Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine (NCT NCT03554798)
NCT ID: NCT03554798
Last Updated: 2024-01-19
Results Overview
Number of subjects experiencing Serious Adverse Reactions (SAR), severe AR and IMR, i.e. SAEs, severe AEs (grade 3), or IMEs considered consistent with a causal association with study vaccines as of the informed consent signature date and throughout the study period in all groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1025 participants
Primary outcome timeframe
6 months
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
Stage I - Group A2H2
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
|
Stage II - Group B1H1+H2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1+L2 [2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
51
|
156
|
144
|
138
|
150
|
135
|
151
|
|
Overall Study
COMPLETED
|
45
|
47
|
48
|
154
|
141
|
137
|
149
|
133
|
149
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
3
|
2
|
3
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine
Baseline characteristics by cohort
| Measure |
Stage I - Group A2H2
n=50 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=49 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=156 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=144 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=138 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=150 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=135 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=151 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Total
n=1024 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
138 Participants
n=10 Participants
|
150 Participants
n=115 Participants
|
135 Participants
n=6 Participants
|
151 Participants
n=6 Participants
|
1024 Participants
n=64 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
71 Participants
n=115 Participants
|
74 Participants
n=6 Participants
|
73 Participants
n=6 Participants
|
488 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
79 Participants
n=115 Participants
|
61 Participants
n=6 Participants
|
78 Participants
n=6 Participants
|
536 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
24 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
147 Participants
n=115 Participants
|
132 Participants
n=6 Participants
|
151 Participants
n=6 Participants
|
981 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Other
|
26 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
26 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Central American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Region of Enrollment
Panama
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
51 participants
n=5 Participants
|
156 participants
n=4 Participants
|
144 participants
n=21 Participants
|
138 participants
n=10 Participants
|
150 participants
n=115 Participants
|
135 participants
n=6 Participants
|
151 participants
n=6 Participants
|
1024 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Safety parameters were tabulated and analyzed descriptively in the total vaccinated (TV) population, according to the actual vaccine received. TV population is defined as all subjects who received at least one dose of study vaccine.
Number of subjects experiencing Serious Adverse Reactions (SAR), severe AR and IMR, i.e. SAEs, severe AEs (grade 3), or IMEs considered consistent with a causal association with study vaccines as of the informed consent signature date and throughout the study period in all groups.
Outcome measures
| Measure |
Stage I - Group A2H2
n=50 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=49 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=155 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=144 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=138 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=150 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=135 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=151 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence
|
0 participants
|
1 participants
|
0 participants
|
5 participants
|
6 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Per Protocol Population
Seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following a single 105 or 106 CCID50 dose of nOPV2 candidates in all groups. Seroprotection rate is defined as the percentage of subjects with type 2-specific antibody titers ≥ 1:8 per group.
Outcome measures
| Measure |
Stage I - Group A2H2
n=45 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=37 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=47 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=145 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=136 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=131 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=143 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=127 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=146 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Single Dose Seroprotection Rate
|
45 Participants
|
37 Participants
|
47 Participants
|
125 Participants
|
132 Participants
|
122 Participants
|
134 Participants
|
115 Participants
|
138 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Assessed in total vaccinated (TV) population, defined as all subjects who received at least one dose of study vaccine.Only secondary objectives included intent to compare the M5 data with the control sample which had received Sabin mOPV2 in M2 study (NCT02521974-historical control for M5). Extent of exposure: in M5 Stage II, the second dose of study vaccine were received by 47 (94%) children in Group A1H2\[2018\] and 50 (98%) children in Group A2H2\[2018\].
Number of participants experiencing any other SAE, any solicited AE, any unsolicited AEs and any IME as well as any clinical laboratory deviation considered consistent with causal association to study vaccine (primary objective) following one or two doses of either nOPV2 candidates.
Outcome measures
| Measure |
Stage I - Group A2H2
n=50 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=49 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=155 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=144 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=138 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=150 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=135 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=151 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
n=110 Participants
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
n=50 Participants
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Any Other SAEs, AEs and IMEs Incidence
SAEs
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
9 participants
|
1 participants
|
3 participants
|
5 participants
|
0 participants
|
1 participants
|
|
Any Other SAEs, AEs and IMEs Incidence
AEs
|
32 participants
|
36 participants
|
44 participants
|
30 participants
|
29 participants
|
34 participants
|
37 participants
|
36 participants
|
33 participants
|
36 participants
|
28 participants
|
|
Any Other SAEs, AEs and IMEs Incidence
IMEs
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974.
Seroconversion rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroconversion is defined as a change from seronegative to seropositive, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline (Day 0) titers corrected for maternal antibodies titers where applicable/age-appropriate.
Outcome measures
| Measure |
Stage I - Group A2H2
n=19 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=17 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=23 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=42 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=45 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=45 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=48 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=44 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=48 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
n=39 Participants
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
n=9 Participants
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Rates Comparison
|
18 Participants
|
17 Participants
|
22 Participants
|
40 Participants
|
43 Participants
|
44 Participants
|
47 Participants
|
38 Participants
|
48 Participants
|
38 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Subset of subjects with baseline immunity (NAb titer) sufficiently low to enable observation of seroconversion (≤8.5 log2 i.e. ≤4-fold from assay ULOQ) at D56. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974.
Seroprotection rates against type 2 of one or two 106 CCID50 doses of both nOPV2 vaccine candidates in healthy children aged 1 to 5 years and of two doses of both nOPV2 vaccine candidates at both 105 and 106 CCID50 dose levels at approximately 22 weeks of age in infants previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this immunogenicity with a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study (M2) designed and performed to serve as a control for the current study. Seroprotection rate is defined as the percentage of subjects with type 2-specific neutralizing antibody titers ≥ 1:8 per group.
Outcome measures
| Measure |
Stage I - Group A2H2
n=44 Participants
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=39 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=46 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=44 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=47 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=46 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=48 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=44 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=48 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
n=40 Participants
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
n=46 Participants
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroprotection Rates Comparison
|
44 Participants
|
39 Participants
|
46 Participants
|
44 Participants
|
46 Participants
|
45 Participants
|
48 Participants
|
43 Participants
|
48 Participants
|
39 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Subset of subjects corresponding to 2018 Candidates cohorts. 2016 Candidate cohorts did not participate on this endpoint assessment. Only secondary objectives included intent to compare the M5 data with the control sample of similarly aged infants and young children who had received Sabin mOPV2 in a M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974.
Level of viral shedding in stool at fixed time points following administration of one or two doses of both nOPV2 candidates at both 105 and 106 CCID50 dose levels in infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and compare this shedding to a control sample of participants receiving the same vaccination schedule followed by one or two doses of Sabin mOPV2 in a prior study designed to serve as a control for the current study. This is determined by measuring the median number of days taken to get stool cultures negative for poliovirus presence (TTCN stands for median time to culture negative). Kaplan-Meier methods were used to describe the time to cessation of shedding for any shedding (PCR detection).
Outcome measures
| Measure |
Stage I - Group A2H2
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=46 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 Participants
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=125 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
n=140 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
n=124 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=141 Participants
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
n=91 Participants
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
n=48 Participants
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Viral Shedding
|
—
|
5 days
Interval 4.0 to 5.0
|
3 days
Interval 2.5 to 5.0
|
—
|
—
|
6 days
Interval 5.0 to 7.0
|
6 days
Interval 5.0 to 7.0
|
6 days
Interval 5.0 to 7.0
|
5 days
Interval 4.0 to 6.0
|
6 days
Interval 5.0 to 7.0
|
6.5 days
Interval 5.0 to 9.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Per the description under the Outcome Measure Description section, these groups do not match the participants arms distribution, as these results are related to the vaccine candidates behaviour in mice, not to the participating subjects. Only secondary objectives included intent to compare the M5 data with the control sample of M2 study, which was designed to serve as a historical control for M5. For further details on results corresponding to M2 study, please refer to NCT02521974.
Potential for neurovirulence of virus isolated from a subset of stool samples of infants at approximately 18-22 weeks of age after having been previously vaccinated with 3 doses of bOPV and 1 dose of IPV, and following a single dose of both nOPV2 candidates at the 106 CCID50 dose level, as measured in an animal model, and compare this with a control sample (M2 study). For each of the children / infants receiving a 106 CCID50 dose of the 2018 cohorts as well as all participants in study M2, an exploratory endpoint sample (EES) of poliovirus shed in stools following the first dose was identified, if possible, with which to perform a modified neurovirulence test in a transgenic mouse model. Data from each sample tested was summarized by group per vaccine candidate. The proportion of mice paralyzed and the odds ratio of paralysis from the single-dose assay were the primary means of comparison of neurovirulence of shed virus between each candidate and the Sabin mOPV2 control samples.
Outcome measures
| Measure |
Stage I - Group A2H2
n=5 EES
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=22 EES
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=29 EES
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2L1\[2016\] to receive a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).50 infants randomly selected to receive a second 105 CCID50 dose of candidate 1 (2018), 28 days later
|
Stage II - Group B1H1+H2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1 +L2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
M2 Group 2+3
114 infants (3 bOPV/1 IPV primed) were to receive at 18 weeks of age one dose of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 2). A randomly selected sub-group of 50 infants were to receive a second dose of Sabin mOPV2 approximately 28 days later (Group 3).
|
M2 Children
50 IPV and/or OPV vaccinated children aged 1 to \<5 years were to receive 2 doses of Sabin mOPV2 (at a titer of ≥ 105 CCID50) (Group 1), separated by 28 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neurovirulence
|
90 percentage of neurovirulence
|
0 percentage of neurovirulence
|
30 percentage of neurovirulence
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Stage I - Group A2H2
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Stage II - A1H2 [2018]
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Stage II - A2H2 [2018]
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Stage I -- Group B2L1+L2[2016]
Serious events: 7 serious events
Other events: 82 other events
Deaths: 0 deaths
Stage I - B2H1+H2[2016]
Serious events: 1 serious events
Other events: 93 other events
Deaths: 0 deaths
Stage II - Group B1L1+L2[2018]
Serious events: 14 serious events
Other events: 129 other events
Deaths: 0 deaths
Stage II - Group B1H1+H2[2018]
Serious events: 14 serious events
Other events: 127 other events
Deaths: 0 deaths
Stage II - Group B2L1+L2 [2018]
Serious events: 9 serious events
Other events: 118 other events
Deaths: 0 deaths
Stage II - Group B2H1+H2[2018]
Serious events: 15 serious events
Other events: 126 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Stage I - Group A2H2
n=50 participants at risk
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=49 participants at risk
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 participants at risk
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=155 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=144 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=138 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
|
Stage II - Group B1H1+H2[2018]
n=150 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1+L2 [2018]
n=135 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=151 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.00%
0/50 • 6 months
|
2.0%
1/49 • 6 months
|
2.0%
1/51 • 6 months
|
1.3%
2/155 • 6 months
|
0.00%
0/144 • 6 months
|
6.5%
9/138 • 6 months
|
5.3%
8/150 • 6 months
|
1.5%
2/135 • 6 months
|
6.6%
10/151 • 6 months
|
|
Ear and labyrinth disorders
Soft Tissue Abscess (preauricular)
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
2.0%
1/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
General disorders
Urticaria
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
2.0%
1/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
2.6%
4/155 • 6 months
|
0.69%
1/144 • 6 months
|
2.9%
4/138 • Number of events 7 • 6 months
|
4.0%
6/150 • 6 months
|
3.0%
4/135 • 6 months
|
2.0%
3/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Second degree burn
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Nervous system disorders
Tonic clonic seizure
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • Number of events 2 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Acute Diarrheal Disease
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Cardiac disorders
Ventricular Septal Defect
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Withlow left hand
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Congenital, familial and genetic disorders
Congeniital Cortical Blindness
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
Other adverse events
| Measure |
Stage I - Group A2H2
n=50 participants at risk
50 polio vaccine primed children aged 1 to \<5 years were to receive two 106 CCID50 doses of nOPV2 candidate 2, 2016, separated by 28 days (Group A2H2\[2016\]).
|
Stage II - A1H2 [2018]
n=49 participants at risk
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 1 (2018) separated by 28 days.
|
Stage II - A2H2 [2018]
n=51 participants at risk
50 IPV and/or OPV vaccinated participants aged 1 to 5 years administered with two 106 CCID50 doses of candidate 2 (2018) separated by 28 days.
|
Stage I -- Group B2L1+L2[2016]
n=155 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 (2016). 50 randomly selected subjects from group B2L1 received a second 105 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage I - B2H1+H2[2016]
n=144 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 (2016).50 infants randomly selected from B2H1\[2016\] to receive a second 106 CCID50 dose of candidate 2 (2016), 28 days later.
|
Stage II - Group B1L1+L2[2018]
n=138 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) administered with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 1 (2018).
|
Stage II - Group B1H1+H2[2018]
n=150 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 1.50 infants randomly selected to receive a second 106 CCID50 dose of candidate 1, 28 days later
|
Stage II - Group B2L1+L2 [2018]
n=135 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 105 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 105 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
Stage II - Group B2H1+H2[2018]
n=151 participants at risk
162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 106 CCID50 dose of candidate 2 \[2018\].50 infants randomly selected to receive a second 106 CCID50 dose of candidate 2 \[2018\], 28 days later.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
18.0%
9/50 • 6 months
|
46.9%
23/49 • 6 months
|
49.0%
25/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
General disorders
Irritability
|
4.0%
2/50 • 6 months
|
6.1%
3/49 • 6 months
|
9.8%
5/51 • 6 months
|
19.4%
30/155 • 6 months
|
12.5%
18/144 • 6 months
|
16.7%
23/138 • 6 months
|
18.0%
27/150 • 6 months
|
18.5%
25/135 • 6 months
|
16.6%
25/151 • 6 months
|
|
General disorders
Abnormal crying
|
4.0%
2/50 • 6 months
|
14.3%
7/49 • 6 months
|
9.8%
5/51 • 6 months
|
22.6%
35/155 • 6 months
|
16.7%
24/144 • 6 months
|
18.8%
26/138 • 6 months
|
16.0%
24/150 • 6 months
|
15.6%
21/135 • 6 months
|
16.6%
25/151 • 6 months
|
|
General disorders
Fever
|
12.0%
6/50 • 6 months
|
24.5%
12/49 • 6 months
|
29.4%
15/51 • 6 months
|
9.0%
14/155 • 6 months
|
8.3%
12/144 • 6 months
|
10.9%
15/138 • 6 months
|
8.0%
12/150 • 6 months
|
14.8%
20/135 • 6 months
|
11.9%
18/151 • 6 months
|
|
General disorders
Loss of Appetite
|
32.0%
16/50 • 6 months
|
26.5%
13/49 • 6 months
|
25.5%
13/51 • 6 months
|
14.2%
22/155 • 6 months
|
9.0%
13/144 • 6 months
|
8.0%
11/138 • 6 months
|
10.0%
15/150 • 6 months
|
10.4%
14/135 • 6 months
|
12.6%
19/151 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • 6 months
|
10.2%
5/49 • 6 months
|
11.8%
6/51 • 6 months
|
12.9%
20/155 • 6 months
|
14.6%
21/144 • 6 months
|
13.8%
19/138 • 6 months
|
14.7%
22/150 • 6 months
|
14.8%
20/135 • 6 months
|
12.6%
19/151 • 6 months
|
|
General disorders
Drowsiness
|
4.0%
2/50 • 6 months
|
18.4%
9/49 • 6 months
|
9.8%
5/51 • 6 months
|
5.2%
8/155 • 6 months
|
6.2%
9/144 • 6 months
|
4.3%
6/138 • 6 months
|
7.3%
11/150 • 6 months
|
7.4%
10/135 • 6 months
|
9.9%
15/151 • 6 months
|
|
Infections and infestations
Pharyngotonsillitis
|
8.0%
4/50 • 6 months
|
14.3%
7/49 • 6 months
|
15.7%
8/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
22.0%
11/50 • 6 months
|
18.4%
9/49 • 6 months
|
7.8%
4/51 • 6 months
|
5.8%
9/155 • 6 months
|
4.9%
7/144 • 6 months
|
1.4%
2/138 • 6 months
|
6.0%
9/150 • 6 months
|
0.74%
1/135 • 6 months
|
2.6%
4/151 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
36.0%
18/50 • 6 months
|
4.1%
2/49 • 6 months
|
7.8%
4/51 • 6 months
|
33.5%
52/155 • 6 months
|
45.1%
65/144 • 6 months
|
44.9%
62/138 • 6 months
|
47.3%
71/150 • 6 months
|
51.1%
69/135 • 6 months
|
51.7%
78/151 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
4.0%
2/50 • 6 months
|
12.2%
6/49 • 6 months
|
11.8%
6/51 • 6 months
|
0.65%
1/155 • 6 months
|
1.4%
2/144 • 6 months
|
2.9%
4/138 • 6 months
|
1.3%
2/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Rhinitis
|
10.0%
5/50 • 6 months
|
10.2%
5/49 • 6 months
|
9.8%
5/51 • 6 months
|
7.1%
11/155 • 6 months
|
5.6%
8/144 • 6 months
|
3.6%
5/138 • 6 months
|
2.0%
3/150 • 6 months
|
5.2%
7/135 • 6 months
|
3.3%
5/151 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • 6 months
|
2.0%
1/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
1.4%
2/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Otitis
|
0.00%
0/50 • 6 months
|
6.1%
3/49 • 6 months
|
7.8%
4/51 • 6 months
|
0.00%
0/155 • 6 months
|
2.1%
3/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/50 • 6 months
|
2.0%
1/49 • 6 months
|
11.8%
6/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • 6 months
|
0.00%
0/49 • 6 months
|
2.0%
1/51 • 6 months
|
2.6%
4/155 • 6 months
|
4.2%
6/144 • 6 months
|
2.2%
3/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.74%
1/135 • 6 months
|
4.0%
6/151 • 6 months
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • 6 months
|
4.1%
2/49 • 6 months
|
3.9%
2/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Varicella
|
0.00%
0/50 • 6 months
|
2.0%
1/49 • 6 months
|
3.9%
2/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
2.0%
1/50 • 6 months
|
4.1%
2/49 • 6 months
|
5.9%
3/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/50 • 6 months
|
6.1%
3/49 • 6 months
|
5.9%
3/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/50 • 6 months
|
6.1%
3/49 • 6 months
|
2.0%
1/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/50 • 6 months
|
6.1%
3/49 • 6 months
|
3.9%
2/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Gastrointestinal disorders
Teething
|
2.0%
1/50 • 6 months
|
10.2%
5/49 • 6 months
|
3.9%
2/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.72%
1/138 • 6 months
|
4.7%
7/150 • 6 months
|
0.74%
1/135 • 6 months
|
6.0%
9/151 • 6 months
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
2.1%
3/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
2.2%
3/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
2.6%
4/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.00%
0/135 • 6 months
|
1.3%
2/151 • 6 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
2.0%
3/150 • 6 months
|
0.00%
0/135 • 6 months
|
1.3%
2/151 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.3%
2/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
2.9%
4/138 • 6 months
|
4.7%
7/150 • 6 months
|
2.2%
3/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
0.00%
0/144 • 6 months
|
1.4%
2/138 • 6 months
|
2.7%
4/150 • 6 months
|
0.74%
1/135 • 6 months
|
2.6%
4/151 • 6 months
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Impetigo
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
0.00%
0/144 • 6 months
|
1.4%
2/138 • 6 months
|
0.67%
1/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Viral Conjunctivitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Viral Gastroenteritis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Viral Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.74%
1/135 • 6 months
|
1.3%
2/151 • 6 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Eye Infection Bacterial
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Pyoderma
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
2.0%
3/150 • 6 months
|
0.00%
0/135 • 6 months
|
1.3%
2/151 • 6 months
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
5.8%
9/155 • 6 months
|
2.1%
3/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
3.3%
5/151 • 6 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
2.1%
3/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Herpangina
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
2.9%
4/138 • 6 months
|
3.3%
5/150 • 6 months
|
3.7%
5/135 • 6 months
|
4.0%
6/151 • 6 months
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
1.3%
2/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
3.2%
5/155 • 6 months
|
1.4%
2/144 • 6 months
|
4.3%
6/138 • 6 months
|
6.7%
10/150 • 6 months
|
3.7%
5/135 • 6 months
|
3.3%
5/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.72%
1/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.00%
0/135 • 6 months
|
2.6%
4/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
2.0%
3/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
2.7%
4/150 • 6 months
|
3.7%
5/135 • 6 months
|
3.3%
5/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
2.1%
3/144 • 6 months
|
0.72%
1/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
5.3%
8/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Infantile Colic
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
1.4%
2/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.3%
2/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.9%
3/155 • 6 months
|
1.4%
2/144 • 6 months
|
1.4%
2/138 • 6 months
|
2.0%
3/150 • 6 months
|
5.2%
7/135 • 6 months
|
2.6%
4/151 • 6 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.67%
1/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
1.4%
2/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Immune system disorders
Milk Allergy
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
1.3%
2/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Investigations
Transaminases increase
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Nervous system disorders
Gross Motor Delay
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.65%
1/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Psychiatric disorders
Neurodevelopmental Disorder
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Ear and labyrinth disorders
External Ear Inflammation
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.69%
1/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Body Tinea
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
1.4%
2/138 • 6 months
|
1.3%
2/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Abscess
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Abscess Jaw
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Amoebic Dysentery
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Ear Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Roseola
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Spinal Cord Abscess
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Tinea Versicolour
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.67%
1/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Strabismus
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
1.5%
2/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Psychiatric disorders
Psychomotor Retardation
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Nervous system disorders
Motor Developmental Delay
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.72%
1/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Immune system disorders
Food Allergy
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Eye disorders
Blindness Cortical
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
|
Infections and infestations
Infected Bite Infection
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.74%
1/135 • 6 months
|
0.00%
0/151 • 6 months
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/50 • 6 months
|
0.00%
0/49 • 6 months
|
0.00%
0/51 • 6 months
|
0.00%
0/155 • 6 months
|
0.00%
0/144 • 6 months
|
0.00%
0/138 • 6 months
|
0.00%
0/150 • 6 months
|
0.00%
0/135 • 6 months
|
0.66%
1/151 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place