Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAVpur | Experimental |
| |
| Havrix | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection at Month 1 | Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml) | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection at Month 6 | Proportion of subjects seroprotected (>=10 mIU/ml) | Month 6 |
| Seroprotection at Month 7 | Proportion of subjects seroprotected (>=10 mIU/ml) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College and Chacha Nehru Bal Chikitsalay | Indore | Madhya Pradesh | 452001 | India | ||
| Rajiv Ghandi Medical College |
Not provided
Recruitment period: 25 March 2010 to 18 April 2011; outpatient study
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HAVpur | |
| FG001 | Havrix |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HAVpur | |
| BG001 | Havrix | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroprotection at Month 1 | Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml) | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | Month 1 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HAVpur - First Vaccination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | info@crucell.com |
Not provided
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Havrix 720 Junior | Biological | ≥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 |
|
| Month 7 |
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 1 |
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 6 |
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 7 |
| Thane |
| Maharashtra |
| 400 605 |
| India |
| Christian Medical College and Hospital | Ludhiana | Punjab | 141008 | India |
| Migrated/moved |
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Seroprotection at Month 6 | Proportion of subjects seroprotected (>=10 mIU/ml) | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
|
|
|
| Secondary | Seroprotection at Month 7 | Proportion of subjects seroprotected (>=10 mIU/ml) | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | Month 7 |
|
|
|
| Secondary | Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | 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 | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 1 |
|
|
|
| Secondary | Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | 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 | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 6 |
|
|
|
| Secondary | Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | 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 | Posted | Mean | 95% Confidence Interval | mIU/mL | Month 7 |
|
|
|
| 0 |
| 126 |
| 24 |
| 126 |
| EG001 | Havrix - First Vaccination | 1 | 125 | 24 | 125 |
| EG002 | HAVPur - Second Vaccination | 1 | 118 | 4 | 118 |
| EG003 | Havrix - Second Vaccination | 0 | 108 | 6 | 108 |
| Typhoid fever | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Injection site pain (solicited) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyrexia (solicited) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site swelling (solicited) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Injection site erythema (solicited) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia (unsolicited) | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Helminthic infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |