Trial Outcomes & Findings for A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV (NCT NCT03239496)
NCT ID: NCT03239496
Last Updated: 2023-07-21
Results Overview
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
773 participants
Primary outcome timeframe
To be assessed 4 weeks after the last dose
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
Group A - 3 Doses IPV IM
3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group B - 2 Doses IPV IM
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C - 3 Doses f-IPV
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D - 2 Doses f-IPV ID
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
200
|
178
|
178
|
217
|
|
Overall Study
COMPLETED
|
186
|
168
|
166
|
203
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
12
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Baseline characteristics by cohort
| Measure |
Group A
n=200 Participants
3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group B
n=178 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
n=178 Participants
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=217 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Total
n=773 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
200 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
773 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
372 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
401 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
105 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
446 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
88 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
303 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
Panama
|
112 participants
n=5 Participants
|
82 participants
n=7 Participants
|
93 participants
n=5 Participants
|
100 participants
n=4 Participants
|
387 participants
n=21 Participants
|
|
Region of Enrollment
Dominican Republic
|
88 participants
n=5 Participants
|
96 participants
n=7 Participants
|
85 participants
n=5 Participants
|
117 participants
n=4 Participants
|
386 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population (692 subjects) is used for this assessment. The participants flow includes the Intended to Treat population (773 subjects).
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=159 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=195 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
Serotype 1
|
98.1 percentage of seroconversion
Interval 94.6 to 99.6
|
95.9 percentage of seroconversion
Interval 92.1 to 98.2
|
—
|
—
|
|
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
Serotype 2
|
98.7 percentage of seroconversion
Interval 95.5 to 99.8
|
97.9 percentage of seroconversion
Interval 94.8 to 99.4
|
—
|
—
|
PRIMARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=159 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=178 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
Serotype 1
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
98.1 percentage of seroconversion
Interval 94.6 to 99.6
|
—
|
—
|
|
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
Serotype 2
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
98.7 percentage of seroconversion
Interval 95.5 to 99.8
|
—
|
—
|
PRIMARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=160 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=195 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
Serotype 1
|
98.8 percentage of seroconversion
Interval 95.6 to 98.8
|
95.9 percentage of seroconversion
Interval 92.1 to 98.2
|
—
|
—
|
|
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
Serotype 2
|
100 percentage of seroconversion
Interval 97.7 to 100.0
|
97.9 percentage of seroconversion
Interval 94.8 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: To be assessed 4 weeks after the second dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=180 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=159 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
Serotype 1
|
95.6 percentage of seroconversion
Interval 94.6 to 99.6
|
98.1 percentage of seroconversion
Interval 94.6 to 99.6
|
—
|
—
|
|
Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
Serotype 2
|
88.9 percentage of seroconversion
Interval 83.4 to 93.1
|
98.7 percentage of seroconversion
Interval 95.5 to 99.8
|
—
|
—
|
SECONDARY outcome
Timeframe: To be assessed 4 weeks after the second dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=161 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=195 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
Serotype 1
|
83.2 percentage of seroconversion
Interval 76.5 to 88.6
|
95.9 percentage of seroconversion
Interval 92.1 to 98.2
|
—
|
—
|
|
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
Serotype 2
|
83.9 percentage of seroconversion
Interval 77.2 to 89.2
|
97.9 percentage of seroconversion
Interval 94.8 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=178 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=195 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
Serotype 1
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
95.9 percentage of seroconversion
Interval 92.1 to 98.2
|
—
|
—
|
|
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
Serotype 2
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
97.9 percentage of seroconversion
Interval 94.8 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population
To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=178 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=160 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
Serotype 1
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
98.8 percentage of seroconversion
Interval 95.6 to 99.8
|
—
|
—
|
|
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
Serotype 2
|
100 percentage of seroconversion
Interval 97.9 to 100.0
|
100 percentage of seroconversion
Interval 97.7 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: To be assessed 4 weeks after the last dosePopulation: Per Protocol Population
To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Outcome measures
| Measure |
Group B
n=159 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=160 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
Serotype 1
|
98.1 percentage of seroconversion
Interval 94.6 to 99.6
|
98.8 percentage of seroconversion
Interval 95.6 to 99.8
|
—
|
—
|
|
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
Serotype 2
|
98.7 percentage of seroconversion
Interval 95.5 to 99.8
|
100 percentage of seroconversion
Interval 97.7 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Total Vaccinated Population (744 subjects) is used for safety analysis. The participants flow indicate the Intended To Treat population (773 subjects).
To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).
Outcome measures
| Measure |
Group B
n=195 Participants
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=172 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
n=170 Participants
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=207 Participants
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
SAE
|
10 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
IME
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
SLR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group A
Serious events: 12 serious events
Other events: 7 other events
Deaths: 1 deaths
Group B
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 9 serious events
Other events: 4 other events
Deaths: 0 deaths
Group D
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=195 participants at risk
3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group B
n=172 participants at risk
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
n=170 participants at risk
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=207 participants at risk
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
1.7%
3/172 • Number of events 3 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
2.4%
4/170 • Number of events 5 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.97%
2/207 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Bronchiolitis
|
1.0%
2/195 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.97%
2/207 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
1.2%
2/170 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.48%
1/207 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.58%
1/172 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
2/195 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.58%
1/172 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Otitis media
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Pertussis
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.48%
1/207 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.48%
1/207 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Congenital, familial and genetic disorders
Adrenogenital syndrome
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Congenital, familial and genetic disorders
Glucose-6-Phosphate Dehydrogenase Deficiency
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.58%
1/172 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.48%
1/207 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.48%
1/207 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.58%
1/172 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Cow milk intolerance
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
Other adverse events
| Measure |
Group A
n=195 participants at risk
3 doses IPV IM at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group B
n=172 participants at risk
2 doses IPV IM at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group C
n=170 participants at risk
3 doses f-IPV ID at 10, 14 \& 36 weeks of age incl. blood sampling at 10, 14, 18 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Group D
n=207 participants at risk
2 doses f-IPV ID at 14 \& 36 weeks of age incl. blood sampling at 14, 18, 36 \& 40 weeks.
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
1.5%
3/195 • Number of events 4 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.97%
2/207 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Infections and infestations
Febrile convulsion
|
1.0%
2/195 • Number of events 2 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Metabolism and nutrition disorders
Cow milk intolerance
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.51%
1/195 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/170 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/195 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/172 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.59%
1/170 • Number of events 1 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
0.00%
0/207 • 9 months
The Total Vaccinated Population (744 subjects) was used for safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place