Trial Outcomes & Findings for Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants (NCT NCT00241644)
NCT ID: NCT00241644
Last Updated: 2016-12-09
Results Overview
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2089 participants
Primary outcome timeframe
From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Results posted on
2016-12-09
Participant Flow
Only subjects from Malawi and from Cohort 2 South Africa were asked to continue the study for a second follow-up period (Year 2).
Of the total of 4941 subjects enrolled in this study, 2 subjects were allocated a subject number but did not get any study vaccine administered. Hence, only 4939 subjects were considered as 'started'. For the second follow-up period, as mentioned in the protocol the results are presented for Rotarix Pooled and Placebo Groups only.
Participant milestones
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Placebo Group
Subjects received 3 doses of placebo.
|
Rotarix Pooled Group
Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
|
|---|---|---|---|---|
|
First Efficacy Period (Year 1)
STARTED
|
1647
|
1651
|
1641
|
3298
|
|
First Efficacy Period (Year 1)
COMPLETED
|
1420
|
1383
|
1392
|
2803
|
|
First Efficacy Period (Year 1)
NOT COMPLETED
|
227
|
268
|
249
|
495
|
|
Second Efficacy Period (Year 2)
STARTED
|
771
|
754
|
746
|
1525
|
|
Second Efficacy Period (Year 2)
COMPLETED
|
710
|
697
|
682
|
1407
|
|
Second Efficacy Period (Year 2)
NOT COMPLETED
|
61
|
57
|
64
|
118
|
Reasons for withdrawal
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Placebo Group
Subjects received 3 doses of placebo.
|
Rotarix Pooled Group
Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
|
|---|---|---|---|---|
|
First Efficacy Period (Year 1)
Adverse Event
|
46
|
45
|
45
|
91
|
|
First Efficacy Period (Year 1)
Protocol Violation
|
3
|
5
|
4
|
8
|
|
First Efficacy Period (Year 1)
Withdrawal by Subject
|
59
|
74
|
81
|
133
|
|
First Efficacy Period (Year 1)
Lost to Follow-up
|
116
|
142
|
116
|
258
|
|
First Efficacy Period (Year 1)
Non-compliance
|
2
|
1
|
2
|
3
|
|
First Efficacy Period (Year 1)
Return dates not reliable
|
1
|
0
|
0
|
1
|
|
First Efficacy Period (Year 1)
Vaccinated at regular clinic
|
0
|
0
|
1
|
0
|
|
First Efficacy Period (Year 1)
Subject's parent passed away
|
0
|
1
|
0
|
1
|
|
Second Efficacy Period (Year 2)
Adverse Event
|
11
|
9
|
12
|
20
|
|
Second Efficacy Period (Year 2)
Protocol Violation
|
2
|
1
|
2
|
3
|
|
Second Efficacy Period (Year 2)
Withdrawal by Subject
|
4
|
3
|
2
|
7
|
|
Second Efficacy Period (Year 2)
Lost to Follow-up
|
43
|
43
|
46
|
86
|
|
Second Efficacy Period (Year 2)
Consenting parent passed away
|
1
|
1
|
2
|
2
|
Baseline Characteristics
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
Baseline characteristics by cohort
| Measure |
Rotarix 2-dose Group
n=1647 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1651 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Placebo Group
n=1641 Participants
Subjects received 3 doses of placebo.
|
Rotarix Pooled Group
n=3298 Participants
Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
|
Total
n=8237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.3 weeks
STANDARD_DEVIATION 0.92 • n=5 Participants
|
6.4 weeks
STANDARD_DEVIATION 0.98 • n=7 Participants
|
6.4 weeks
STANDARD_DEVIATION 0.97 • n=5 Participants
|
6.4 weeks
STANDARD_DEVIATION 0.95 • n=4 Participants
|
6.4 weeks
STANDARD_DEVIATION 0.95 • n=21 Participants
|
|
Gender
Female
|
811 Participants
n=5 Participants
|
839 Participants
n=7 Participants
|
800 Participants
n=5 Participants
|
1650 Participants
n=4 Participants
|
4100 Participants
n=21 Participants
|
|
Gender
Male
|
836 Participants
n=5 Participants
|
812 Participants
n=7 Participants
|
841 Participants
n=5 Participants
|
1648 Participants
n=4 Participants
|
4137 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of agePopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1496 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1478 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2974 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1443 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
|
30 subjects
|
26 subjects
|
56 subjects
|
70 subjects
|
SECONDARY outcome
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of agePopulation: Analysis was performed on the ATP cohort for efficacy
Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. Rotavirus types were G1 wild type (WT) and non-G1.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1496 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1478 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2974 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1443 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type
G1 WT
|
8 subjects
|
9 subjects
|
17 subjects
|
23 subjects
|
|
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type
Non-G1
|
22 subjects
|
17 subjects
|
39 subjects
|
47 subjects
|
SECONDARY outcome
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of agePopulation: Analysis was performed on the ATP cohort for efficacy
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1496 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1478 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2974 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1443 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
|
93 subjects
|
74 subjects
|
167 subjects
|
174 subjects
|
SECONDARY outcome
Timeframe: From the first vaccine or placebo dose up to 1 year of ageNumber of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1647 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1651 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=3298 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1641 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
|
37 subjects
|
31 subjects
|
68 subjects
|
83 subjects
|
SECONDARY outcome
Timeframe: From 2 weeks after the third dose of vaccine or placebo up to 1 year of agePopulation: Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season. For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group).
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=478 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=468 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=946 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=468 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain
|
5 subjects
|
3 subjects
|
8 subjects
|
20 subjects
|
SECONDARY outcome
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of agePopulation: Analysis was performed on the ATP cohort for efficacy.
Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1496 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1478 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2974 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1443 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Severe Gastroenteritis of Any Cause
|
134 subjects
|
122 subjects
|
256 subjects
|
178 subjects
|
SECONDARY outcome
Timeframe: From 2 weeks after the last vaccine or placebo dose up to 1 year of agePopulation: Analysis was performed on the ATP cohort for efficacy
RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1496 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1478 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2974 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1443 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
|
78 subjects
|
64 subjects
|
142 subjects
|
156 subjects
|
SECONDARY outcome
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study endPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1873 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=891 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains
|
—
|
—
|
81 subjects
|
66 subjects
|
SECONDARY outcome
Timeframe: During the period from 1 year of age to study endPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1500 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=712 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains
|
—
|
—
|
35 subjects
|
21 subjects
|
SECONDARY outcome
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study endPopulation: The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.
RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1873 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=891 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains
|
—
|
—
|
159 subjects
|
118 subjects
|
SECONDARY outcome
Timeframe: During the period from 1 year of age to study endPopulation: The analysis was performed on the ATP cohort for efficacy of the second efficacy period.
RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1500 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=712 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains
|
—
|
—
|
58 subjects
|
26 subjects
|
SECONDARY outcome
Timeframe: During the period from 2 weeks after the last dose of vaccine or placebo until study endPopulation: The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. Rotavirus types were G1 wild type (WT) and non-G1.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1873 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=891 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type
G1 WT
|
—
|
—
|
21 subjects
|
20 subjects
|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type
Non-G1
|
—
|
—
|
60 subjects
|
48 subjects
|
SECONDARY outcome
Timeframe: During the period from 1 year of age to study endPopulation: The analysis was performed on the ATP cohort for efficacy of the second efficacy period.
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system. Rotavirus types were G1 wild type (WT) and non-G1.
Outcome measures
| Measure |
Rotarix 2-dose Group
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=1500 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=712 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type
G1 WT
|
—
|
—
|
10 subjects
|
11 subjects
|
|
For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type
Non-G1
|
—
|
—
|
25 subjects
|
10 subjects
|
SECONDARY outcome
Timeframe: From the first dose of vaccine or placebo up to end of the studyAn AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1647 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1651 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=3298 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1641 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out
|
57 subjects
|
54 subjects
|
111 subjects
|
56 subjects
|
SECONDARY outcome
Timeframe: From the first dose of vaccine or placebo up to end of the studyAn SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1647 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1651 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=3298 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1641 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
222 subjects
|
199 subjects
|
421 subjects
|
246 subjects
|
SECONDARY outcome
Timeframe: One month after the last vaccine dosePopulation: Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.
An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=106 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=115 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=221 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=111 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects
|
56.6 Units per milliliter (U/mL)
Interval 38.9 to 82.3
|
79.4 Units per milliliter (U/mL)
Interval 54.7 to 115.2
|
67.5 Units per milliliter (U/mL)
Interval 51.9 to 87.8
|
23.4 Units per milliliter (U/mL)
Interval 16.8 to 32.5
|
SECONDARY outcome
Timeframe: One month after the last vaccine or placebo dosePopulation: Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.
Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=106 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=115 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=221 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=111 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects
|
57 subjects
|
72 subjects
|
129 subjects
|
25 subjects
|
SECONDARY outcome
Timeframe: One month after the last vaccine or placebo dosePopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given as Units per milliliter (U/mL).
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1160 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1138 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2298 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1125 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies
|
72.5 U/mL
Interval 65.2 to 80.6
|
67.9 U/mL
Interval 60.8 to 75.9
|
70.2 U/mL
Interval 65.0 to 75.8
|
21.8 U/mL
Interval 19.8 to 24.0
|
SECONDARY outcome
Timeframe: One month after the last vaccine or placebo dosePopulation: Analysis was performed on the ATP cohort for immunogenicity.
Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.
Outcome measures
| Measure |
Rotarix 2-dose Group
n=1160 Participants
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1138 Participants
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=2298 Participants
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1125 Participants
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects
|
756 subjects
|
706 subjects
|
1462 subjects
|
262 subjects
|
Adverse Events
Rotarix 2-dose Group
Serious events: 222 serious events
Other events: 0 other events
Deaths: 0 deaths
Rotarix 3-dose Group
Serious events: 199 serious events
Other events: 0 other events
Deaths: 0 deaths
Rotarix Pooled Group
Serious events: 421 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 246 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotarix 2-dose Group
n=1647 participants at risk
Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix 3-dose Group
n=1651 participants at risk
Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
|
Rotarix Pooled Group
n=3298 participants at risk
For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group \& Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
|
Placebo Group
n=1641 participants at risk
Subjects received 3 doses of placebo.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.12%
2/1647
|
0.36%
6/1651
|
0.24%
8/3298
|
0.12%
2/1641
|
|
Infections and infestations
Gastroenteritis
|
5.7%
94/1647
|
4.1%
67/1651
|
4.9%
161/3298
|
6.3%
104/1641
|
|
Infections and infestations
Pneumonia
|
3.3%
55/1647
|
3.3%
54/1651
|
3.3%
109/3298
|
3.9%
64/1641
|
|
Infections and infestations
Bronchopneumonia
|
1.8%
29/1647
|
1.5%
25/1651
|
1.6%
54/3298
|
1.5%
25/1641
|
|
Infections and infestations
Sepsis
|
2.0%
33/1647
|
1.7%
28/1651
|
1.8%
61/3298
|
1.8%
29/1641
|
|
Infections and infestations
Bronchiolitis
|
1.3%
21/1647
|
1.0%
17/1651
|
1.2%
38/3298
|
1.0%
17/1641
|
|
Infections and infestations
Malaria
|
1.2%
19/1647
|
1.5%
25/1651
|
1.3%
44/3298
|
2.0%
33/1641
|
|
Infections and infestations
Upper respiratory tract infection
|
0.43%
7/1647
|
0.42%
7/1651
|
0.42%
14/3298
|
0.06%
1/1641
|
|
Infections and infestations
Meningitis
|
0.43%
7/1647
|
0.24%
4/1651
|
0.33%
11/3298
|
0.12%
2/1641
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.24%
4/1647
|
0.24%
4/1651
|
0.24%
8/3298
|
0.30%
5/1641
|
|
Nervous system disorders
Febrile convulsion
|
0.24%
4/1647
|
0.42%
7/1651
|
0.33%
11/3298
|
0.37%
6/1641
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.18%
3/1647
|
0.18%
3/1651
|
0.18%
6/3298
|
0.24%
4/1641
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
3/1647
|
0.18%
3/1651
|
0.18%
6/3298
|
0.12%
2/1641
|
|
Metabolism and nutrition disorders
Kwashiorkor
|
0.18%
3/1647
|
0.24%
4/1651
|
0.21%
7/3298
|
0.49%
8/1641
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.24%
4/1647
|
0.12%
2/1651
|
0.18%
6/3298
|
0.18%
3/1641
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.30%
5/1647
|
0.00%
0/1651
|
0.15%
5/3298
|
0.06%
1/1641
|
|
General disorders
Death
|
0.12%
2/1647
|
0.12%
2/1651
|
0.12%
4/3298
|
0.06%
1/1641
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.18%
3/1641
|
|
Infections and infestations
Oral candidiasis
|
0.12%
2/1647
|
0.06%
1/1651
|
0.09%
3/3298
|
0.18%
3/1641
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
3/1647
|
0.12%
2/1651
|
0.15%
5/3298
|
0.12%
2/1641
|
|
Infections and infestations
Bronchitis
|
0.12%
2/1647
|
0.00%
0/1651
|
0.06%
2/3298
|
0.12%
2/1641
|
|
Infections and infestations
Pneumonia viral
|
0.18%
3/1647
|
0.00%
0/1651
|
0.09%
3/3298
|
0.12%
2/1641
|
|
General disorders
Pyrexia
|
0.06%
1/1647
|
0.18%
3/1651
|
0.12%
4/3298
|
0.24%
4/1641
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.12%
2/1641
|
|
Infections and infestations
Croup infectious
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.06%
1/1641
|
|
Metabolism and nutrition disorders
Marasmus
|
0.18%
3/1647
|
0.30%
5/1651
|
0.24%
8/3298
|
0.24%
4/1641
|
|
Infections and infestations
Otitis media
|
0.12%
2/1647
|
0.06%
1/1651
|
0.09%
3/3298
|
0.06%
1/1641
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Nervous system disorders
Encephalitis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.12%
2/1641
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.12%
2/1647
|
0.00%
0/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.12%
2/1641
|
|
Infections and infestations
Otitis media acute
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.18%
3/1647
|
0.00%
0/1651
|
0.09%
3/3298
|
0.00%
0/1641
|
|
Nervous system disorders
Status epilepticus
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Subcutaneous abscess
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.12%
2/1641
|
|
Infections and infestations
Tonsillitis
|
0.12%
2/1647
|
0.00%
0/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.12%
2/1641
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Nervous system disorders
Convulsion
|
0.06%
1/1647
|
0.12%
2/1651
|
0.09%
3/3298
|
0.18%
3/1641
|
|
Nervous system disorders
Fontanelle bulging
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.18%
3/1641
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.18%
3/1641
|
|
Infections and infestations
Staphylococcal skin infection
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.12%
2/1647
|
0.24%
4/1651
|
0.18%
6/3298
|
0.24%
4/1641
|
|
Infections and infestations
Abscess
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Abscess neck
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Surgical and medical procedures
Adenoidectomy
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Eye disorders
Blindness
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Cerebral malaria
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
General disorders
Cyst
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Eczema infected
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Febrile infection
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Injury, poisoning and procedural complications
Fractured skull depressed
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
2/1647
|
0.00%
0/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Herpes simplex
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.12%
2/1641
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.12%
2/1641
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Metabolism and nutrition disorders
Hyponatraemic syndrome
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Cardiac disorders
Hypovolaemic shock
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Gastrointestinal disorders
Ileus
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Klebsiella bacteremia
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Nosocomial infection
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Parotid abscess
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Pharyngotonsillitis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1647
|
0.12%
2/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Respiratory tract infection viral
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Septic shock
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Cardiac disorders
Tachycardia
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Tuberculosis
|
0.06%
1/1647
|
0.06%
1/1651
|
0.06%
2/3298
|
0.00%
0/1641
|
|
Infections and infestations
Varicella
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Viral tonsillitis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.12%
2/1641
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Empyema
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Grunting
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Immune system disorders
Immunosuppression
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Infection
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
General disorders
Irritability
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
General disorders
Sudden death
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
3/1647
|
0.00%
0/1651
|
0.09%
3/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.06%
1/1641
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Reproductive system and breast disorders
Genital rash
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Keratitis herpetic
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Infections and infestations
skin infection
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1647
|
0.06%
1/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
1/1647
|
0.00%
0/1651
|
0.03%
1/3298
|
0.00%
0/1641
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Infections and infestations
Influenza
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
|
Eye disorders
Strabismus
|
0.00%
0/1647
|
0.00%
0/1651
|
0.00%
0/3298
|
0.06%
1/1641
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER