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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_531 |
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This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | VAQTA™ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A Vaccine, Purified Inactivated (VAQTA™) | Biological | Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines. | Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL. | Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination | All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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114 subjects were enrolled for vaccination screening. Subject eligibility was reviewed according to the inclusion/exclusion criteria, and blood samples were collected for HAV (hepatitis A virus) antibody and ALT (alanine aminotransferase) testing. Finally 80 HAV-susceptible subjects with normal ALT were administered vaccines at the Day 1
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| ID | Title | Description |
|---|---|---|
| FG000 | VAQTA™ | Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VAQTA™ | Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines. | Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL. | Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria. | Posted | Number | Percentage of Participants | Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAQTA™ | Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site redness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Body Temperature | Mean | Standard Deviation | Degrees Celsius |
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| Pulse | Mean | Standard Deviation | Beats per minute (BPM) |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | VAQTA™ | Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively. |
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| Secondary | Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination | All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection. | Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data | Posted | Number | participants | For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination |
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| 0 |
| 80 |
| 56 |
| 80 |
| Injection site pain | General disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Injection site pruritus | General disorders | Systematic Assessment |
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| Hypersomnia | Nervous system disorders | Systematic Assessment |
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| Fidgety | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Inappetency | Gastrointestinal disorders | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchopenumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Allergic reaction | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D045424 |
| Complex Mixtures |
| Title | Measurements |
|---|---|
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