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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_627 |
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This study will assess the safety and tolerability of RotaTeqâ„¢ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeqâ„¢/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I - RotaTeqâ„¢, Adults | Experimental | Adults randomized to receive a single dose of RotaTeqâ„¢. |
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| Cohort I - Placebo, Adults | Placebo Comparator | Adults randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
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| Cohort II - RotaTeqâ„¢, Children | Experimental | Children randomized to receive a single dose of RotaTeqâ„¢. |
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| Cohort II - Placebo, Children | Placebo Comparator | Children randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
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| Cohort III - RotaTeqâ„¢, Infants | Experimental | Infants randomized to receive 3 doses of RotaTeqâ„¢. |
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| Cohort III - Placebo, Infants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | Single 2.0 mL dose V260 (RotaTeqâ„¢) administered orally at enrollment. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events. | up to 14 days post vaccination |
| Number of Serious Adverse Events | The total number of serious adverse experiences (events) in participants up to 14 days post vaccination. | 14 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants With Fecal Vaccine Virus Shedding | Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose. |
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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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A total of 144 participants were enrolled; 48 in each of 3 cohorts. This study was conducted sequentially in the 3 different Cohorts, Chinese adults (Cohort I) first, followed by children (Cohort II), and then infants (Cohort III).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort I - RotaTeqâ„¢, Adults | Adults randomized to receive a single dose of RotaTeqâ„¢. |
| FG001 | Cohort I - Placebo, Adults | Adults randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
| FG002 | Cohort II - RotaTeqâ„¢, Children | Children randomized to receive a single dose of RotaTeqâ„¢. |
| FG003 | Cohort II - Placebo, Children | Children randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
| FG004 | Cohort III - RotaTeqâ„¢, Infants | Infants randomized to receive 3 doses of RotaTeqâ„¢. |
| FG005 | Cohort III - Placebo, Infants | Infants randomized to receive 3 doses of matching placebo to RotaTeqâ„¢. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort I - RotaTeqâ„¢, Adults | Adults randomized to receive a single dose of RotaTeqâ„¢. |
| BG001 | Cohort I - Placebo, Adults | Adults randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | The inclusion criterion for Cohort I (adults) in this study was 19-47 years. However, one participant who was 49 years at study entry was randomized. |
| 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 | Number of Participants With Serious Adverse Events | All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events. | Posted | Number | Participants | up to 14 days post vaccination |
|
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One participant in the Cohort III-RotaTeqâ„¢ treatment group received RotaTeqâ„¢ at the first and third dose but placebo at the second dose in error. The participant had moderate or mild diarrhea after the second and third doses, respectively. The participant's AE data is included in the AE tables under the Cohort III-RotaTeqâ„¢ treatment group.
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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 | Cohort I - RotaTeqâ„¢, Adults | Adults randomized to receive a single dose of RotaTeqâ„¢. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp and Dohme | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| C492535 | RotaTeq |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Infants randomized to receive 3 doses of matching placebo to RotaTeqâ„¢. |
|
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| Comparator: Placebo | Biological | Single 2.0 mL dose of matching placebo to RotaTeqâ„¢ administered orally at enrollment. |
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| Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | Three 2.0 mL doses of RotaTeqâ„¢ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses. |
|
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| Comparator: Placebo | Biological | Three 2.0 mL doses of matching placebo to RotaTeqâ„¢ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age. |
|
| Between Day 3 and Day 7 following each of 3 doses of RotaTeqâ„¢/placebo |
| Serious Adverse Event |
|
| BG002 | Cohort II - RotaTeqâ„¢, Children | Children randomized to receive a single dose of RotaTeqâ„¢. |
| BG003 | Cohort II - Placebo, Children | Children randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
| BG004 | Cohort III - RotaTeqâ„¢, Infants | Infants randomized to receive 3 doses of RotaTeqâ„¢. |
| BG005 | Cohort III - Placebo, Infants | Infants randomized to receive 3 doses of matching placebo to RotaTeqâ„¢. |
| BG006 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Children randomized to receive a single dose of RotaTeqâ„¢. |
| OG003 | Cohort II - Placebo, Children | Children randomized to receive a single dose of matching placebo to RotaTeqâ„¢. |
| OG004 | Cohort III - RotaTeqâ„¢, Infants | Infants randomized to receive 3 doses of RotaTeqâ„¢. |
| OG005 | Cohort III - Placebo, Infants | Infants randomized to receive 3 doses of matching placebo to RotaTeqâ„¢. |
|
|
| Primary | Number of Serious Adverse Events | The total number of serious adverse experiences (events) in participants up to 14 days post vaccination. | Posted | Number | Events | 14 days post vaccination |
|
|
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| Secondary | Number of Infants With Fecal Vaccine Virus Shedding | Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose. | Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose. | Posted | Number | Participants | Between Day 3 and Day 7 following each of 3 doses of RotaTeqâ„¢/placebo |
|
|
|
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | Cohort I - Placebo, Adults | Adults randomized to receive a single dose of matching placebo to RotaTeqâ„¢. | 0 | 24 | 2 | 24 |
| EG002 | Cohort II - RotaTeqâ„¢, Children | Children randomized to receive a single dose of RotaTeqâ„¢. | 0 | 24 | 6 | 24 |
| EG003 | Cohort II - Placebo, Children | Children randomized to receive a single dose of matching placebo to RotaTeqâ„¢. | 0 | 24 | 3 | 24 |
| EG004 | Cohort III - RotaTeqâ„¢, Infants | Infants randomized to receive 3 doses of RotaTeqâ„¢. | 0 | 24 | 18 | 24 |
| EG005 | Cohort III - Placebo, Infants | Infants randomized to receive 3 doses of matching placebo to RotaTeqâ„¢. | 3 | 24 | 14 | 24 |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| ENCEPHALITIS VIRAL | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 12.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 12.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | 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. SPONSOR review can be expedited to meet publication guidelines.
| Postdose 3 (n=22 for RotaTeqâ„¢, n=20 for placebo) |
|