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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_023 |
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Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Arm 1: vaccine |
|
| 2 | Active Comparator | Arm 2: Active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAQTA® | Biological | 0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With 1 or More Serious Vaccine-Related Adverse Experiences | Days 1 to 14 after any vaccination | |
| Participants With 1 or More Injection-Site Adverse Experiences | Days 1 to 14 after any vaccination | |
| Participants With Measles-Like Rash After First Vaccination | Days 1 to 28 After First Vaccination | |
| Participants With Measles-Like Rash After Second Vaccination | Days 1 to 28 After Second Vaccination | |
| Participants With Mumps-Like Symptoms After First Vaccination | Days 1 to 28 After First Vaccination | |
| Participants With Mumps-Like Symptoms After Second Vaccination | Days 1 to 28 After Second Vaccination | |
| Participants With Rubella-Like Rash After First Vaccination | Days 1 to 28 After First Vaccination | |
| Participants With Rubella-Like Rash After Second Vaccination | Days 1 to 28 After Second Vaccination | |
| Participants With Varicella/Zoster-Like Rash After First Vaccination | Days 1 to 28 After First Vaccination | |
| Participants With Varicella/Zoster-Like Rash After Second Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With 1 or More Systemic Adverse Experiences | Days 1 to 14 After Any Vaccination |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30431383 | Background | Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15. |
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18 investigators in the United States; Date of first subject visit: 26-Mar-2007.
Date of last subject visit: 14-Nov-2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: VAQTA™ | Hepatitis A vaccine, inactivated |
| FG001 | Arm 2: VAQTA™ +ProQuad™ | Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: VAQTA™ | Hepatitis A vaccine, inactivated |
| BG001 | Arm 2: VAQTA™ +ProQuad™ | Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Participants With 1 or More Serious Vaccine-Related Adverse Experiences | Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled. | Posted | Number | participants | Days 1 to 14 after any vaccination |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| C050102 | measles, mumps, rubella, varicella vaccine |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| ProQuad | Biological | 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment. |
|
| Days 1 to 28 After Second Vaccination |
| Participants With Elevated Temperature (>=102.2F/39.0C) | Days 1 to 5 After Any Vaccination |
| Withdrawal by Subject |
|
| Subject Moved |
|
| Other |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Participants With 1 or More Systemic Adverse Experiences | Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled. | Posted | Number | participants | Days 1 to 14 After Any Vaccination |
|
|
|
| Primary | Participants With 1 or More Injection-Site Adverse Experiences | Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled. | Posted | Number | participants | Days 1 to 14 after any vaccination |
|
|
|
| Primary | Participants With Measles-Like Rash After First Vaccination | Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After First Vaccination |
|
|
|
| Primary | Participants With Measles-Like Rash After Second Vaccination | Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After Second Vaccination |
|
|
|
| Primary | Participants With Mumps-Like Symptoms After First Vaccination | Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms. | Posted | Number | participants | Days 1 to 28 After First Vaccination |
|
|
|
| Primary | Participants With Mumps-Like Symptoms After Second Vaccination | Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms. | Posted | Number | participants | Days 1 to 28 After Second Vaccination |
|
|
|
| Primary | Participants With Rubella-Like Rash After First Vaccination | Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After First Vaccination |
|
|
|
| Primary | Participants With Rubella-Like Rash After Second Vaccination | Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After Second Vaccination |
|
|
|
| Primary | Participants With Varicella/Zoster-Like Rash After First Vaccination | Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After First Vaccination |
|
|
|
| Primary | Participants With Varicella/Zoster-Like Rash After Second Vaccination | Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes. | Posted | Number | participants | Days 1 to 28 After Second Vaccination |
|
|
|
| Primary | Participants With Elevated Temperature (>=102.2F/39.0C) | Includes all subjects who provided body temperature follow-up data after any dose of vaccine. | Posted | Number | participants | Days 1 to 5 After Any Vaccination |
|
|
|
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.
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D045424 |
| Complex Mixtures |