Trial Outcomes & Findings for IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults (NCT NCT03092791)
NCT ID: NCT03092791
Last Updated: 2020-01-31
Results Overview
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
340 participants
Primary outcome timeframe
Within 7 days of the First Dose given on Day 1
Results posted on
2020-01-31
Participant Flow
Participants took part in the study at four investigative sites in Panama from 7 June 2017 to 18 October 2018.
Healthy participants were randomized to one of two (adult and toddler lead-ins) or four (infant dose ranging) arms in a 1:1 or a 1:1:1:1 ratio, to receive sIPV or reference sIPV. Two groups received placebo.
Participant milestones
| Measure |
Adult Lead-in Cohort: sIPV High Dose
Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Adult Lead-in Cohort: Placebo
Placebo, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: sIPV High Dose
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: Reference IPV
Reference IPV, intramuscular injection on Day 1.
|
Infant Dose Ranging Cohort: sIPV Low Dose
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
30
|
30
|
60
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
20
|
20
|
30
|
30
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
60
|
60
|
60
|
60
|
Reasons for withdrawal
| Measure |
Adult Lead-in Cohort: sIPV High Dose
Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Adult Lead-in Cohort: Placebo
Placebo, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: sIPV High Dose
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: Reference IPV
Reference IPV, intramuscular injection on Day 1.
|
Infant Dose Ranging Cohort: sIPV Low Dose
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of Consent
|
0
|
0
|
0
|
0
|
4
|
12
|
6
|
4
|
|
Overall Study
Study Termination
|
0
|
0
|
0
|
0
|
55
|
46
|
53
|
55
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Data for age in adults is reported.
Baseline characteristics by cohort
| Measure |
Adult Lead-in Cohort: sIPV High Dose
n=20 Participants
Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Adult Lead-in Cohort: Placebo
n=20 Participants
Placebo, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: sIPV High Dose
n=30 Participants
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: Reference IPV
n=30 Participants
Reference IPV, intramuscular injection on Day 1.
|
Infant Dose Ranging Cohort: sIPV Low Dose
n=60 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 8.56 • n=20 Participants • Data for age in adults is reported.
|
35.1 years
STANDARD_DEVIATION 8.23 • n=20 Participants • Data for age in adults is reported.
|
14.1 months
STANDARD_DEVIATION 0.98 • n=30 Participants • Data for age in toddlers is reported.
|
14.0 months
STANDARD_DEVIATION 1.02 • n=30 Participants • Data for age in toddlers is reported.
|
6.6 weeks
STANDARD_DEVIATION 0.67 • n=60 Participants • Data for age in infants is reported.
|
6.5 weeks
STANDARD_DEVIATION 0.62 • n=60 Participants • Data for age in infants is reported.
|
6.5 weeks
STANDARD_DEVIATION 0.68 • n=60 Participants • Data for age in infants is reported.
|
6.5 weeks
STANDARD_DEVIATION 0.62 • n=60 Participants • Data for age in infants is reported.
|
6.5 weeks
STANDARD_DEVIATION 0.65 • n=240 Participants • Data for age in infants is reported.
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
13 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
31 Participants
n=60 Participants
|
33 Participants
n=60 Participants
|
29 Participants
n=60 Participants
|
22 Participants
n=60 Participants
|
169 Participants
n=340 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
17 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
29 Participants
n=60 Participants
|
27 Participants
n=60 Participants
|
31 Participants
n=60 Participants
|
38 Participants
n=60 Participants
|
171 Participants
n=340 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
29 Participants
n=30 Participants
|
29 Participants
n=30 Participants
|
58 Participants
n=60 Participants
|
57 Participants
n=60 Participants
|
55 Participants
n=60 Participants
|
58 Participants
n=60 Participants
|
317 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
16 Participants
n=340 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
6 Participants
n=340 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=340 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=340 Participants
|
|
Region of Enrollment
Panama
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
60 Participants
n=60 Participants
|
60 Participants
n=60 Participants
|
60 Participants
n=60 Participants
|
340 Participants
n=340 Participants
|
|
Height
|
160.00 centimeter (cm)
n=20 Participants
|
161.45 centimeter (cm)
n=20 Participants
|
77.13 centimeter (cm)
n=30 Participants
|
76.53 centimeter (cm)
n=30 Participants
|
55.71 centimeter (cm)
n=60 Participants
|
56.29 centimeter (cm)
n=60 Participants
|
55.21 centimeter (cm)
n=60 Participants
|
56.21 centimeter (cm)
n=60 Participants
|
87.31 centimeter (cm)
n=340 Participants
|
|
Weight
|
74.30 kilogram (kg)
n=20 Participants
|
68.74 kilogram (kg)
n=20 Participants
|
10.21 kilogram (kg)
n=30 Participants
|
10.32 kilogram (kg)
n=30 Participants
|
4.94 kilogram (kg)
n=60 Participants
|
4.94 kilogram (kg)
n=60 Participants
|
4.89 kilogram (kg)
n=60 Participants
|
4.98 kilogram (kg)
n=60 Participants
|
22.91 kilogram (kg)
n=340 Participants
|
|
Body Mass Index (BMI)
|
28.95 kg/m^2
STANDARD_DEVIATION 3.253 • n=20 Participants • Data for BMI in adults is reported.
|
26.25 kg/m^2
STANDARD_DEVIATION 4.489 • n=20 Participants • Data for BMI in adults is reported.
|
—
|
—
|
—
|
—
|
—
|
—
|
27.60 kg/m^2
STANDARD_DEVIATION 4.103 • n=40 Participants • Data for BMI in adults is reported.
|
|
Baseline Seropositivity
Sabin Type 1
|
—
|
—
|
90.0 percentage of participants seropositive
n=27 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
86.7 percentage of participants seropositive
n=26 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
50.0 percentage of participants seropositive
n=30 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
50.0 percentage of participants seropositive
n=30 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
35.0 percentage of participants seropositive
n=21 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
43.3 percentage of participants seropositive
n=26 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
59.16 percentage of participants seropositive
n=160 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
|
Baseline Seropositivity
Sabin Type 2
|
—
|
—
|
93.3 percentage of participants seropositive
n=28 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
93.3 percentage of participants seropositive
n=28 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
66.7 percentage of participants seropositive
n=40 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
68.3 percentage of participants seropositive
n=41 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
63.3 percentage of participants seropositive
n=38 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
66.7 percentage of participants seropositive
n=40 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
75.26 percentage of participants seropositive
n=215 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
|
Baseline Seropositivity
Sabin Type 3
|
—
|
—
|
93.3 percentage of participants seropositive
n=28 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
90.0 percentage of participants seropositive
n=27 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
23.3 percentage of participants seropositive
n=14 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
31.7 percentage of participants seropositive
n=19 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
30.0 percentage of participants seropositive
n=18 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
33.3 percentage of participants seropositive
n=20 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
50.26 percentage of participants seropositive
n=126 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
|
Baseline Seropositivity
Salk Type 1
|
—
|
—
|
96.7 percentage of participants seropositive
n=29 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
96.7 percentage of participants seropositive
n=29 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
33.3 percentage of participants seropositive
n=20 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
36.7 percentage of participants seropositive
n=22 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
30.0 percentage of participants seropositive
n=18 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
33.3 percentage of participants seropositive
n=20 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
54.45 percentage of participants seropositive
n=138 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
|
Baseline Seropositivity
Salk Type 2
|
—
|
—
|
96.7 percentage of participants seropositive
n=29 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
90.0 percentage of participants seropositive
n=27 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
40.0 percentage of participants seropositive
n=24 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
43.3 percentage of participants seropositive
n=26 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
41.7 percentage of participants seropositive
n=25 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
40.0 percentage of participants seropositive
n=24 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
58.61 percentage of participants seropositive
n=155 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
|
Baseline Seropositivity
Salk Type 3
|
—
|
—
|
93.3 percentage of participants seropositive
n=28 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
90.0 percentage of participants seropositive
n=27 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
21.7 percentage of participants seropositive
n=13 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
15.0 percentage of participants seropositive
n=9 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
23.3 percentage of participants seropositive
n=14 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
21.7 percentage of participants seropositive
n=13 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
44.16 percentage of participants seropositive
n=104 Participants • Randomized set included all randomized participants. Number analyzed is the number of participants with data available for analysis at the given timepoint. Data are reported for 'Toddler Lead-in Cohort and Infant Dose Ranging Cohort'.
|
PRIMARY outcome
Timeframe: Within 7 days of the First Dose given on Day 1Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Pain: First Dose (Day 1), Mild
|
26.3 percentage of participants
|
30.8 percentage of participants
|
41.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Erythema: First Dose (Day 1), Any
|
5.3 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Swelling: First Dose (Day 1), Any
|
1.8 percentage of participants
|
7.8 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Pain: First Dose (Day 1), Any
|
84.2 percentage of participants
|
69.2 percentage of participants
|
80.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Pain: First Dose (Day 1), Moderate
|
31.6 percentage of participants
|
17.3 percentage of participants
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Pain: First Dose (Day 1), Severe
|
26.3 percentage of participants
|
21.2 percentage of participants
|
14.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Induration: First Dose (Day 1), Any
|
1.8 percentage of participants
|
3.9 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Induration: First Dose (Day 1), Moderate
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Swelling: First Dose (Day 1), Moderate
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the Second Dose given on Day 29Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Pain: Second Dose (Day 29), Any
|
48.2 percentage of participants
|
47.9 percentage of participants
|
61.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Pain: Second Dose (Day 29), Moderate
|
14.3 percentage of participants
|
16.7 percentage of participants
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Pain: Second Dose (Day 29), Severe
|
3.6 percentage of participants
|
6.3 percentage of participants
|
7.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Erythema: Second Dose (Day 29), Any
|
1.8 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Induration: Second Dose (Day 29), Any
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Swelling: Second Dose (Day 29), Any
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Swelling: Second Dose (Day 29), Mild
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Pain: Second Dose (Day 29), Mild
|
30.4 percentage of participants
|
25.0 percentage of participants
|
36.4 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days of the Third Dose given on Day 57Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Swelling: Third Dose (Day 57), Any
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Pain: Third Dose (Day 57), Any
|
46.4 percentage of participants
|
44.4 percentage of participants
|
49.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Pain: Third Dose (Day 57), Mild
|
33.9 percentage of participants
|
31.1 percentage of participants
|
34.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Pain: Third Dose (Day 57), Moderate
|
8.9 percentage of participants
|
8.9 percentage of participants
|
11.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Pain: Third Dose (Day 57), Severe
|
3.6 percentage of participants
|
4.4 percentage of participants
|
3.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Erythema: Third Dose (Day 57), Any
|
0 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the First Dose given on Day 1Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Drowsiness: First Dose (Day 1), Moderate
|
8.8 percentage of participants
|
13.5 percentage of participants
|
21.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Irritability: First Dose (Day 1), Mild
|
28.1 percentage of participants
|
28.8 percentage of participants
|
29.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Drowsiness: First Dose (Day 1), Any
|
49.1 percentage of participants
|
48.1 percentage of participants
|
47.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Drowsiness: First Dose (Day 1), Mild
|
38.6 percentage of participants
|
32.7 percentage of participants
|
23.6 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Drowsiness: First Dose (Day 1), Severe
|
1.8 percentage of participants
|
1.9 percentage of participants
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Irritability: First Dose (Day 1), Any
|
56.1 percentage of participants
|
57.7 percentage of participants
|
58.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Irritability: First Dose (Day 1), Moderate
|
21.1 percentage of participants
|
19.2 percentage of participants
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Irritability: First Dose (Day 1), Severe
|
7.0 percentage of participants
|
9.6 percentage of participants
|
10.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Loss of Appetite: First Dose (Day 1), Any
|
29.8 percentage of participants
|
25.0 percentage of participants
|
21.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Loss of Appetite: First Dose (Day 1), Mild
|
26.3 percentage of participants
|
23.1 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Loss of Appetite: First Dose (Day 1), Moderate
|
3.5 percentage of participants
|
1.9 percentage of participants
|
12.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the Second Dose given on Day 29Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Drowsiness: Second Dose (Day 29), Any
|
30.4 percentage of participants
|
20.8 percentage of participants
|
36.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Drowsiness: Second Dose (Day 29), Mild
|
19.6 percentage of participants
|
18.8 percentage of participants
|
25.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Drowsiness: Second Dose (Day 29), Moderate
|
10.7 percentage of participants
|
2.1 percentage of participants
|
10.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Irritability: Second Dose (Day 29), Any
|
37.5 percentage of participants
|
33.3 percentage of participants
|
45.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Irritability: Second Dose (Day 29), Mild
|
19.6 percentage of participants
|
25.0 percentage of participants
|
30.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Irritability: Second Dose (Day 29), Moderate
|
10.7 percentage of participants
|
6.3 percentage of participants
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Irritability: Second Dose (Day 29), Severe
|
7.1 percentage of participants
|
2.1 percentage of participants
|
5.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Loss of Appetite: Second Dose (Day 29), Any
|
14.3 percentage of participants
|
10.4 percentage of participants
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Loss of Appetite: Second Dose (Day 29), Mild
|
12.5 percentage of participants
|
8.3 percentage of participants
|
16.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Loss of Appetite: Second Dose (Day 29), Moderate
|
1.8 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Loss of Appetite: Second Dose (Day 29), Severe
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days of the Third Dose given on Day 57Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Irritability: Third Dose (Day 57), Any
|
40.0 percentage of participants
|
26.1 percentage of participants
|
37.7 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Drowsiness: Third Dose (Day 57), Any
|
38.2 percentage of participants
|
21.7 percentage of participants
|
32.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Drowsiness: Third Dose (Day 57), Mild
|
25.5 percentage of participants
|
21.7 percentage of participants
|
26.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Drowsiness: Third Dose (Day 57), Moderate
|
12.7 percentage of participants
|
0 percentage of participants
|
5.7 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Irritability: Third Dose (Day 57), Mild
|
27.3 percentage of participants
|
21.7 percentage of participants
|
28.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Irritability: Third Dose (Day 57), Moderate
|
5.5 percentage of participants
|
2.2 percentage of participants
|
7.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Irritability: Third Dose (Day 57), Severe
|
7.3 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Loss of Appetite: Third Dose (Day 57), Any
|
10.9 percentage of participants
|
6.5 percentage of participants
|
13.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Loss of Appetite: Third Dose (Day 57), Mild
|
9.1 percentage of participants
|
6.5 percentage of participants
|
13.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Loss of Appetite: Third Dose (Day 57), Moderate
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the First Dose given on Day 1Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A systemic adverse event (AE) of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1
Fever: First Dose (Day 1), Any
|
15.8 percentage of participants
|
17.3 percentage of participants
|
23.6 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1
Fever: First Dose (Day 1), 38.0°C - 38.4°C
|
8.8 percentage of participants
|
9.6 percentage of participants
|
14.5 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1
Fever: First Dose (Day 1), 38.5°C - 38.9°C
|
7.0 percentage of participants
|
7.7 percentage of participants
|
9.1 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the Second Dose given on Day 29Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
Fever: Second Dose (Day 29), Any
|
7.1 percentage of participants
|
6.4 percentage of participants
|
14.8 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
Fever: Second Dose (Day 29), 38.0°C - 38.4°C
|
3.6 percentage of participants
|
2.1 percentage of participants
|
11.1 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
Fever: Second Dose (Day 29), 38.5°C - 38.9°C
|
3.6 percentage of participants
|
2.1 percentage of participants
|
3.7 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
Fever: Second Dose (Day 29), 39.0°C - 39.4°C
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 7 days of the Third Dose given on Day 57Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
Fever: Third Dose (Day 57), Any
|
9.1 percentage of participants
|
8.7 percentage of participants
|
15.4 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
Fever: Third Dose (Day 57), 38.0°C - 38.4°C
|
9.1 percentage of participants
|
6.5 percentage of participants
|
3.8 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
Fever: Third Dose (Day 57), 38.5°C - 38.9°C
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
Fever: Third Dose (Day 57), 39.0°C - 39.4°C
|
0 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
—
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
Fever: Third Dose (Day 57), 39.5°C - 39.9°C
|
0 percentage of participants
|
0 percentage of participants
|
1.9 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort
|
28.8 percentage of participants
|
28.3 percentage of participants
|
31.7 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 547Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort
|
13.6 percentage of participants
|
8.3 percentage of participants
|
8.3 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 85Population: Per-protocol set (PPS) in 'Infant Dose Ranging Cohort' included all participants in full analysis set (FAS) who had no major protocol violations. FAS included all participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at the given timepoint.
Seroconversion is defined as i) initially seronegative infants (titer \<8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=56 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=47 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=54 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=55 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Seroconversion
Sabin Type 1: Day 85
|
63.0 percentage of participants
Interval 48.7 to 75.7
|
77.8 percentage of participants
Interval 62.9 to 88.8
|
86.0 percentage of participants
Interval 73.3 to 94.2
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
|
Percentage of Participants With Seroconversion
Sabin Type 2: Day 85
|
68.5 percentage of participants
Interval 54.4 to 80.5
|
77.8 percentage of participants
Interval 62.9 to 88.8
|
90.0 percentage of participants
Interval 78.2 to 96.7
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
|
Percentage of Participants With Seroconversion
Sabin Type 3, Day 85
|
96.3 percentage of participants
Interval 87.3 to 99.5
|
100 percentage of participants
Interval 92.1 to 100.0
|
96.0 percentage of participants
Interval 86.3 to 99.5
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Percentage of Participants With Seroconversion
Salk Type 1: Day 85
|
37.0 percentage of participants
Interval 24.3 to 51.3
|
53.3 percentage of participants
Interval 37.9 to 68.3
|
68.0 percentage of participants
Interval 53.3 to 80.5
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Percentage of Participants With Seroconversion
Salk Type 2: Day 85
|
35.2 percentage of participants
Interval 22.7 to 49.4
|
55.6 percentage of participants
Interval 40.0 to 70.4
|
70.0 percentage of participants
Interval 55.4 to 82.1
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Percentage of Participants With Seroconversion
Salk Type 3: Day 85
|
90.7 percentage of participants
Interval 79.7 to 96.9
|
93.3 percentage of participants
Interval 81.7 to 98.6
|
94.0 percentage of participants
Interval 83.5 to 98.7
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
SECONDARY outcome
Timeframe: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm). Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Induration: Second Dose (Day 29), Any
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Third Dose (Day 57), Mild
|
33.9 percentage of participants
|
31.1 percentage of participants
|
34.0 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Swelling: Third Dose (Day 57), Any
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Third Dose (Day 57), Moderate
|
8.9 percentage of participants
|
8.9 percentage of participants
|
11.3 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Third Dose (Day 57), Severe
|
3.6 percentage of participants
|
4.4 percentage of participants
|
3.8 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Erythema: Third Dose (Day 57), Any
|
0 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Induration: Third Dose (Day 57), Any
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: First Dose (Day 1), Any
|
84.2 percentage of participants
|
69.2 percentage of participants
|
80.4 percentage of participants
|
86.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: First Dose (Day 1), Mild
|
26.3 percentage of participants
|
30.8 percentage of participants
|
41.1 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: First Dose (Day 1), Moderate
|
31.6 percentage of participants
|
17.3 percentage of participants
|
25.0 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: First Dose (Day 1), Severe
|
26.3 percentage of participants
|
21.2 percentage of participants
|
14.3 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Erythema: First Dose (Day 1), Any
|
5.3 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Induration: First Dose (Day 1), Any
|
1.8 percentage of participants
|
3.9 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Induration: First Dose (Day 1), Moderate
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Swelling: First Dose (Day 1), Any
|
1.8 percentage of participants
|
7.8 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Swelling: First Dose (Day 1), Moderate
|
0 percentage of participants
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Second Dose (Day 29), Any
|
48.2 percentage of participants
|
47.9 percentage of participants
|
61.8 percentage of participants
|
59.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Second Dose (Day 29), Mild
|
30.4 percentage of participants
|
25.0 percentage of participants
|
36.4 percentage of participants
|
45.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Second Dose (Day 29), Moderate
|
14.3 percentage of participants
|
16.7 percentage of participants
|
18.2 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Second Dose (Day 29), Severe
|
3.6 percentage of participants
|
6.3 percentage of participants
|
7.3 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Erythema: Second Dose (Day 29), Any
|
1.8 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Swelling: Second Dose (Day 29), Any
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Swelling: Second Dose (Day 29), Mild
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Pain: Third Dose (Day 57), Any
|
46.4 percentage of participants
|
44.4 percentage of participants
|
49.1 percentage of participants
|
60.7 percentage of participants
|
SECONDARY outcome
Timeframe: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: First Dose (Day 1), Any
|
56.1 percentage of participants
|
57.7 percentage of participants
|
58.2 percentage of participants
|
61.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Second Dose (Day 29), Any
|
37.5 percentage of participants
|
33.3 percentage of participants
|
45.5 percentage of participants
|
38.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Third Dose (Day 57), Any
|
40.0 percentage of participants
|
26.1 percentage of participants
|
37.7 percentage of participants
|
33.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Third Dose (Day 57), Moderate
|
5.5 percentage of participants
|
2.2 percentage of participants
|
7.5 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Third Dose (Day 57), Severe
|
7.3 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Third Dose (Day 57), Any
|
10.9 percentage of participants
|
6.5 percentage of participants
|
13.2 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Third Dose (Day 57), Mild
|
9.1 percentage of participants
|
6.5 percentage of participants
|
13.2 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Third Dose (Day 57), Moderate
|
1.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Third Dose (Day 57), Severe
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: First Dose (Day 1), Any
|
49.1 percentage of participants
|
48.1 percentage of participants
|
47.3 percentage of participants
|
44.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: First Dose (Day 1), Mild
|
38.6 percentage of participants
|
32.7 percentage of participants
|
23.6 percentage of participants
|
26.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: First Dose (Day 1), Moderate
|
8.8 percentage of participants
|
13.5 percentage of participants
|
21.8 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: First Dose (Day 1), Severe
|
1.8 percentage of participants
|
1.9 percentage of participants
|
1.8 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: First Dose (Day 1), Mild
|
28.1 percentage of participants
|
28.8 percentage of participants
|
29.1 percentage of participants
|
28.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: First Dose (Day 1), Moderate
|
21.1 percentage of participants
|
19.2 percentage of participants
|
18.2 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: First Dose (Day 1), Severe
|
7.0 percentage of participants
|
9.6 percentage of participants
|
10.9 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: First Dose (Day 1), Any
|
29.8 percentage of participants
|
25.0 percentage of participants
|
21.8 percentage of participants
|
19.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: First Dose (Day 1), Mild
|
26.3 percentage of participants
|
23.1 percentage of participants
|
9.1 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: First Dose (Day 1), Moderate
|
3.5 percentage of participants
|
1.9 percentage of participants
|
12.7 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Second Dose (Day 29), Any
|
30.4 percentage of participants
|
20.8 percentage of participants
|
36.4 percentage of participants
|
29.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Second Dose (Day 29), Mild
|
19.6 percentage of participants
|
18.8 percentage of participants
|
25.5 percentage of participants
|
22.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Second Dose (Day 29), Moderate
|
10.7 percentage of participants
|
2.1 percentage of participants
|
10.9 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Second Dose (Day 29), Mild
|
19.6 percentage of participants
|
25.0 percentage of participants
|
30.9 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Second Dose (Day 29), Moderate
|
10.7 percentage of participants
|
6.3 percentage of participants
|
9.1 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Second Dose (Day 29), Severe
|
7.1 percentage of participants
|
2.1 percentage of participants
|
5.5 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Second Dose (Day 29), Any
|
14.3 percentage of participants
|
10.4 percentage of participants
|
18.2 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Second Dose (Day 29), Mild
|
12.5 percentage of participants
|
8.3 percentage of participants
|
16.4 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Second Dose (Day 29), Moderate
|
1.8 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Loss of Appetite: Second Dose (Day 29), Severe
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Third Dose (Day 57), Any
|
38.2 percentage of participants
|
21.7 percentage of participants
|
32.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Third Dose (Day 57), Mild
|
25.5 percentage of participants
|
21.7 percentage of participants
|
26.4 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Drowsiness: Third Dose (Day 57), Moderate
|
12.7 percentage of participants
|
0 percentage of participants
|
5.7 percentage of participants
|
8.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Irritability: Third Dose (Day 57), Mild
|
27.3 percentage of participants
|
21.7 percentage of participants
|
28.3 percentage of participants
|
26.8 percentage of participants
|
SECONDARY outcome
Timeframe: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: First Dose (Day 1), Any
|
15.8 percentage of participants
|
17.3 percentage of participants
|
23.6 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: First Dose (Day 1), 38.0°C - 38.4°C
|
8.8 percentage of participants
|
9.6 percentage of participants
|
14.5 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: First Dose (Day 1), 38.5°C - 38.9°C
|
7.0 percentage of participants
|
7.7 percentage of participants
|
9.1 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: First Dose (Day 1), >= 40.0°C
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Second Dose (Day 29), Any
|
7.1 percentage of participants
|
6.4 percentage of participants
|
14.8 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Second Dose (Day 29), 38.0°C - 38.4°C
|
3.6 percentage of participants
|
2.1 percentage of participants
|
11.1 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Second Dose (Day 29), 38.5°C - 38.9°C
|
3.6 percentage of participants
|
2.1 percentage of participants
|
3.7 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Second Dose (Day 29), 39.0°C - 39.4°C
|
0 percentage of participants
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Third Dose (Day 57), 38.0°C - 38.4°C
|
9.1 percentage of participants
|
6.5 percentage of participants
|
3.8 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Third Dose (Day 57), 38.5°C - 38.9°C
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
5.4 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Third Dose (Day 57), 39.0°C - 39.4°C
|
0 percentage of participants
|
2.2 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Third Dose (Day 57), 39.5°C - 39.9°C
|
0 percentage of participants
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Fever: Third Dose (Day 57), Any
|
9.1 percentage of participants
|
8.7 percentage of participants
|
15.4 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Within 28 Days of primary vaccinations (Up to 85 days)Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
|
28.8 percentage of participants
|
28.3 percentage of participants
|
31.7 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 547Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort
|
13.6 percentage of participants
|
8.3 percentage of participants
|
8.3 percentage of participants
|
13.3 percentage of participants
|
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include drowsiness, irritability/fussiness, loss of appetite, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 28 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Percentage of participants with solicited local reactions on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include headache, asthenia, malaise, arthralgia, myalgia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 28 Days of booster vaccination given on Day 365Population: Study was terminated early, therefore data were not collected.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to Day 183Population: Safety Set in 'Toddlers Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=30 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=30 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days of sIPV or placebo vaccinationPopulation: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines. Only categories for which there was at least 1 participant are reported.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm).
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=20 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=20 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Pain: First Dose (Day 1), Any
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Pain: First Dose (Day 1), Mild
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Erythema: First Dose (Day 1), Any
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Induration: First Dose (Day 1), Any
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Induration: First Dose (Day 1), Mild
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Swelling: First Dose (Day 1), Any
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Swelling: First Dose (Day 1), Mild
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Pain: First Dose (Day 1), Moderate
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days of sIPV or placebo vaccinationPopulation: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
Solicited systemic AEs were collected by participants within 7 days after vaccination and included headache, asthenia, malaise, arthralgia and myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=20 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=20 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Headache: First Dose (Day 1), Any
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Headache: First Dose (Day 1), Mild
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Headache: First Dose (Day 1), Moderate
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Headache: First Dose (Day 1), Severe
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Malaise: First Dose (Day 1), Any
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Malaise: First Dose (Day 1), Mild
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Malaise: First Dose (Day 1), Moderate
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Arthralgia: First Dose (Day 1), Any
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Arthralgia: First Dose (Day 1), Mild
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Myalgia: First Dose (Day 1), Any
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Myalgia: First Dose (Day 1), Mild
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Myalgia: First Dose (Day 1), Moderate
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days of sIPV or placebo vaccination dose given on Day 1Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each immunization. Data is only reported for those categories with at least 1 participant.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=20 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=20 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Fever: First Dose (Day 1), Any
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Fever: First Dose (Day 1), 38.5°C - 38.9°C
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days of sIPV or placebo vaccinationPopulation: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=20 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=20 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 8Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=20 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=20 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 85, 365 and 393Population: Per-protocol set (PPS) included all participants in the full analysis set (FAS) who had no major protocol violations. The FAS included all participants who were randomized and received at least one dose of the trial vaccines. Study was early terminated, thus data for Days 365 and 393 are not reported.
SPR is defined as the percentage of participants with antibodies titers of poliovirus types 1, 2, and 3 for both Sabin and Salk strain ≥8.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=56 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=47 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=54 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=55 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 3: Day 85
|
98.1 percentage of participants
Interval 90.1 to 100.0
|
100 percentage of participants
Interval 92.3 to 100.0
|
98.0 percentage of participants
Interval 89.4 to 99.9
|
100 percentage of participants
Interval 93.3 to 100.0
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 1: Day 85
|
42.6 percentage of participants
Interval 29.2 to 56.8
|
56.5 percentage of participants
Interval 41.1 to 71.1
|
72.0 percentage of participants
Interval 57.5 to 83.8
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 2: Day 85
|
38.9 percentage of participants
Interval 25.9 to 53.1
|
65.2 percentage of participants
Interval 49.8 to 78.6
|
74.0 percentage of participants
Interval 59.7 to 85.4
|
100 percentage of participants
Interval 93.3 to 100.0
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 3: Day 85
|
92.6 percentage of participants
Interval 82.1 to 97.9
|
93.5 percentage of participants
Interval 82.1 to 98.6
|
96.0 percentage of participants
Interval 86.3 to 99.5
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 1: Day 85
|
72.2 percentage of participants
Interval 58.4 to 83.5
|
89.1 percentage of participants
Interval 76.4 to 96.4
|
88.0 percentage of participants
Interval 75.7 to 95.5
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 2: Day 85
|
83.3 percentage of participants
Interval 70.7 to 92.1
|
95.7 percentage of participants
Interval 85.2 to 99.5
|
100 percentage of participants
Interval 92.9 to 100.0
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
SECONDARY outcome
Timeframe: Days 85, 365 and 393Population: PPS in 'Infant Dose Ranging Cohort': participants in FAS who had no major protocol violations. FAS: participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at given timepoint. Study was early terminated, data for Days 365 and 393 are not reported.
GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.
Outcome measures
| Measure |
Infant Dose Ranging Cohort: sIPV Low Dose
n=56 Participants
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=47 Participants
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=54 Participants
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=55 Participants
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 1: Day 85
|
47.2 titer
Interval 28.2 to 78.8
|
105.6 titer
Interval 61.8 to 180.4
|
222.7 titer
Interval 130.6 to 379.7
|
155.0 titer
Interval 104.4 to 230.3
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 2: Day 85
|
53.2 titer
Interval 34.4 to 82.3
|
119.7 titer
Interval 74.2 to 192.9
|
205.1 titer
Interval 138.9 to 303.0
|
268.1 titer
Interval 188.4 to 381.5
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Sabin Type 3: Day 85
|
400.0 titer
Interval 267.3 to 598.4
|
748.2 titer
Interval 540.5 to 1035.7
|
844.6 titer
Interval 598.2 to 1192.5
|
533.8 titer
Interval 391.8 to 727.1
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 1: Day 85
|
11.7 titer
Interval 8.6 to 15.7
|
18.2 titer
Interval 11.5 to 28.9
|
27.5 titer
Interval 17.8 to 42.6
|
719.4 titer
Interval 520.9 to 993.7
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 3: Day 85
|
139.7 titer
Interval 83.7 to 233.2
|
257.9 titer
Interval 160.0 to 415.6
|
361.2 titer
Interval 230.4 to 566.2
|
456.2 titer
Interval 317.3 to 656.0
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Salk Type 2: Day 85
|
14.3 titer
Interval 9.7 to 21.2
|
22.4 titer
Interval 14.8 to 33.9
|
26.2 titer
Interval 18.2 to 37.6
|
400.1 titer
Interval 296.7 to 539.7
|
SECONDARY outcome
Timeframe: Day 393Population: As the study was early terminated the data was not collected at Day 393 for Vaccine Response Rate.
VRR is defined as percentage of participants i) seronegative prior to booster vaccination (titer \<8) having a titer ≥8, or ii) seropositive prior to booster vaccination (titer ≥8) having a 4-fold rise in antibody titers.
Outcome measures
Outcome data not reported
Adverse Events
Adult Lead-in Cohort: sIPV High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adult Lead-in Cohort: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toddler Lead-in Cohort: sIPV High Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Toddler Lead-in Cohort: Reference IPV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Infant Dose Ranging Cohort: sIPV Low Dose
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Infant Dose Ranging Cohort: sIPV Medium Dose
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
Infant Dose Ranging Cohort: sIPV High Dose
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Infant Dose Ranging Cohort: Reference IPV
Serious events: 8 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Adult Lead-in Cohort: sIPV High Dose
n=20 participants at risk
Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Adult Lead-in Cohort: Placebo
n=20 participants at risk
Placebo, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: sIPV High Dose
n=30 participants at risk
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: Reference IPV
n=30 participants at risk
Reference IPV, intramuscular injection on Day 1.
|
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 participants at risk
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 participants at risk
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 participants at risk
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 participants at risk
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
2/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
4/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
3/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
2/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Death
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
2/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
1/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Adult Lead-in Cohort: sIPV High Dose
n=20 participants at risk
Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Adult Lead-in Cohort: Placebo
n=20 participants at risk
Placebo, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: sIPV High Dose
n=30 participants at risk
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
|
Toddler Lead-in Cohort: Reference IPV
n=30 participants at risk
Reference IPV, intramuscular injection on Day 1.
|
Infant Dose Ranging Cohort: sIPV Low Dose
n=59 participants at risk
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV Medium Dose
n=60 participants at risk
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: sIPV High Dose
n=60 participants at risk
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
|
Infant Dose Ranging Cohort: Reference IPV
n=60 participants at risk
Reference IPV, intramuscular injection on Days 1, 29, 57 and 365.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
5/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
26.7%
8/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.3%
9/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
9/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.7%
13/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.7%
13/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
3/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
1/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
2/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.9%
7/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.7%
7/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
4/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
5/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/30 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.8%
4/59 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
3/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
3/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
3/60 • Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants
At each visit the investigator had to document any occurrence of non-serious adverse events and SAEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER