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A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeqâ„¢ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RotaTeq™ Experimental Formulation | Experimental | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days) |
|
| RotaTeq™ Existing Formulation | Active Comparator | Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RotaTeqâ„¢ experimental formulation | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | 42 days after vaccination 3 (up to 185 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability | An adverse event 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 vaccine, 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 vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability. |
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Inclusion Criteria:
Exclusion Criteria:
Combined Immunodeficiency (SCID)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28141698 | Result | Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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A total of 1039 participants were screened
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ Experimental Formulation | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| FG001 | RotaTeq™ Existing Formulation | Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ Experimental Formulation | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| BG001 |
| 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 | Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint | Posted | Geometric Mean | 95% Confidence Interval | Titer | 42 days after vaccination 3 (up to 185 days) |
|
All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185
The participants at risk includes participants who received at least one dose of study vaccine and had follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RotaTeq™ Experimental Formulation | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 17.0 | 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 |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| RotaTeqâ„¢ existing formulation |
| Biological |
|
|
| Up to 7 days after any vaccination (up to 147 days) |
| Number of Participants With Tier-1 Adverse Events: Intussusception | The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception | Up to Day 185 |
| Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A | 42 days after vaccination 3 (up to 185 days) |
| Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Baseline and 42 days after vaccination 3 (up to 185 days) |
| Withdrawal by parent/guardian |
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| Physician Decision |
|
| Randomized but not vaccinated |
|
| RotaTeqâ„¢ Existing Formulation |
Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
|
|
|
| Secondary | Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability | An adverse event 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 vaccine, 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 vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability. | Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose. | Posted | Number | Participants | Up to 7 days after any vaccination (up to 147 days) |
|
|
|
| Secondary | Number of Participants With Tier-1 Adverse Events: Intussusception | The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception | Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose. | Posted | Number | Participants | Up to Day 185 |
|
|
|
| Secondary | Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A | Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint | Posted | Geometric Mean | 95% Confidence Interval | Titer | 42 days after vaccination 3 (up to 185 days) |
|
|
|
| Secondary | Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] | Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 42 days after vaccination 3 (up to 185 days) |
|
|
|
| 20 |
| 508 |
| 398 |
| 508 |
| EG001 | RotaTeq™ Existing Formulation | Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). | 12 | 499 | 385 | 499 |
| Umbilical hernia | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 17.0 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Parainfluenzae virus infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
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| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
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| Hypersomnia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 17.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
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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.
| Elevated temperature |
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| Irritability |
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| Serotype G3 |
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| Serotype G4 |
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| Serotype P1A[8] |
|