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| ID | Type | Description | Link |
|---|---|---|---|
| MRV02C | Other Identifier | Sanofi Pasteur Merck Sharp & Dohme (SPMSD) Protocol Number |
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The primary study objectives are:
The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 11 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
If the first primary hypothesis was demonstrated, the second primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.
The secondary study objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ProQuad® at 9 and 12 months | Experimental | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age. |
|
| Arm 2: ProQuad® at 11 and 14 months | Experimental | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age. |
|
| Arm 3: ProQuad at 12 and 15 months | Active Comparator | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProQuad® manufactured with recombinant Human Albumin (rHA) | Biological | A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 | Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | Day 132 (6 weeks after ProQuad® Dose 2) |
| Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 | Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | Day 132 (6 weeks after ProQuad® Dose 2) |
| Percentage of Participants With Solicited Injection-site Adverse Reactions | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1. | Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1 | Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | SPMSD | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22406278 | Derived | Vesikari T, Becker T, Gajdos V, Fiquet A, Thomas S, Richard P, Baudin M. Immunogenicity and safety of a two-dose regimen of a combined measles, mumps, rubella and varicella live vaccine (ProQuad((R))) in infants from 9 months of age. Vaccine. 2012 Apr 26;30(20):3082-9. doi: 10.1016/j.vaccine.2012.02.062. Epub 2012 Mar 7. |
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Pediatric participants from 9 to 12 months of age at the start of the study were recruited at 48 study centers in Finland, France, and Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: ProQuad® at 9 and 12 Months | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age. |
| FG001 | Arm 2: ProQuad® at 11 and 14 Months | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age. |
| FG002 | Arm 3: ProQuad® at 12 and 15 Months | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: ProQuad® at 9 and 12 Months | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age. |
| BG001 | Arm 2: ProQuad® at 11 and 14 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at inclusion in study. |
| 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 in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 | Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | All baseline seronegative participants with immunogenicity data are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 132 (6 weeks after ProQuad® Dose 2) |
|
Up to 146 days (up to 56 days after Dose 2)
An adverse event is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Participants who received at least one dose of ProQuad® and have follow-up data available are included.
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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 | Arm 1: ProQuad® at 9 and 12 Months | Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal 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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|
| Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions | The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined. | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
| Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1 | The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined. | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
| Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C | The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined. | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
| Day 42 (6 weeks after ProQuad® Dose 1) |
| GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2 | Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL. | Day 132 (6 weeks after ProQuad® Dose 2) |
| Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL | The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined. | Day 132 (6 weeks after ProQuad® Dose 2) |
| Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1 | The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | Day 42 (6 weeks after ProQuad® Dose 1) |
| Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1 | The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash. | Up to Day 28 (up to 4 weeks after ProQuad® Dose 1) |
| Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2 | The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash. | Day 132 (6 weeks after ProQuad® Dose 2) |
| Physician Decision |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.
| BG002 | Arm 3: ProQuad® at 12 and 15 Months | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Arm 2: ProQuad® at 11 and 14 Months | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age. |
| OG001 | Arm 3: ProQuad® at 12 and 15 Months | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age. |
|
|
|
| Primary | Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2 | Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | All baseline seronegative participants with immunogenicity data are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 132 (6 weeks after ProQuad® Dose 2) |
|
|
|
|
| Primary | Percentage of Participants With Solicited Injection-site Adverse Reactions | The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1. | All participants who received ProQuad® Dose 1 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 4 (up to 4 days after ProQuad® Dose 1) |
|
|
|
| Primary | Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions | The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined. | All participants who received ProQuad® Dose 1 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
|
|
|
| Primary | Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1 | The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined. | All participants who received ProQuad® Dose 1 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
|
|
|
| Primary | Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C | The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined. | All participants who received ProQuad® Dose 1 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 28 (up to 28 days after ProQuad® Dose 1) |
|
|
|
| Secondary | Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1 | Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL. | All participants with seronegative baselines who received ProQuad® Dose 1 and have immunogenicity data available are included. | Posted | Geometric Mean | 95% Confidence Interval | GMT | Day 42 (6 weeks after ProQuad® Dose 1) |
|
|
|
| Secondary | GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2 | Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL. | All participants with seronegative baselines who received ProQuad® Dose 2 and have immunogenicity data available are included. | Posted | Geometric Mean | 95% Confidence Interval | GMT | Day 132 (6 weeks after ProQuad® Dose 2) |
|
|
|
| Secondary | Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL | The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined. | All participants who received ProQuad® and have serology results are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 132 (6 weeks after ProQuad® Dose 2) |
|
|
|
| Secondary | Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1 | The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL. | All baseline seronegative participants with immunogenicity data are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 (6 weeks after ProQuad® Dose 1) |
|
|
|
| Secondary | Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1 | The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash. | All participants who received ProQuad® Dose 1 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 28 (up to 4 weeks after ProQuad® Dose 1) |
|
|
|
| Secondary | Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2 | The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash. | All participants who received ProQuad® Dose 2 and have safety follow-up data available are included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 132 (6 weeks after ProQuad® Dose 2) |
|
|
|
| 21 |
| 541 |
| 468 |
| 541 |
| EG001 | Arm 2: ProQuad® at 11 and 14 Months | Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age. | 15 | 540 | 430 | 540 |
| EG002 | Arm 3: ProQuad® at 12 and 15 Months | Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age. | 17 | 539 | 401 | 539 |
| Bronchiolitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis Norwalk virus | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis adenovirus | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 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 |
| Mumps |
|
|
| Rubella |
|
|
| Varicella |
|
|
Mumps difference
| Mumps Response Rate (Arm 1 - Arm 3) |
| -0.35 |
| 2-Sided |
| 95 |
| -1.71 |
| 1.01 |
| Non-Inferiority or Equivalence |
Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages. |
| Rubella difference | Rubella Response Rate (Arm 1 - Arm 3) | -0.15 | 2-Sided | 95 | -1.34 | 1.09 | Non-Inferiority or Equivalence | Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages. |
| Varicella difference | Varicella Response Rate (Arm 1 - Arm 3) | 0.00 | 2-Sided | 95 | -1.83 | 1.10 | Non-Inferiority or Equivalence | Non-inferiority was declared when the lower bound of the 95% CI was > -10. Values are shown as percentages. |
|
| Injection-site swelling |
|
| Mumps (ELISA Ab units/mL) |
|
|
| Rubella (IU/mL) |
|
|
| Varicella (gpELISA units/mL) |
|
|
| Mumps (ELISA Ab units/mL) |
|
|
| Rubella (IU/mL) |
|
|
| Varicella {gpELISA units/mL) |
|
|
| ProQuad® Dose 2 |
|
|
| Mumps |
|
|
| Rubella |
|
|
| Varicella |
|
|
|
| Varicella-like rash |
|
| Zoster-like rash |
|
| Mumps-like illness |
|
|
| Varicella-like rash |
|
| Zoster-like rash |
|
| Mumps-like illness |
|