NCT03092791 is a Phase 1, PHASE2 clinical trial of Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) in Poliomyelitis, sponsored by Takeda.

Who is sponsoring NCT03092791?

NCT03092791 is sponsored by Takeda.

What condition does NCT03092791 study?

NCT03092791 studies Poliomyelitis.

Is NCT03092791 still recruiting?

NCT03092791 is currently terminated. Last updated 31 January 2020.

Are results published for NCT03092791?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-31 · How we verify

NCT03092791

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults

Terminated Phase 1, PHASE2 Results posted Last updated 31 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) in Poliomyelitis in 340 participants. Terminated before completion.

Timeline

7 June 2017

Primary endpoint
3 April 2018

18 October 2018

Quick facts

Lead sponsor	Takeda
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	340
Start date	7 June 2017
Primary completion	3 April 2018
Estimated completion	18 October 2018
Sites	4 locations across Panama

Drugs / interventions tested

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) — full drug profile →
Reference IPV — full drug profile →
sIPV Placebo

Conditions studied

Poliomyelitis — all drugs for Poliomyelitis →

Sponsor

Takeda — full company profile →

Who can join

Adults 6 Weeks to 49, any sex, with Poliomyelitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Within 7 days of the First Dose given on Day 1

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.

Pain: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	84.2
Infant Dose Ranging Cohort: sIPV Medium Dose	69.2
Infant Dose Ranging Cohort: sIPV High Dose	80.4

Pain: First Dose (Day 1), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	26.3
Infant Dose Ranging Cohort: sIPV Medium Dose	30.8
Infant Dose Ranging Cohort: sIPV High Dose	41.1

Pain: First Dose (Day 1), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	31.6
Infant Dose Ranging Cohort: sIPV Medium Dose	17.3
Infant Dose Ranging Cohort: sIPV High Dose	25.0

Pain: First Dose (Day 1), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	26.3
Infant Dose Ranging Cohort: sIPV Medium Dose	21.2
Infant Dose Ranging Cohort: sIPV High Dose	14.3

Erythema: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	5.3
Infant Dose Ranging Cohort: sIPV Medium Dose	1.9
Infant Dose Ranging Cohort: sIPV High Dose	0

Induration: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	1.8
Infant Dose Ranging Cohort: sIPV Medium Dose	3.9
Infant Dose Ranging Cohort: sIPV High Dose	0

Induration: First Dose (Day 1), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.0
Infant Dose Ranging Cohort: sIPV High Dose	0

Swelling: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	1.8
Infant Dose Ranging Cohort: sIPV Medium Dose	7.8
Infant Dose Ranging Cohort: sIPV High Dose	0

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 Primary · Within 7 days of the Second Dose given on Day 29

Pain: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	48.2
Infant Dose Ranging Cohort: sIPV Medium Dose	47.9
Infant Dose Ranging Cohort: sIPV High Dose	61.8

Pain: Second Dose (Day 29), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	30.4
Infant Dose Ranging Cohort: sIPV Medium Dose	25.0
Infant Dose Ranging Cohort: sIPV High Dose	36.4

Pain: Second Dose (Day 29), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	14.3
Infant Dose Ranging Cohort: sIPV Medium Dose	16.7
Infant Dose Ranging Cohort: sIPV High Dose	18.2

Pain: Second Dose (Day 29), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	3.6
Infant Dose Ranging Cohort: sIPV Medium Dose	6.3
Infant Dose Ranging Cohort: sIPV High Dose	7.3

Erythema: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	1.8
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	0

Induration: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	0

Swelling: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	4.2
Infant Dose Ranging Cohort: sIPV High Dose	0

Swelling: Second Dose (Day 29), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	0

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 Primary · Within 7 Days of the Third Dose given on Day 57

Pain: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	46.4
Infant Dose Ranging Cohort: sIPV Medium Dose	44.4
Infant Dose Ranging Cohort: sIPV High Dose	49.1

Pain: Third Dose (Day 57), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	33.9
Infant Dose Ranging Cohort: sIPV Medium Dose	31.1
Infant Dose Ranging Cohort: sIPV High Dose	34.0

Pain: Third Dose (Day 57), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	8.9
Infant Dose Ranging Cohort: sIPV Medium Dose	8.9
Infant Dose Ranging Cohort: sIPV High Dose	11.3

Pain: Third Dose (Day 57), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	3.6
Infant Dose Ranging Cohort: sIPV Medium Dose	4.4
Infant Dose Ranging Cohort: sIPV High Dose	3.8

Erythema: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.2
Infant Dose Ranging Cohort: sIPV High Dose	1.9

Swelling: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	1.8
Infant Dose Ranging Cohort: sIPV Medium Dose	0
Infant Dose Ranging Cohort: sIPV High Dose	0

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 Primary · Within 7 days of the First Dose given on Day 1

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: eat

Drowsiness: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	49.1
Infant Dose Ranging Cohort: sIPV Medium Dose	48.1
Infant Dose Ranging Cohort: sIPV High Dose	47.3

Drowsiness: First Dose (Day 1), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	38.6
Infant Dose Ranging Cohort: sIPV Medium Dose	32.7
Infant Dose Ranging Cohort: sIPV High Dose	23.6

Drowsiness: First Dose (Day 1), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	8.8
Infant Dose Ranging Cohort: sIPV Medium Dose	13.5
Infant Dose Ranging Cohort: sIPV High Dose	21.8

Drowsiness: First Dose (Day 1), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	1.8
Infant Dose Ranging Cohort: sIPV Medium Dose	1.9
Infant Dose Ranging Cohort: sIPV High Dose	1.8

Irritability: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	56.1
Infant Dose Ranging Cohort: sIPV Medium Dose	57.7
Infant Dose Ranging Cohort: sIPV High Dose	58.2

Irritability: First Dose (Day 1), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	28.1
Infant Dose Ranging Cohort: sIPV Medium Dose	28.8
Infant Dose Ranging Cohort: sIPV High Dose	29.1

Irritability: First Dose (Day 1), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	21.1
Infant Dose Ranging Cohort: sIPV Medium Dose	19.2
Infant Dose Ranging Cohort: sIPV High Dose	18.2

Irritability: First Dose (Day 1), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	7.0
Infant Dose Ranging Cohort: sIPV Medium Dose	9.6
Infant Dose Ranging Cohort: sIPV High Dose	10.9

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 Primary · Within 7 days of the Second Dose given on Day 29

Drowsiness: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	30.4
Infant Dose Ranging Cohort: sIPV Medium Dose	20.8
Infant Dose Ranging Cohort: sIPV High Dose	36.4

Drowsiness: Second Dose (Day 29), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	19.6
Infant Dose Ranging Cohort: sIPV Medium Dose	18.8
Infant Dose Ranging Cohort: sIPV High Dose	25.5

Drowsiness: Second Dose (Day 29), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	10.7
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	10.9

Irritability: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	37.5
Infant Dose Ranging Cohort: sIPV Medium Dose	33.3
Infant Dose Ranging Cohort: sIPV High Dose	45.5

Irritability: Second Dose (Day 29), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	19.6
Infant Dose Ranging Cohort: sIPV Medium Dose	25.0
Infant Dose Ranging Cohort: sIPV High Dose	30.9

Irritability: Second Dose (Day 29), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	10.7
Infant Dose Ranging Cohort: sIPV Medium Dose	6.3
Infant Dose Ranging Cohort: sIPV High Dose	9.1

Irritability: Second Dose (Day 29), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	7.1
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	5.5

Loss of Appetite: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	14.3
Infant Dose Ranging Cohort: sIPV Medium Dose	10.4
Infant Dose Ranging Cohort: sIPV High Dose	18.2

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 Primary · Within 7 Days of the Third Dose given on Day 57

Drowsiness: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	38.2
Infant Dose Ranging Cohort: sIPV Medium Dose	21.7
Infant Dose Ranging Cohort: sIPV High Dose	32.1

Drowsiness: Third Dose (Day 57), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	25.5
Infant Dose Ranging Cohort: sIPV Medium Dose	21.7
Infant Dose Ranging Cohort: sIPV High Dose	26.4

Drowsiness: Third Dose (Day 57), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	12.7
Infant Dose Ranging Cohort: sIPV Medium Dose	0
Infant Dose Ranging Cohort: sIPV High Dose	5.7

Irritability: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	40.0
Infant Dose Ranging Cohort: sIPV Medium Dose	26.1
Infant Dose Ranging Cohort: sIPV High Dose	37.7

Irritability: Third Dose (Day 57), Mild

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	27.3
Infant Dose Ranging Cohort: sIPV Medium Dose	21.7
Infant Dose Ranging Cohort: sIPV High Dose	28.3

Irritability: Third Dose (Day 57), Moderate

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	5.5
Infant Dose Ranging Cohort: sIPV Medium Dose	2.2
Infant Dose Ranging Cohort: sIPV High Dose	7.5

Irritability: Third Dose (Day 57), Severe

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	7.3
Infant Dose Ranging Cohort: sIPV Medium Dose	2.2
Infant Dose Ranging Cohort: sIPV High Dose	1.9

Loss of Appetite: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	10.9
Infant Dose Ranging Cohort: sIPV Medium Dose	6.5
Infant Dose Ranging Cohort: sIPV High Dose	13.2

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 Primary · Within 7 days of the First Dose given on Day 1

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.

Fever: First Dose (Day 1), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	15.8
Infant Dose Ranging Cohort: sIPV Medium Dose	17.3
Infant Dose Ranging Cohort: sIPV High Dose	23.6

Fever: First Dose (Day 1), 38.0°C - 38.4°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	8.8
Infant Dose Ranging Cohort: sIPV Medium Dose	9.6
Infant Dose Ranging Cohort: sIPV High Dose	14.5

Fever: First Dose (Day 1), 38.5°C - 38.9°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	7.0
Infant Dose Ranging Cohort: sIPV Medium Dose	7.7
Infant Dose Ranging Cohort: sIPV High Dose	9.1

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 Primary · Within 7 days of the Second Dose given on Day 29

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.

Fever: Second Dose (Day 29), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	7.1
Infant Dose Ranging Cohort: sIPV Medium Dose	6.4
Infant Dose Ranging Cohort: sIPV High Dose	14.8

Fever: Second Dose (Day 29), 38.0°C - 38.4°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	3.6
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	11.1

Fever: Second Dose (Day 29), 38.5°C - 38.9°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	3.6
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	3.7

Fever: Second Dose (Day 29), 39.0°C - 39.4°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.1
Infant Dose Ranging Cohort: sIPV High Dose	0

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 Primary · Within 7 days of the Third Dose given on Day 57

Fever: Third Dose (Day 57), Any

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	9.1
Infant Dose Ranging Cohort: sIPV Medium Dose	8.7
Infant Dose Ranging Cohort: sIPV High Dose	15.4

Fever: Third Dose (Day 57), 38.0°C - 38.4°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	9.1
Infant Dose Ranging Cohort: sIPV Medium Dose	6.5
Infant Dose Ranging Cohort: sIPV High Dose	3.8

Fever: Third Dose (Day 57), 38.5°C - 38.9°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	0
Infant Dose Ranging Cohort: sIPV High Dose	7.7

Fever: Third Dose (Day 57), 39.0°C - 39.4°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	2.2
Infant Dose Ranging Cohort: sIPV High Dose	1.9

Fever: Third Dose (Day 57), 39.5°C - 39.9°C

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	0
Infant Dose Ranging Cohort: sIPV Medium Dose	0
Infant Dose Ranging Cohort: sIPV High Dose	1.9

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 Primary · Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)

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.

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	28.8
Infant Dose Ranging Cohort: sIPV Medium Dose	28.3
Infant Dose Ranging Cohort: sIPV High Dose	31.7

Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort Primary · Day 1 up to Day 547

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.

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	13.6
Infant Dose Ranging Cohort: sIPV Medium Dose	8.3
Infant Dose Ranging Cohort: sIPV High Dose	8.3

Percentage of Participants With Seroconversion Primary · Day 85

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.

Sabin Type 1: Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	63.0	48.7 – 75.7
Infant Dose Ranging Cohort: sIPV Medium Dose	77.8	62.9 – 88.8
Infant Dose Ranging Cohort: sIPV High Dose	86.0	73.3 – 94.2
Infant Dose Ranging Cohort: Reference IPV	92.5	81.8 – 97.9

Sabin Type 2: Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	68.5	54.4 – 80.5
Infant Dose Ranging Cohort: sIPV Medium Dose	77.8	62.9 – 88.8
Infant Dose Ranging Cohort: sIPV High Dose	90.0	78.2 – 96.7
Infant Dose Ranging Cohort: Reference IPV	94.3	84.3 – 98.8

Sabin Type 3, Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	96.3	87.3 – 99.5
Infant Dose Ranging Cohort: sIPV Medium Dose	100	92.1 – 100
Infant Dose Ranging Cohort: sIPV High Dose	96.0	86.3 – 99.5
Infant Dose Ranging Cohort: Reference IPV	96.2	87.0 – 99.5

Salk Type 1: Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	37.0	24.3 – 51.3
Infant Dose Ranging Cohort: sIPV Medium Dose	53.3	37.9 – 68.3
Infant Dose Ranging Cohort: sIPV High Dose	68.0	53.3 – 80.5
Infant Dose Ranging Cohort: Reference IPV	96.2	87.0 – 99.5

Salk Type 2: Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	35.2	22.7 – 49.4
Infant Dose Ranging Cohort: sIPV Medium Dose	55.6	40.0 – 70.4
Infant Dose Ranging Cohort: sIPV High Dose	70.0	55.4 – 82.1
Infant Dose Ranging Cohort: Reference IPV	96.2	87.0 – 99.5

Salk Type 3: Day 85

Group	Value	95% CI
Infant Dose Ranging Cohort: sIPV Low Dose	90.7	79.7 – 96.9
Infant Dose Ranging Cohort: sIPV Medium Dose	93.3	81.7 – 98.6
Infant Dose Ranging Cohort: sIPV High Dose	94.0	83.5 – 98.7
Infant Dose Ranging Cohort: Reference IPV	94.3	84.3 – 98.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adult Lead-in Cohort: sIPV High Dose

Serious: 0/20 (0%)

Deaths: 0/20

Adult Lead-in Cohort: Placebo

Serious: 0/20 (0%)

Deaths: 0/20

Toddler Lead-in Cohort: sIPV High Dose

Serious: 0/30 (0%)

Deaths: 0/30

Toddler Lead-in Cohort: Reference IPV

Serious: 0/30 (0%)

Deaths: 0/30

Infant Dose Ranging Cohort: sIPV Low Dose

Serious: 8/59 (14%)

Deaths: 0/59

Infant Dose Ranging Cohort: sIPV Medium Dose

Serious: 5/60 (8%)

Deaths: 1/60

Infant Dose Ranging Cohort: sIPV High Dose

Serious: 5/60 (8%)

Deaths: 0/60

Infant Dose Ranging Cohort: Reference IPV

Serious: 8/60 (13%)

Deaths: 1/60

Serious adverse events (13 terms)

Reaction	System	Adult Lead-in Cohort: sIPV…	Adult Lead-in Cohort: Plac…	Toddler Lead-in Cohort: sI…	Toddler Lead-in Cohort: Re…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Meningitis aseptic	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Cyanosis	Cardiac disorders	—	—	—	—	—	—	—	—
Death	General disorders	—	—	—	—	—	—	—	—
Sudden infant death syndrome	General disorders	—	—	—	—	—	—	—	—
Milk allergy	Immune system disorders	—	—	—	—	—	—	—	—
Pharyngotonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Tracheitis	Infections and infestations	—	—	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Adult Lead-in Cohort: sIPV…	Adult Lead-in Cohort: Plac…	Toddler Lead-in Cohort: sI…	Toddler Lead-in Cohort: Re…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…	Infant Dose Ranging Cohort…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Bronchiolitis, Gastroenteritis, Bronchitis, Meningitis aseptic, Urinary tract infection, Cyanosis, Death.

Data from ClinicalTrials.gov NCT03092791 adverse events section.

Sponsor's own description

The purpose of this study is to select the optimal antigen dosage of the three Sabin poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent Sabin-based inactivated poliomyelitis vaccine (sIPV) to take forward into advanced stage studies. The selection will be carried out comparing the three sIPV study arms based on the safety and tolerability profile after each dose of primary immunization and the immune response to poliovirus types 1, 2, and 3 for both Sabin and Salk strains, after the final dose of a three dose primary immunization series (Day 85).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial.
Cramer JP, Jimeno J, Han HH, Lin S, et al · · 2020 · cited 8× · PMID 32563609 · DOI 10.1016/j.vaccine.2020.05.081

Verify or expand the search:

Other recruiting trials for Poliomyelitis

Currently open trials in the same condition.

NCT07457060 — Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine · Phase 4 · recruiting
NCT06895486 — Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation · Phase 2 · recruiting
NCT07354269 — Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations · Phase 4 · recruiting
NCT06137664 — Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines · Phase 1, PHASE2 · recruiting
NCT05644184 — Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh · Phase 2 · recruiting

Other Takeda trials

Trials by the same sponsor.

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NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03092791 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 31 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03092791.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing