 2013

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01349829

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis A

Keywords

Hepatitis A, Vaccination, Immunity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

251 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAVpur

Arm Type

Experimental

Arm Title

Havrix

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

HAVpur Junior

Intervention Description

≥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

Intervention Type

Biological

Intervention Name(s)

Havrix 720 Junior

Intervention Description

≥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

Primary Outcome Measure Information:

Title

Seroprotection at Month 1

Description

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

Time Frame

Month 1

Secondary Outcome Measure Information:

Title

Seroprotection at Month 6

Description

Proportion of subjects seroprotected (>=10 mIU/ml)

Time Frame

Month 6

Title

Seroprotection at Month 7

Description

Proportion of subjects seroprotected (>=10 mIU/ml)

Time Frame

Month 7

Title

Geometric Mean Concentrations (GMCs)

Description

GMCs of anti-HAV antibodies will be measured from blood samples

Time Frame

Month 1

Title

Geometric Mean Concentrations (GMCs)

Description

GMCs of anti-HAV antibodies will be measured from blood samples

Time Frame

Month 6

Title

Geometric Mean Concentrations (GMCs)

Description

GMCs of anti-HAV antibodies will be measured from blood samples

Time Frame

Month 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

47 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daljit Singh, MD

Organizational Affiliation

Dayanad Medical College and Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tejinder Singh, MD

Organizational Affiliation

Christian Medical College and Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hemant Jain, MD

Organizational Affiliation

Medical College and Chacha Nehru Bal Chikitsalay

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vardana Kumavat, MD

Organizational Affiliation

Rajiv Ghandi Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College and Chacha Nehru Bal Chikitsalay

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452001

Country

India

Facility Name

Rajiv Ghandi Medical College

City

Thane

State/Province

Maharashtra

ZIP/Postal Code

400 605

Country

India

Facility Name

Christian Medical College and Hospital

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141008

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs