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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_537 |
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Strategic business decision not to pursue indication due to lack of demonstrable medical need
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This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60 subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other regulatory agencies. Duration for the entire study will be approximately 4 years.
Note: As the result of a business decision by the Sponsor, the study did not proceed with Part II. Therefore, this report includes the results for Part I only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I, RotaTeq | Experimental | 3 doses of RotaTeq |
|
| Part I, placebo | Placebo Comparator | 3 doses of placebo |
|
| Part II, RotaTeq | Experimental | 3 doses of RotaTeq |
|
| Part II, RotaTeq and placebo | Experimental | 1 dose of RotaTeq and 2 doses of placebo |
|
| Part II, placebo | Placebo Comparator | 3 doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: RotaTeq | Biological | Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. | Up to 42 days following any dose of RotaTeq™ or placebo |
| Part I: Number of Participants With Serious Adverse Experiences (SAEs) | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose. | Up to 180 days following the third dose of RotaTeq™ or placebo |
| Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo. | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
| Part II: Number of Participants With Nonserious Adverse Experiences | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Up to 42 days following any dose of RotaTeq™ and/or placebo |
| Part II: Number of Participants With Serious Adverse Experiences |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25424929 | Result | Lawrence J, He S, Martin J, Schodel F, Ciarlet M, Murray AV. Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects. Hum Vaccin Immunother. 2014;10(8):2247-54. doi: 10.4161/hv.29107. |
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Part II was not conducted; no participants were recruited.
Enrollment of participants occurred at 8 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeq™ | Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
| FG001 | Placebo | Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeq™ | Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Between 65 and 80 years. |
| 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 | Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. | All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries. Number of participants with one or more adverse experience. | Posted | Number | participants | Up to 42 days following any dose of RotaTeq™ or placebo |
|
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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™ | Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 12.2 | Systematic Assessment | Reported within the 43-180 days post vaccination 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.2 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Late Stage Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
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| Comparator: Placebo | Biological | Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
|
| Comparator: RotaTeq + Placebo | Biological | One 2.0 mL oral dose of RotaTeq and two 2.0 mL oral doses of placebo over an approximately 3-5 month treatment period |
|
Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
| Up to 180 days following the third dose of RotaTeq™ and/or placebo |
| Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
| Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
| Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
| Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
| Withdrawal by Subject |
|
Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. |
|
|
| Primary | Part I: Number of Participants With Serious Adverse Experiences (SAEs) | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose. | All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries. Number of participants with one or more adverse experience. | Posted | Number | participants | Up to 180 days following the third dose of RotaTeq™ or placebo |
|
|
|
| Primary | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo. | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
|
|
| Primary | Part II: Number of Participants With Nonserious Adverse Experiences | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Posted | Up to 42 days following any dose of RotaTeq™ and/or placebo |
|
|
| Primary | Part II: Number of Participants With Serious Adverse Experiences | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Posted | Up to 180 days following the third dose of RotaTeq™ and/or placebo |
|
|
| Secondary | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
|
|
| Secondary | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
|
|
| Primary | Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Posted | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
|
|
| Secondary | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
|
|
| Secondary | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
|
|
| Secondary | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations. Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators. | Posted | Geometric Mean | 95% Confidence Interval | titers | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo |
|
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| Secondary | Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Posted | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
|
|
| Secondary | Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A | Part II was not conducted due to study termination; this report summarizes study results from Part I only. | Posted | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 |
|
|
| 2 |
| 44 |
| 18 |
| 44 |
| EG001 | Placebo | Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. | 0 | 22 | 4 | 22 |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.2 | Systematic Assessment | Reported within the 42-day period post vaccination 1 |
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| Nausea | Gastrointestinal disorders | MedDRA 12.2 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.2 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.2 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.2 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.2 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.2 | Systematic Assessment |
|
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| Postdose 2 GMT (n=37 RotaTeq/ n=20 placebo) |
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| Postdose 3 GMT (n=38 RotaTeq/ n=18 placebo) |
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| Postdose 2 GMT (n=37 RotaTeq/ n=20 Placebo) |
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| Postdose 3 GMT (n=38 RotaTeq/ n=18 Placebo) |
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| Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) |
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| Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) |
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| Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) |
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| Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) |
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| Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) |
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| Postdose 3 GMT (n= 3 RotaTeq/ n=18 placebo) |
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| Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) |
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| Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) |
|