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| ID | Type | Description | Link |
|---|---|---|---|
| F05-MMRV-304 | Other Identifier | MCMVaccBV (SPMSD) Protocol Number | |
| 2006-001986-40 | EudraCT Number |
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Primary objective:
To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular ProQuad® | Experimental | Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. |
|
| Subcutaneous ProQuad® | Active Comparator | Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProQuad® | Biological | Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. 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 rates were determined 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. | Week 10 (6 weeks after Dose 2 on Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne FIQUET, MD | SPMSD | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30481110 | Derived | Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8. |
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A total of 411 male and female participants (12 to 18 months of age) were selected for study entry at 33 sites in France. A total of 405 participants were randomized and received 2 doses of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intramuscular ProQuad® | Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days. |
| FG001 | Subcutaneous ProQuad® | Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intramuscular ProQuad® | Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days. |
| BG001 | Subcutaneous ProQuad® |
| 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 Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment | Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. 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 rates were determined 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. | Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 10 (6 weeks after Dose 2 on Week 4) |
|
Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).
An AE 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. Event data are presented separately for Dose 1 and Dose 2.
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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 | IM ProQuad® Arm: Dose 1 | All participants who received the first dose of ProQuad® via IM injection are included. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | 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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| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
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| Week 4 |
| Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. | Week 4 |
| Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL. | Week 4 |
| Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. | Week 4 |
| Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. | Week 4 |
| Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. | Week 10 (6 weeks after Dose 2 on Week 4) |
| Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL. | Week 10 (6 weeks after Dose 2 on Week 4) |
| Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. | Week 10 (6 weeks after Dose 2 on Week 4) |
| Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. | Week 10 (6 weeks after Dose 2 on Week 4) |
| Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | An AE 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. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. | From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose) |
| Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. | From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose) |
| Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. | From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose) |
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Intramuscular ProQuad® |
Participants received both doses (given on Day 1 and Week 4) of ProQuad® by IM injection into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Doses were separated by 30 to 44 days. |
| OG001 | Subcutaneous ProQuad® | Participants received both doses (given on Day 1 and Week 4) of ProQuad® by SC injection in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Doses were separated by 30 to 44 days. |
|
|
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| Secondary | Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose | Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined 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. | Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
|
|
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| Secondary | Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose | Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. | Participants who were initially seronegative to measles and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (mIU/mL) | Week 4 |
|
|
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| Secondary | Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose | Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL. | Participants who were initially seronegative to mumps and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (ELISA Ab units/mL) | Week 4 |
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|
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| Secondary | Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose | Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. | Participants who were initially seronegative to rubella and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (IU/mL) | Week 4 |
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|
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| Secondary | Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose | Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. | Participants who were initially seronegative to varicella and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (gpELISA units/mL) | Week 4 |
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| Secondary | Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL. | Participants who were initially seronegative to measles and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (mIU/mL) | Week 10 (6 weeks after Dose 2 on Week 4) |
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|
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| Secondary | Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL. | Participants who were initially seronegative to mumps and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (ELISA Ab units/mL) | Week 10 (6 weeks after Dose 2 on Week 4) |
|
|
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| Secondary | Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL. | Participants who were initially seronegative to rubella and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (IU/mL) | Week 10 (6 weeks after Dose 2 on Week 4) |
|
|
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| Secondary | Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment | Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL. | Participants who were initially seronegative to varicella and who had post-vaccination serology results were included. | Posted | Geometric Mean | 95% Confidence Interval | Antibody titres (gpELISA units/mL) | Week 10 (6 weeks after Dose 2 on Week 4) |
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| Secondary | Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose | An AE 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. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. | All participants who received at least one dose of study drug and had safety follow-up data are included. | Posted | Number | Percentage of participants | From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose) |
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|
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| Secondary | Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose | An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest. | All participants who received at least one dose of study drug and had safety follow-up data are included. | Posted | Number | Percentage of participants | From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose) |
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| Secondary | Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose | An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. | Posted | Number | Percentage of participants | From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose) |
|
|
|
| 2 |
| 202 |
| 153 |
| 202 |
| EG001 | SC ProQuad® Arm: Dose 1 | All participants who received the first dose of ProQuad® via SC injection are included. | 2 | 203 | 166 | 203 |
| EG002 | IM ProQuad® Arm: Dose 2 | All participants who received the second dose of ProQuad® via IM injection are included. | 1 | 201 | 141 | 201 |
| EG003 | SC ProQuad® Arm: Dose 2 | All participants who received the second dose of ProQuad® via SC injection are included. | 1 | 200 | 137 | 200 |
| Gastroenteritis viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Viral tonsillitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA v.10.0 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA v.10.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v.10.0 | Systematic Assessment |
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| Tracheitis | Infections and infestations | MedDRA v.10.0 | Systematic Assessment |
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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 |
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| Rubella |
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| Varicella |
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