Trial Outcomes & Findings for Consistency Lots Vaccine Study (V260-009) (NCT NCT00092456)
NCT ID: NCT00092456
Last Updated: 2015-10-05
Results Overview
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
793 participants
Primary outcome timeframe
42 days following the 3rd vaccination
Results posted on
2015-10-05
Participant Flow
The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004 (last dose given). Last subject completed follow-up: 13-Aug-2004. All data corrections applied (Frozen File) date: 30-Sep-2004
Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded from the trial.
Participant milestones
| Measure |
RotaTeq™ Lot 1
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
Three oral doses (\~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
Three oral doses (\~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
226
|
225
|
229
|
113
|
|
Overall Study
Vaccinated at Visit 1
|
226
|
225
|
229
|
113
|
|
Overall Study
Vaccinated at Visit 2
|
208
|
217
|
210
|
104
|
|
Overall Study
Vaccinated at Visit 3
|
202
|
210
|
200
|
98
|
|
Overall Study
COMPLETED
|
201
|
208
|
200
|
97
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
29
|
16
|
Reasons for withdrawal
| Measure |
RotaTeq™ Lot 1
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
Three oral doses (\~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
Three oral doses (\~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
2
|
|
Overall Study
Protocol Violation
|
5
|
7
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
5
|
16
|
6
|
|
Overall Study
Moved
|
1
|
1
|
0
|
1
|
|
Overall Study
Other
|
4
|
2
|
3
|
0
|
Baseline Characteristics
Consistency Lots Vaccine Study (V260-009)
Baseline characteristics by cohort
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=225 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=113 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Total
n=793 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
6 to 12 Weeks
|
225 participants
n=5 Participants
|
224 participants
n=7 Participants
|
228 participants
n=5 Participants
|
113 participants
n=4 Participants
|
790 participants
n=21 Participants
|
|
Age, Customized
Over 12 Weeks
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
367 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
426 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
139 participants
n=5 Participants
|
144 participants
n=7 Participants
|
147 participants
n=5 Participants
|
68 participants
n=4 Participants
|
498 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
57 participants
n=5 Participants
|
49 participants
n=7 Participants
|
52 participants
n=5 Participants
|
28 participants
n=4 Participants
|
186 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
35 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
6 participants
n=4 Participants
|
42 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 42 days following the 3rd vaccinationPopulation: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=225 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=113 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
G1 SNA (dilution units)
|
167.9 dilution units
Interval 135.7 to 207.7
|
193.2 dilution units
Interval 157.6 to 236.8
|
171.0 dilution units
Interval 140.6 to 208.1
|
9.3 dilution units
Interval 7.2 to 11.9
|
|
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
G2 SNA (dilution units)
|
20.7 dilution units
Interval 17.3 to 24.7
|
22.6 dilution units
Interval 19.1 to 26.8
|
17.8 dilution units
Interval 15.1 to 20.9
|
5.9 dilution units
Interval 5.3 to 6.6
|
|
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
G3 SNA (dilution units)
|
18.0 dilution units
Interval 15.2 to 21.2
|
18.5 dilution units
Interval 15.7 to 21.9
|
14.6 dilution units
Interval 12.4 to 17.2
|
9.6 dilution units
Interval 7.4 to 12.5
|
|
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
G4 SNA (dilution units)
|
66.0 dilution units
Interval 57.0 to 76.4
|
74.3 dilution units
Interval 64.4 to 85.7
|
65.7 dilution units
Interval 55.6 to 77.5
|
7.8 dilution units
Interval 6.5 to 9.4
|
|
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
P1A[8] SNA (dilution units)
|
71.1 dilution units
Interval 60.0 to 84.2
|
72.3 dilution units
Interval 61.4 to 85.3
|
65.6 dilution units
Interval 55.0 to 78.2
|
10.2 dilution units
Interval 7.6 to 13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 42 days following the 3rd vaccinationPopulation: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.
Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=225 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=113 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).
|
292.7 units/mL
Interval 241.0 to 355.5
|
272.5 units/mL
Interval 227.9 to 325.7
|
266.2 units/mL
Interval 220.1 to 321.8
|
0.4 units/mL
Interval 0.2 to 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: Safety Population: All subjects who were vaccinated and followed up
Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects With Clinical Adverse Experiences (CAEs)
With CAEs
|
207 Participants
|
213 Participants
|
212 Participants
|
101 Participants
|
|
Number of Subjects With Clinical Adverse Experiences (CAEs)
Without CAEs
|
19 Participants
|
11 Participants
|
17 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)
With Serious CAEs
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)
Without Serious CAEs
|
222 Participants
|
220 Participants
|
227 Participants
|
108 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects With Vaccine-Related Clinical AEs (CAEs)
With vaccine-related CAEs
|
167 Participants
|
173 Participants
|
165 Participants
|
78 Participants
|
|
Number of Subjects With Vaccine-Related Clinical AEs (CAEs)
Without vaccine-related CAEs
|
59 Participants
|
51 Participants
|
64 Participants
|
33 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)
With serious vaccine-related CAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)
Without serious vaccine-related CAEs
|
226 Participants
|
224 Participants
|
229 Participants
|
110 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects Discontinued Due to Clinical Adverse Experiences
Discontinued due to CAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Discontinued Due to Clinical Adverse Experiences
Not discontinued due to CAEs
|
226 Participants
|
224 Participants
|
228 Participants
|
110 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
Discontinued due to vaccine-related CAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
Not discontinued due to vaccine-related CAEs
|
226 Participants
|
224 Participants
|
229 Participants
|
110 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
Discontinued due to serious CAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
Not discontinued due to serious CAEs
|
226 Participants
|
224 Participants
|
228 Participants
|
110 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred firstPopulation: All subjects who were vaccinated and followed up
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Outcome measures
| Measure |
RotaTeq™ Lot 1
n=226 Participants
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 Participants
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 Participants
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 Participants
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
Discontinued due to serious vaccine-related CAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
NOTdiscontinued dueto serious vaccine-related CAEs
|
226 Participants
|
224 Participants
|
229 Participants
|
110 Participants
|
Adverse Events
RotaTeq™ Lot 1
Serious events: 4 serious events
Other events: 206 other events
Deaths: 0 deaths
RotaTeq™ Lot 2
Serious events: 4 serious events
Other events: 212 other events
Deaths: 0 deaths
RotaTeq™ Lot 3
Serious events: 2 serious events
Other events: 211 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RotaTeq™ Lot 1
n=226 participants at risk
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 participants at risk
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 participants at risk
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 participants at risk
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital ventricular septal defect
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Influenza
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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 viral
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Sepsis
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Urosepsis
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Dehydration
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Respiratory distress
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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™ Lot 1
n=226 participants at risk
Three oral doses (\~8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 2
n=224 participants at risk
Three oral doses ( \~8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
RotaTeq™ Lot 3
n=229 participants at risk
Three oral doses ( \~6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
Placebo
n=111 participants at risk
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.88%
2/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
4/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
6.2%
14/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
4.5%
10/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.9%
9/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
7/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Dacryostenosis acquired
|
0.88%
2/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.5%
8/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Abdominal pain upper
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
6.6%
15/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
8/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
6.6%
15/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
7/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
48.7%
110/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
54.5%
122/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
45.0%
103/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
45.0%
50/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Flatulence
|
4.4%
10/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
7.1%
16/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
11/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
4.5%
5/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
6/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.5%
8/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Infantile colic
|
2.2%
5/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Infrequent bowel movements
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Regurgitation of food
|
2.2%
5/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Teething
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
4/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
32.7%
74/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
37.9%
85/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
33.6%
77/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
30.6%
34/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Injection site discomfort
|
2.7%
6/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
8/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.6%
6/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
5.4%
6/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Injection site pain
|
6.2%
14/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
12.1%
27/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
8.7%
20/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
7/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Pyrexia
|
52.7%
119/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
54.5%
122/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
50.2%
115/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
46.8%
52/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Hypersensitivity
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
7.1%
16/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
6.2%
14/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
9.2%
21/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
7/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Candida nappy rash
|
2.2%
5/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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 infectious
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
6/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.7%
4/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Ear infection
|
0.88%
2/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
6/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.7%
4/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Eye infection
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
4.9%
11/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.1%
7/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.1%
7/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Herpangina
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Influenza
|
0.88%
2/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Nasopharyngitis
|
17.7%
40/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
22.3%
50/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
14.8%
34/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
19.8%
22/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
4.4%
10/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
8/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.1%
7/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
5.4%
6/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
20.4%
46/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
23.7%
53/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
22.3%
51/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
18.0%
20/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Respiratory syncytial virus infection
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.88%
2/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.6%
6/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
32.3%
73/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
31.7%
71/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
30.1%
69/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
32.4%
36/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Viral infection
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
5.8%
13/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.6%
6/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
4/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Viral rash
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.7%
4/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Viral upper respiratory tract infection
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
3.5%
8/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.87%
2/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Dehydration
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Pain in extremity
|
3.5%
8/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
4.0%
9/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
5.2%
12/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Agitation
|
1.8%
4/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Crying
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.7%
4/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Insomnia
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Irritability
|
13.7%
31/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
21.9%
49/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
21.4%
49/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
16.2%
18/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Sleep disorder
|
0.44%
1/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Bronchospasm
|
3.1%
7/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.1%
7/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.5%
8/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
4/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
12.4%
28/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
10.3%
23/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
12.7%
29/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
11.7%
13/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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 congestion
|
11.9%
27/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
8.9%
20/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
9.6%
22/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
9.9%
11/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Respiratory tract congestion
|
3.1%
7/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
9.7%
22/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
4.0%
9/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
11/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
4.5%
5/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Wheezing
|
3.5%
8/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.89%
2/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.7%
4/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.90%
1/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
2.2%
5/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
6/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.8%
2/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Eczema
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
6/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.6%
4/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Rash
|
2.2%
5/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.2%
5/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
3.5%
8/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
2.7%
3/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
Seborrhoeic dermatitis
|
0.00%
0/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
1.3%
3/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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
|
1.3%
3/226 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.45%
1/224 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
|
0.44%
1/229 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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%
0/111 • Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - 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.
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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