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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_660 |
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This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ProQuadâ„¢ (V221) + Placebo Followed by ProQuadâ„¢ |
|
| 2 | Active Comparator | M-M-Râ„¢ II + VARIVAXâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live | Biological | a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline | 6 weeks Postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline |
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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 |
|---|---|---|---|
| 16094217 | Background | Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1. |
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2 clinical sites in the United States
Date of first participant visit: 24-Mar-1998
Date of last participant visit: 05-Jan-1999
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| ID | Title | Description |
|---|---|---|
| FG000 | ProQuadâ„¢ + Placebo Followed by ProQuadâ„¢ | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuadâ„¢ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. |
| FG001 | M-M-Râ„¢ II + VARIVAXâ„¢ | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProQuadâ„¢ + Placebo Followed by ProQuadâ„¢ | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuadâ„¢ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. |
| 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 | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
|
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The number of participants listed as "at risk" is the number of participants with follow-up.
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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 | ProQuadâ„¢ + Placebo Then ProQuadâ„¢ - ProQuadâ„¢ (1 Injection) | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | Merck CRISP | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Merck CRISP | Systematic Assessment |
Not provided
| 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 |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
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| Comparator: Placebo | Biological | a single 0.5 mL subcutaneous placebo injection at Day 0 |
|
| Comparator: Varivax | Biological | a single 0.5 mL subcutaneous injection of Varivax at Day 0 |
|
| Comparator: M-M-R II | Biological | a single 0.5 mL subcutaneous injection of M-M-R II at Day 0 |
|
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline |
| 6 weeks Postvaccination |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline | 6 weeks Postvaccination |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline | 6 weeks Postvaccination |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | M-M-Râ„¢ II + VARIVAXâ„¢ | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 0. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | M-M-Râ„¢ II + VARIVAXâ„¢ (1 Injection) |
|
|
| Secondary | Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
|
|
|
| Secondary | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
|
|
|
| Secondary | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
|
|
|
| Secondary | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline | Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures. | Posted | Number | Participants | 6 weeks Postvaccination |
|
|
|
| 0 |
| 321 |
| 238 |
| 321 |
| EG001 | ProQuadâ„¢ + Placebo Then ProQuadâ„¢ - ProQuadâ„¢ (2 Injections) | ProQuadâ„¢ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuadâ„¢ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. | 1 | 308 | 190 | 308 |
| EG002 | M-M-Râ„¢ II + VARIVAXâ„¢ (1 Injection) | VARIVAXâ„¢ + M-M-Râ„¢ II administered concomitantly at separate injection sites on Day 0. | 1 | 156 | 110 | 156 |
| Gastroenteritis | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Infection, rotovirus | Infections and infestations | Merck CRISP | Non-systematic Assessment |
|
| Infection, viral | Infections and infestations | Merck CRISP | Non-systematic Assessment |
|
| Infection, Viral | Infections and infestations | Merck CRISP | Non-systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
|
| Hemorrhage, Venipuncture Site | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Merck CRISP | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Gastroenteritis, Infectious | Infections and infestations | Merck CRISP | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Merck CRISP | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Merck CRISP | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Merck CRISP | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | Merck CRISP | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Congestion, Nasal | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Congestion, Respiratory | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Infection, Respiratory, Upper | Infections and infestations | Merck CRISP | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Merck CRISP | Non-systematic Assessment |
|
| Bite/Sting, Non-Venomous | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | Merck CRISP | Non-systematic Assessment |
|
| Dermatitis, Contact | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Dermatomycosis | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Miliaria Rubra | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Rash, Measles/Rubella-Like | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Rash, Varicella-Like | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Viral Exanthema | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Merck CRISP | Non-systematic Assessment |
|
| Otitis | Ear and labyrinth disorders | Merck CRISP | Non-systematic Assessment |
|
| Otitis | Ear and labyrinth disorders | Merck CRISP | Non-systematic Assessment |
|
| Erythema (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Pain/Tenderness/Soreness (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Rash (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Swelling (ProQuad Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Ecchymosis (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Non-systematic Assessment |
|
| Erythema (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Pain/Tenderness/Soreness (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Swelling (Varivax Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
| Pain/Tenderness/Soreness (M-M-R II Injection-site) | Skin and subcutaneous tissue disorders | Merck CRISP | Systematic Assessment |
|
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.
| D014777 | Virus Diseases |
| D007239 | 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 |