Adults 5 Weeks to 7 Weeks, 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.
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IMPrimary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group B
98.1
94.6 – 99.6
Group D
95.9
92.1 – 98.2
Serotype 2
Group
Value
95% CI
Group B
98.7
95.5 – 99.8
Group D
97.9
94.8 – 99.4
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IMPrimary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group A
100
97.9 – 100
Group B
98.1
94.6 – 99.6
Serotype 2
Group
Value
95% CI
Group A
100
97.9 – 100
Group B
98.7
95.5 – 99.8
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV IDPrimary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group C
98.8
95.6 – 98.8
Group D
95.9
92.1 – 98.2
Serotype 2
Group
Value
95% CI
Group C
100
97.7 – 100
Group D
97.9
94.8 – 99.4
Seroconversion Superiority of 2 Doses IPV IM at Different SchedulesSecondary· To be assessed 4 weeks after the second dose
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.
Serotype 1
Group
Value
95% CI
Group A
95.6
94.6 – 99.6
Group B
98.1
94.6 – 99.6
Serotype 2
Group
Value
95% CI
Group A
88.9
83.4 – 93.1
Group B
98.7
95.5 – 99.8
Seroconversion Superiority of 2 Dose f-IPV ID at Different SchedulesSecondary· To be assessed 4 weeks after the second dose
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.
Serotype 1
Group
Value
95% CI
Group C
83.2
76.5 – 88.6
Group D
95.9
92.1 – 98.2
Serotype 2
Group
Value
95% CI
Group C
83.9
77.2 – 89.2
Group D
97.9
94.8 – 99.4
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IMSecondary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group A
100
97.9 – 100
Group D
95.9
92.1 – 98.2
Serotype 2
Group
Value
95% CI
Group A
100
97.9 – 100
Group D
97.9
94.8 – 99.4
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IMSecondary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group A
100
97.9 – 100
Group C
98.8
95.6 – 99.8
Serotype 2
Group
Value
95% CI
Group A
100
97.9 – 100
Group C
100
97.7 – 100
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IMSecondary· To be assessed 4 weeks after the last dose
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.
Serotype 1
Group
Value
95% CI
Group B
98.1
94.6 – 99.6
Group C
98.8
95.6 – 99.8
Serotype 2
Group
Value
95% CI
Group B
98.7
95.5 – 99.8
Group C
100
97.7 – 100
Number of Participants Experiencing SAEs, IMEs and/or Severe Local ReactionsSecondary· 9 months
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).
SAE
Group
Value
95% CI
Group A
10
Group B
6
Group C
7
Group D
9
IME
Group
Value
95% CI
Group A
4
Group B
0
Group C
2
Group D
2
SLR
Group
Value
95% CI
Group A
0
Group B
0
Group C
0
Group D
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06331156 — A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavi
· Phase 3
· completed
NCT04481191 — Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyel
· Phase 3
· completed
NCT04063150 — Immunogenicity of Intramuscular and Intradermal IPV
· Phase 4
· terminated
NCT03530124 — Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
· Phase 4
· completed
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 Fidec Corporation trials
Trials by the same sponsor.
NCT07010822 — A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinate
· Phase 3
· not yet recruiting
NCT05677256 — A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2
· Phase 4
· completed
NCT05033561 — Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
· Phase 3
· completed
NCT03554798 — A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine
· Phase 2
· completed
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 Fidec Corporation
Last refreshed: 21 July 2023
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/NCT03239496.