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| ID | Type | Description | Link |
|---|---|---|---|
| MRV01C | Other Identifier | Sanofi Pasteur MSD Protocol Number | |
| 2007-002438-12 | EudraCT Number |
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Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.
Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProQuad® | Experimental | Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProQuad® | Biological | ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 | The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 | The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2. | Up to Day 46 (for 4 days following ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 | The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 | Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1 | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1. | From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1) |
| Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne FIQUET, MD | MCM Vaccines B.V. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22772170 | Derived | Ruger G, Gabutti G, Rumke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Hogh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b. |
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Healthy pediatric participants were enrolled at 84 study centers in 7 European countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | ProQuad® | Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProQuad® | Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle. |
| 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 | Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 | The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
ProQuad® Dose 1: Up to Day 28 ProQuad® Dose 2: Up to Day 84 (up to 42 days after Dose 2)
Participants who were vaccinated and have safety follow-up data are included. Data are presented separately for each post-dose monitoring period.
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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 | ProQuad® Arm: Dose 2 | Healthy infants (12 to 22 months of age) received ProQuad® Dose 2 on Day 28 to Day 42. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyanosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 10.0 | 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 |
| 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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Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.
| Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 | Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 | Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 | The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined. | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 | Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event. | Up to Day 84 (up to 42 days after ProQuad® Dose 2) |
| Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 | Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event. | Up to Day 84 (up to 42 days after ProQuad® Dose 2) |
Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection. |
| Up to Day 28 (28 days after ProQuad® Dose 1) |
| Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1 | The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined. | Up to Day 28 (28 days after ProQuad® Dose 1) |
| Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1 | Systemic AEs were monitored for up to 28 days after the first ProQuad® injection. | Up to Day 28 (28 days after ProQuad® Dose 1) |
| Adverse Event |
|
| Physician Decision |
|
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 | The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 46 (for 4 days following ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 | The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 | Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 | Systemic AEs were monitored for up to 28 days after the second ProQuad® injection. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 | Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 | Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 | The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined. | All participants who received the second ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 70 (up to 28 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 | Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 84 (up to 42 days after ProQuad® Dose 2) |
|
|
|
| Primary | Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 | Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 84 (up to 42 days after ProQuad® Dose 2) |
|
|
|
| Secondary | Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1 | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1) |
|
|
|
| Secondary | Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1 | Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 28 (28 days after ProQuad® Dose 1) |
|
|
|
| Secondary | Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1 | The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | Percentage of Participants | Up to Day 28 (28 days after ProQuad® Dose 1) |
|
|
|
| Secondary | Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1 | Systemic AEs were monitored for up to 28 days after the first ProQuad® injection. | All participants who received the first ProQuad® dose and had safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 28 (28 days after ProQuad® Dose 1) |
|
|
|
| 22 |
| 3,342 |
| 1,507 |
| 3,342 |
| EG001 | ProQuad® Arm: Dose 1 | Healthy infants (12 to 22 months of age) received ProQuad® Dose 1 on Day 1. | 40 | 3,376 | 2,057 | 3,376 |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diabetes mellitus insulin-dependent | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep terror | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v. 10.0 | Systematic Assessment |
|
| Acute tonsilitis | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Gastroenteritis Norwalk virus | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Pseudocroup | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Tonsilitis | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA v. 10.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v. 10.0 | Systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA v. 10.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA v. 10.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v. 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v. 10.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v. 10.0 | Systematic Assessment |
|
| Rhinits | Infections and infestations | MedDRA v. 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v. 10.0 | Systematic Assessment |
|
| Rash mobilliform | Skin and subcutaneous tissue disorders | MedDRA v. 10.0 | Systematic Assessment |
|
Sanofi Pasteur MSD shall have sixty days to review these documents and may refuse to give its consent in part or whole for confidential reasons (including but not limited to intellectual property rights, whether patentable or not).
| 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 |
|
| Title | Measurements |
|---|---|
|
| Zoster-like rash |
|
|