Trial Outcomes & Findings for A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) (NCT NCT00953056)
NCT ID: NCT00953056
Last Updated: 2015-11-02
Results Overview
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
144 participants
Primary outcome timeframe
up to 14 days post vaccination
Results posted on
2015-11-02
Participant Flow
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).
Participant milestones
| Measure |
Cohort I - RotaTeq™, Adults
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
24
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Cohort I - RotaTeq™, Adults
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
2
|
3
|
|
Overall Study
Serious Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Cohort I - RotaTeq™, Adults
n=24 Participants
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 Participants
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
n=24 Participants
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
n=24 Participants
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
n=24 Participants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
n=24 Participants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
6 weeks to 12 weeks (infants)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
24 participants
n=21 Participants
|
24 participants
n=8 Participants
|
48 participants
n=8 Participants
|
|
Age, Customized
2 years to 5 years (children)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
24 participants
n=5 Participants
|
24 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
48 participants
n=8 Participants
|
|
Age, Customized
19 years to 49 years (adults)
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
48 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
74 Participants
n=8 Participants
|
|
Region of Enrollment
China
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
24 participants
n=5 Participants
|
24 participants
n=4 Participants
|
24 participants
n=21 Participants
|
24 participants
n=8 Participants
|
144 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 14 days post vaccinationAll serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Outcome measures
| Measure |
Cohort I - RotaTeq™, Adults
n=24 Participants
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 Participants
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
n=24 Participants
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
n=24 Participants
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
n=24 Participants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
n=24 Participants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 14 days post vaccinationThe total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
Outcome measures
| Measure |
Cohort I - RotaTeq™, Adults
n=24 Participants
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 Participants
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
n=24 Participants
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
n=24 Participants
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
n=24 Participants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
n=24 Participants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
4 Events
|
SECONDARY outcome
Timeframe: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placeboPopulation: 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.
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.
Outcome measures
| Measure |
Cohort I - RotaTeq™, Adults
n=24 Participants
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 Participants
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Number of Infants With Fecal Vaccine Virus Shedding
Postdose 1 (n=23 for RotaTeq™, n=24 for placebo)
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Infants With Fecal Vaccine Virus Shedding
Postdose 2 (n=21 for RotaTeq™, n=22 for placebo)
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Infants With Fecal Vaccine Virus Shedding
Postdose 3 (n=22 for RotaTeq™, n=20 for placebo)
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort I - RotaTeq™, Adults
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort I - Placebo, Adults
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort II - RotaTeq™, Children
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort II - Placebo, Children
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort III - RotaTeq™, Infants
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort III - Placebo, Infants
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort I - RotaTeq™, Adults
n=24 participants at risk
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 participants at risk
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
n=24 participants at risk
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
n=24 participants at risk
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
n=24 participants at risk
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
n=24 participants at risk
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 2
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Infections and infestations
ENCEPHALITIS VIRAL
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
Other adverse events
| Measure |
Cohort I - RotaTeq™, Adults
n=24 participants at risk
Adults randomized to receive a single dose of RotaTeq™.
|
Cohort I - Placebo, Adults
n=24 participants at risk
Adults randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort II - RotaTeq™, Children
n=24 participants at risk
Children randomized to receive a single dose of RotaTeq™.
|
Cohort II - Placebo, Children
n=24 participants at risk
Children randomized to receive a single dose of matching placebo to RotaTeq™.
|
Cohort III - RotaTeq™, Infants
n=24 participants at risk
Infants randomized to receive 3 doses of RotaTeq™.
|
Cohort III - Placebo, Infants
n=24 participants at risk
Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 2
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
54.2%
13/24 • Number of events 23
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
33.3%
8/24 • Number of events 19
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
37.5%
9/24 • Number of events 22
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
50.0%
12/24 • Number of events 25
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
General disorders
MALAISE
|
8.3%
2/24 • Number of events 2
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
General disorders
PYREXIA
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
16.7%
4/24 • Number of events 4
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
8.3%
2/24 • Number of events 2
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
37.5%
9/24 • Number of events 11
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
20.8%
5/24 • Number of events 8
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Infections and infestations
NASOPHARYNGITIS
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
8.3%
2/24 • Number of events 3
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
8.3%
2/24 • Number of events 4
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Nervous system disorders
HEADACHE
|
8.3%
2/24 • Number of events 3
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
0.00%
0/24
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
4.2%
1/24 • Number of events 1
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
8.3%
2/24 • Number of events 2
One participant in the Cohort III-RotaTeq™ treatment group received RotaTeq™ 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-RotaTeq™ treatment group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER