Trial Outcomes & Findings for V260 Registration Study (V260-013)(COMPLETED) (NCT NCT00166517)
NCT ID: NCT00166517
Last Updated: 2015-04-01
Results Overview
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
178 participants
Primary outcome timeframe
Baseline and 14 days Postdose 3
Results posted on
2015-04-01
Participant Flow
The study was conducted at 8 sites.in Korea from 02-Aug-2005 (first patient in) to 25-May-2006 (last dose given). Last subject completed follow-up: 05-Jul-2006. All data corrections applied (Frozen File) on 18- Aug-2006
Subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease; ongoing chronic diarrhea or failure to thrive and those with clinical evidence of active gastrointestinal illness were excluded.
Participant milestones
| Measure |
RotaTeq™
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
63
|
|
Overall Study
Vaccinated at Visit 1
|
115
|
63
|
|
Overall Study
Vaccinated at Visit 2
|
112
|
61
|
|
Overall Study
Vaccinated at Visit 3
|
110
|
61
|
|
Overall Study
COMPLETED
|
110
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
RotaTeq™
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
V260 Registration Study (V260-013)(COMPLETED)
Baseline characteristics by cohort
| Measure |
RotaTeq™
n=115 Participants
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
n=63 Participants
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6-12 Weeks of Age
|
114 participants
n=39 Participants
|
63 participants
n=41 Participants
|
177 participants
n=35 Participants
|
|
Age, Customized
Over 12 Weeks of Age
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
76 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 14 days Postdose 3Population: Per Protocol Population
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
Outcome measures
| Measure |
RotaTeq™
n=94 Participants
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
n=52 Participants
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Serum Anti-Rotavirus IgA Response
|
89 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and 14 days Postdose 3Population: Per Protocol Population
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3
Outcome measures
| Measure |
RotaTeq™
n=94 Participants
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
n=52 Participants
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise in SNA to G1
|
67 Participants
|
2 Participants
|
|
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise in SNA to G2
|
34 Participants
|
1 Participants
|
|
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise in SNA to G3
|
42 Participants
|
1 Participants
|
|
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise in SNA to G4
|
62 Participants
|
4 Participants
|
|
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥3-fold rise in SNA to P1A
|
65 Participants
|
3 Participants
|
Adverse Events
RotaTeq™
Serious events: 6 serious events
Other events: 110 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RotaTeq™
n=114 participants at risk
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
n=63 participants at risk
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Acute bronchiolitis
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Bronchiolitis
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Bronchitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Gastroenteritis
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Otitis media acute
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
2/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Other adverse events
| Measure |
RotaTeq™
n=114 participants at risk
Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
Placebo
n=63 participants at risk
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute tonsillopharyngitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Blood and lymphatic system disorders
Acute tonsillopharyngitis mild
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Eye disorders
Conjunctival injection
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Eye disorders
Conjunctivitis
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
2/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Eye disorders
Eye discharge
|
5.3%
6/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Eye disorders
Eye disorders
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Eye disorders
Strabismus
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Constipation
|
4.4%
5/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
6.3%
4/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.8%
59/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
54.0%
34/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Loose stools
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
4.8%
3/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Vomiting
|
57.0%
65/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
52.4%
33/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Fever
|
21.9%
25/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
27.0%
17/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Irritability
|
85.1%
97/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
82.5%
52/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Immune system disorders
Atopy
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
2/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Acute bronchiolitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Acute pharyngitis
|
3.5%
4/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
7.9%
5/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Bronchiolitis
|
11.4%
13/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
7.9%
5/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Bronchitis
|
10.5%
12/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
4.8%
3/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Chickenpox
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Cold
|
8.8%
10/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
6.3%
4/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Croup
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Enteritis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Enterovirus infection
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Folliculitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Gastroenteritis
|
11.4%
13/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
6.3%
4/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Impetigo
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Oral candidiasis
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Otitis media
|
3.5%
4/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Otitis media acute
|
3.5%
4/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Perianal abscess
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Pneumonia
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Rhinitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Skin infection
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Upper respiratory tract infection
|
38.6%
44/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
57.1%
36/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Urinary tract infection
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Fear
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Food aversion
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Renal and urinary disorders
Dysuria
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
4/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
4.8%
3/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal stuffiness
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
3/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
2/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.9%
9/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
9.5%
6/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Diaper rash
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.2%
2/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.6%
1/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.8%
2/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Vesicle
|
0.88%
1/114 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/63 • Patients in this study were followed for all adverse experiences, for 42 days following each study vaccination.
The number of patients listed in the Adverse Event tables (RotaTeq™ and Placebo) is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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