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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_538 |
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Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot
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This study will compare ProQuadâ„¢ and concomitant administration of M-M-Râ„¢ II and Varivaxâ„¢ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuadâ„¢ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-Râ„¢ II and Varivaxâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProQuadâ„¢ | Experimental |
| |
| M-M-Râ„¢ II and Varivaxâ„¢ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuadâ„¢) | Biological | Single administration of 0.5 mL subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL | Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | 6 weeks postvaccination |
| Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL | Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline | 6 weeks postvaccination |
| Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL | Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | 6 weeks postvaccination |
| Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline | 6 weeks postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Measles Antibodies | Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | 6 weeks postvaccination |
| Geometric Mean Titer of Mumps Antibodies |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Measles-like Rash | Through 6 weeks postvaccination | |
| Percentage of Participants With Varicella-like Rash | Through 6 weeks postvaccination | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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The study was planned to enroll 360 participants; however the study was terminated early because it was not possible to complete enrollment before expiration of the investigational vaccine lot
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| ID | Title | Description |
|---|---|---|
| FG000 | ProQuadâ„¢ | Single subcutaneous 0.5 mL vaccination |
| FG001 | M-M-Râ„¢ II and Varivaxâ„¢ | Single subcutaneous 0.5 mL vaccination |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | ProQuadâ„¢ | Single subcutaneous 0.5 mL vaccination |
| BG001 | M-M-Râ„¢ II and Varivaxâ„¢ | Single subcutaneous 0.5 mL vaccination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 With Measles Antibody Levels ≥255 mIU/mL | Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | 6 weeks postvaccination |
|
Through 28 days postvaccination
The safety population included all participants who received study vaccination
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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„¢ | Single subcutaneous 0.5 mL vaccination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA 14.1 | Systematic Assessment |
Formal testing of the study hypotheses was not possible because of low enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| 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 |
Not provided
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| ID | Term |
|---|---|
| C050102 | measles, mumps, rubella, varicella vaccine |
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| M-M-Râ„¢ II and Varivaxâ„¢ | Biological | Single administration of 0.5 mL subcutaneous injection |
|
Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
| 6 weeks postvaccination |
| Geometric Mean Titer of Rubella Antibodies | Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | 6 weeks postvaccination |
| Geometric Mean Titer of VZV (gpELISA) Antibodies | Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline | 6 weeks postvaccination |
| Percentage of Participants With Rubella-like Rash |
| Through 6 weeks postvaccination |
| Percentage of Participants With Zoster-like Rash | Through 6 weeks postvaccination |
| Percentage of Participants With Any Systemic Adverse Experience | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences. | Through 6 weeks postvaccination |
| Percentage of Participants With Injection-site Adverse Experiences | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only. | Through 6 weeks postvaccination |
| Percentage of Participants With Injection-site Adverse Experiences | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only. | Through 5 days postvaccination |
| Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal) | Through 6 weeks postvaccination |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Single subcutaneous 0.5 mL vaccination |
|
|
| Primary | Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL | Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | 6 weeks postvaccination |
|
|
|
| Primary | Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL | Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | 6 weeks postvaccination |
|
|
|
| Primary | Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Number | 90% Confidence Interval | percentage of participants | 6 weeks postvaccination |
|
|
|
| Secondary | Geometric Mean Titer of Measles Antibodies | Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | mIU/mL | 6 weeks postvaccination |
|
|
|
| Secondary | Geometric Mean Titer of Mumps Antibodies | Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | Units/mL | 6 weeks postvaccination |
|
|
|
| Secondary | Geometric Mean Titer of Rubella Antibodies | Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | IU/mL | 6 weeks postvaccination |
|
|
|
| Secondary | Geometric Mean Titer of VZV (gpELISA) Antibodies | Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline | Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure. | Posted | Geometric Mean | 90% Confidence Interval | gpELISA units/mL | 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Measles-like Rash | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Varicella-like Rash | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Rubella-like Rash | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Zoster-like Rash | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Any Systemic Adverse Experience | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences. | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Injection-site Adverse Experiences | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only. | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Injection-site Adverse Experiences | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only. | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 5 days postvaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal) | The safety population included all participants who received study vaccination | Posted | Number | percentage of participants | Through 6 weeks postvaccination |
|
|
|
| 0 |
| 13 |
| 8 |
| 13 |
| EG001 | M-M-Râ„¢ II and Varivaxâ„¢ | Single subcutaneous 0.5 mL vaccination | 1 | 16 | 9 | 16 |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| 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 |
| D045424 |
| Complex Mixtures |