Gastroenteritis, Rotavirus
Conditions
Keywords
Gastroenteritis, Rotavirus
Brief summary
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
Interventions
BIOLOGICALRotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Rotateq orally administered 3 times
Placebo orally administered 3 times
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age
Exclusion criteria
* History Of Known Prior Rotavirus Gastroenteritis * Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | At least 14 days following the 3rd vaccination | Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | At least 14 days following the 3rd vaccination | Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe. |
| Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | At least 14 days following the 3rd vaccination | Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe. |
Participant flow
Recruitment details
The study was conducted at 32 sites in Japan from 2008 to 2009.
Pre-assignment details
Excluded from the trial before assignment to groups were subjects with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive; immune impairment or resides in a household with an individual with an immune impairment.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. | 381 |
| Placebo Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study. | 381 |
| Total | 762 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 10 |
Baseline characteristics
| Characteristic | RotaTeq™ | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 7.6 Weeks STANDARD_DEVIATION 1.7 | 7.5 Weeks STANDARD_DEVIATION 1.6 | 7.5 Weeks STANDARD_DEVIATION 1.6 |
| Age, Customized 6 to 12 Weeks of age | 381 participants | 381 participants | 762 participants |
| Sex: Female, Male Female | 173 Participants | 182 Participants | 355 Participants |
| Sex: Female, Male Male | 208 Participants | 199 Participants | 407 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 179 / 380 | 175 / 381 |
| serious Total, serious adverse events | 7 / 380 | 9 / 381 |
Outcome results
Primary
Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition
Time frame: At least 14 days following the 3rd vaccination
Population: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 7 Number of participants |
| Placebo | Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 27 Number of participants |
p-value: <0.00195% CI: [39.9, 90.6]Exact Conditional Test
Secondary
Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.
Time frame: At least 14 days following the 3rd vaccination
Population: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 5 Number of participants |
| Placebo | Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 25 Number of participants |
p-value: <0.00195% CI: [47.4, 94.1]Exact Conditional Test
Secondary
Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of \>8 and \<=16 was considered moderate, and \>16 was considered severe.
Time frame: At least 14 days following the 3rd vaccination
Population: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 0 Number of participants |
| Placebo | Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A | 10 Number of participants |
p-value: <0.00195% CI: [55.4, 100]Exact Conditional Test