Trial Outcomes & Findings for A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants. (NCT NCT00432380)
NCT ID: NCT00432380
Last Updated: 2020-01-02
Results Overview
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
375 participants
Primary outcome timeframe
At Month 3
Results posted on
2020-01-02
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Placebo-Rotarix-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
75
|
|
Overall Study
COMPLETED
|
146
|
146
|
74
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
Reasons for withdrawal
| Measure |
Placebo-Rotarix-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Overall Study
Migrated/moved from study area
|
3
|
4
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
Baseline characteristics by cohort
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.6 Weeks
STANDARD_DEVIATION 1.07 • n=5 Participants
|
6.5 Weeks
STANDARD_DEVIATION 1 • n=7 Participants
|
6.6 Weeks
STANDARD_DEVIATION 1.02 • n=5 Participants
|
6.56 Weeks
STANDARD_DEVIATION 1.02 • n=4 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=120 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody
|
84 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=120 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-RV IgA Antibody
|
71 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=120 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=120 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Serum IgA Antibody Concentrations Against Rotavirus
|
68 U/mL
Interval 50.1 to 92.1
|
75.6 U/mL
Interval 52.5 to 109.0
|
—
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across dosesPopulation: The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.
Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (\>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature \> 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature \> 39.5°C or axillary temperature \> 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
Any symptom, Dose 1 [N=150, 150, 75]
|
57 Subjects
|
68 Subjects
|
35 Subjects
|
|
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
Any symptom, Dose 2 [N=149, 147, 75]
|
52 Subjects
|
36 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
Any symptom, Dose 3 [N= 146, 147, 75]
|
29 Subjects
|
38 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
Any symptom, Across doses [N= 150, 150, 75]
|
86 Subjects
|
91 Subjects
|
48 Subjects
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across dosesPopulation: The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.
Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Cough/ runny nose, D1 [N=150, 150, 75]
|
52 Subjects
|
44 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Cough/ runny nose, D1 [N=150, 150, 75]
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Cough/ runny nose, D1 [N=150, 150, 75]
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, D1 [N=150, 150, 75]
|
5 Subjects
|
4 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, D1 [N=150, 150, 75]
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, D1 [N=150, 150, 75]
|
5 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever, D1 [N=150, 150, 75]
|
122 Subjects
|
117 Subjects
|
54 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, D1 [N=150, 150, 75]
|
3 Subjects
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever, D1 [N=150, 150, 75]
|
121 Subjects
|
114 Subjects
|
53 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, D1 [N=150, 150, 75]
|
87 Subjects
|
72 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, D1 [N=150, 150, 75]
|
3 Subjects
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, D1 [N=150, 150, 75]
|
81 Subjects
|
70 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, D1 [N=150, 150, 75]
|
26 Subjects
|
35 Subjects
|
17 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, D1 [N=150, 150, 75]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, D1 [N=150, 150, 75]
|
20 Subjects
|
31 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Vomiting, D1 [N=150, 150, 75]
|
32 Subjects
|
24 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Vomiting, D1 [N=150, 150, 75]
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Vomiting, D1 [N=150, 150, 75]
|
23 Subjects
|
21 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Cough/ runny nose, D2 [N=149, 147, 75]
|
48 Subjects
|
37 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Cough/ runny nose, D2 [N=149, 147, 75]
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Cough/ runny nose, D2 [N=149, 147, 75]
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, D2 [N=149, 147, 75]
|
3 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, D2 [N=149, 147, 75]
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, D2 [N=149, 147, 75]
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever, D2 [N=149, 147, 75]
|
103 Subjects
|
94 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, D2 [N=149, 147, 75]
|
3 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever, D2 [N=149, 147, 75]
|
102 Subjects
|
93 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, D2 [N=149, 147, 75]
|
55 Subjects
|
45 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, D2 [N=149, 147, 75]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, D2 [N=149, 147, 75]
|
52 Subjects
|
43 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, D2 [N=149, 147, 75]
|
20 Subjects
|
21 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, D2 [N=149, 147, 75]
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, D2 [N=149, 147, 75]
|
16 Subjects
|
20 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Vomiting, D2 [N=149, 147, 75]
|
15 Subjects
|
17 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Vomiting, D2 [N=149, 147, 75]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Vomiting, D2 [N=149, 147, 75]
|
11 Subjects
|
14 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Cough/ runny nose, D3 [N=146, 147, 75]
|
36 Subjects
|
31 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Cough/ runny nose, D3 [N=146, 147, 75]
|
0 Subjects
|
6 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Cough/ runny nose, D3 [N=146, 147, 75]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, D3 [N=146, 147, 75]
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, D3 [N=146, 147, 75]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, D3 [N=146, 147, 75]
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever, D3 [N=146, 147, 75]
|
91 Subjects
|
91 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, D3 [N=146, 147, 75]
|
3 Subjects
|
5 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever, D3 [N=146, 147, 75]
|
87 Subjects
|
89 Subjects
|
47 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, D3 [N=146, 147, 75]
|
33 Subjects
|
40 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, D3 [N=146, 147, 75]
|
0 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, D3 [N=146, 147, 75]
|
31 Subjects
|
38 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, D3 [N=146, 147, 75]
|
19 Subjects
|
18 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, D3 [N=146, 147, 75]
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, D3 [N=146, 147, 75]
|
19 Subjects
|
17 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Vomiting, D3 [N=146, 147, 75]
|
10 Subjects
|
8 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Vomiting, D3 [N=146, 147, 75]
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Vomiting, D3 [N=146, 147, 75]
|
8 Subjects
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Cough/runny nose, Across [N=150, 150, 75]
|
82 Subjects
|
69 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Cough/runny nose, Across [N=150, 150, 75]
|
2 Subjects
|
6 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Cough/runny nose, Across [N=150, 150, 75]
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhea, Across [N=150, 150, 75]
|
8 Subjects
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhea, Across [N=150, 150, 75]
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhea, Across [N=150, 150, 75]
|
6 Subjects
|
6 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across [N=150, 150, 75]
|
139 Subjects
|
137 Subjects
|
69 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across [N=150, 150, 75]
|
8 Subjects
|
13 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across [N=150, 150, 75]
|
138 Subjects
|
135 Subjects
|
69 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across [N=150, 150, 75]
|
93 Subjects
|
78 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across [N=150, 150, 75]
|
3 Subjects
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across [N=150, 150, 75]
|
90 Subjects
|
76 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across [N=150, 150, 75]
|
40 Subjects
|
46 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across [N=150, 150, 75]
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across [N=150, 150, 75]
|
35 Subjects
|
42 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Vomiting, Across [N=150, 150, 75]
|
35 Subjects
|
32 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Vomiting, Across [N=150, 150, 75]
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Vomiting, Across [N=150, 150, 75]
|
27 Subjects
|
26 Subjects
|
8 Subjects
|
SECONDARY outcome
Timeframe: From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.
Presence of RV (vaccine strain or wild-type) in GE stools.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes
Between Dose 1 and before Dose 2 [N=150, 150, 75]
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes
Between Dose 2 and before Dose 3 [N=149, 147, 75]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes
Between Dose 3 and Month 3 [N=146, 147, 75]
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes
Between Dose 1 and Month 3 [N=150, 150, 75]
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) period following any study vaccine dose or placeboPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.
An unsolicited AE covers 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Event (AE)
|
53 Subjects
|
60 Subjects
|
19 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to Month 3)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.
Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 Participants
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
Adverse Events
Placebo-Rotarix-Rotarix Group
Serious events: 1 serious events
Other events: 139 other events
Deaths: 0 deaths
Rotarix-Placebo-Rotarix Group
Serious events: 1 serious events
Other events: 137 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
Immune system disorders
Milk allergy
|
0.00%
0/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
0.67%
1/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
0.00%
0/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.67%
1/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
0.00%
0/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
0.00%
0/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Meningitis
|
0.00%
0/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
0.00%
0/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
1.3%
1/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
Other adverse events
| Measure |
Placebo-Rotarix-Rotarix Group
n=150 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Rotarix-Placebo-Rotarix Group
n=150 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
Placebo Group
n=75 participants at risk
Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
|
|---|---|---|---|
|
General disorders
Cough/runny nose
|
54.7%
82/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
46.0%
69/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
53.3%
40/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
General disorders
Diarrhea
|
5.3%
8/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
4.0%
6/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
9.3%
7/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
General disorders
Fever (Rectally)
|
92.7%
139/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
91.3%
137/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
92.0%
69/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
General disorders
Irritability
|
62.0%
93/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
52.0%
78/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
53.3%
40/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
General disorders
Loss of appetite
|
26.7%
40/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
30.7%
46/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
30.7%
23/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
General disorders
Vomiting
|
23.3%
35/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
21.3%
32/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
12.0%
9/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.7%
19/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
14.0%
21/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
8.0%
6/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Rhinitis
|
8.7%
13/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
10.7%
16/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
8.0%
6/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Bronchitis
|
4.7%
7/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
4.7%
7/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
5.3%
4/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
|
Infections and infestations
Diarrhea infectious
|
3.3%
5/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
6.0%
9/150 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
2.7%
2/75 • Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
|
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