Hepatitis A
Conditions
Keywords
Hepatitis A, Vaccination, Immunity
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.
Interventions
BIOLOGICALHAVpur 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
BIOLOGICALHavrix 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
Crucell Holland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 47 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection at Month 1 | Month 1 | Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection at Month 6 | Month 6 | Proportion of subjects seroprotected (\>=10 mIU/ml) |
| Seroprotection at Month 7 | Month 7 | Proportion of subjects seroprotected (\>=10 mIU/ml) |
| Geometric Mean Concentrations (GMCs) | Month 1 | GMCs of anti-HAV antibodies will be measured from blood samples |
Countries
India
Participant flow
Recruitment details
Recruitment period: 25 March 2010 to 18 April 2011; outpatient study
Participants by arm
| Arm | Count |
|---|---|
| HAVpur | 126 |
| Havrix | 125 |
| Total | 251 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent withdrawal | 3 | 8 |
| Overall Study | Lost to Follow-up | 4 | 8 |
| Overall Study | Migrated/moved | 2 | 7 |
Baseline characteristics
| Characteristic | HAVpur | Havrix | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 126 Participants | 125 Participants | 251 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 27.6 months STANDARD_DEVIATION 8.45 | 27.9 months STANDARD_DEVIATION 8.23 | 27.8 months STANDARD_DEVIATION 8.33 |
| Sex: Female, Male Female | 59 Participants | 68 Participants | 127 Participants |
| Sex: Female, Male Male | 67 Participants | 57 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 126 | 24 / 125 | 4 / 118 | 6 / 108 |
| serious Total, serious adverse events | 0 / 126 | 1 / 125 | 1 / 118 | 0 / 108 |
Outcome results
Primary
Seroprotection at Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)
Time frame: Month 1
Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAVpur | Seroprotection at Month 1 | 95.9 percentage of participants |
| Havrix | Seroprotection at Month 1 | 96.6 percentage of participants |
Secondary
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 1
Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity
| Arm | Measure | Value (MEAN) |
|---|---|---|
| HAVpur | Geometric Mean Concentrations (GMCs) | 51.5 mIU/mL |
| Havrix | Geometric Mean Concentrations (GMCs) | 53.3 mIU/mL |
Secondary
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 6
Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity
| Arm | Measure | Value (MEAN) |
|---|---|---|
| HAVpur | Geometric Mean Concentrations (GMCs) | 96.0 mIU/mL |
| Havrix | Geometric Mean Concentrations (GMCs) | 113.0 mIU/mL |
Secondary
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Time frame: Month 7
Population: Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity
| Arm | Measure | Value (MEAN) |
|---|---|---|
| HAVpur | Geometric Mean Concentrations (GMCs) | 1712.4 mIU/mL |
| Havrix | Geometric Mean Concentrations (GMCs) | 2226.4 mIU/mL |
Secondary
Seroprotection at Month 6
Proportion of subjects seroprotected (\>=10 mIU/ml)
Time frame: Month 6
Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAVpur | Seroprotection at Month 6 | 98.3 percentage of participants |
| Havrix | Seroprotection at Month 6 | 99.0 percentage of participants |
Secondary
Seroprotection at Month 7
Proportion of subjects seroprotected (\>=10 mIU/ml)
Time frame: Month 7
Population: Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAVpur | Seroprotection at Month 7 | 100 percentage of participants |
| Havrix | Seroprotection at Month 7 | 100 percentage of participants |