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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_510 |
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This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.
This treatment has been approved for sale to the public.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VARIVAX 2007 process + M-M-R II | Experimental |
| |
| VARIVAX 1999 process + M-M-R II | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Virus Vaccine Live (2007 Process) (Oka/Merck) | Biological | VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only. | 6 weeks following first 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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| ID | Title | Description |
|---|---|---|
| FG000 | VARIVAX 2007 Process + M-M-R II | VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart |
| FG001 | VARIVAX 1999 Process + M-M-R II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose 1 Vaccination |
|
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| Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck) | Biological | VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart |
|
| Measles, Mumps, and Rubella Virus Vaccine Live (MMR) | Biological | M-M-R II in two 0.5 mL doses by injection ~6 weeks apart |
|
VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart |
| COMPLETED |
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| NOT COMPLETED |
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| Dose 2 Vaccination |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VARIVAX 2007 Process + M-M-R II | VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart |
| BG001 | VARIVAX 1999 Process + M-M-R II | VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only. | Per protocol population | Posted | Number | Percent of participants | 6 weeks following first vaccination |
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Number of participants at risk for the 2007 process is the number who received the first dose.
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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 | VARIVAX 2007 Process + M-M-R II | VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart | 1 | 296 | 189 | 296 | ||
| EG001 | VARIVAX 1999 Process + M-M-R II | VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart | 1 | 299 | 156 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Croup infectious | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
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| Male |
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