Trial Outcomes & Findings for A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2 (NCT NCT05677256)
NCT ID: NCT05677256
Last Updated: 2026-09-03
Results Overview
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
COMPLETED
PHASE4
501 participants
1 month
2026-09-03
Participant Flow
500 participants started the study, while 501 signed the informed consent. One of them resulted in Screening Failure.
Participant milestones
| Measure |
IPV-primed Group
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
COMPLETED
|
238
|
232
|
|
Overall Study
NOT COMPLETED
|
12
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2
Baseline characteristics by cohort
| Measure |
IPV-primed Group
n=250 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=250 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
250 Participants
n=136 Participants
|
250 Participants
n=136 Participants
|
500 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=136 Participants
|
120 Participants
n=136 Participants
|
254 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=136 Participants
|
130 Participants
n=136 Participants
|
246 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
250 Participants
n=136 Participants
|
250 Participants
n=136 Participants
|
500 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
Bangladesh
|
250 participants
n=136 Participants
|
250 participants
n=136 Participants
|
500 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The primary population for the virological analyses was the Viral Shedding Population (VSP) which consisted of all PP Population members who did not contribute a type-2 positive pharyngeal, nasal or stool sample prior to receipt of the nOPV2 challenge dose.
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
Outcome measures
| Measure |
IPV-primed Group
n=234 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=229 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR.
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The primary population for the analysis of immunogenicity was the Per-Protocol (PP) Population.
To assess and compare the pharyngeal NAbs poliovirus type-2 activity on D0, D14 and D28 in both groups.
Outcome measures
| Measure |
IPV-primed Group
n=234 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=230 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
Day 0
|
2.07 mcg/ml
Interval 1.48 to 2.91
|
0.07 mcg/ml
Interval 0.0 to 5.24
|
|
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
Day 14
|
7.54 mcg/ml
Interval 5.12 to 11.09
|
0.63 mcg/ml
Interval 0.32 to 1.25
|
|
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
Day 28
|
7.72 mcg/ml
Interval 5.39 to 11.05
|
0.82 mcg/ml
Interval 0.46 to 1.47
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: The primary population for the analysis of immunogenicity was the Per-Protocol (PP) Population.
To assess the humoral immunogenicity to poliovirus type-2 at D0, 4 and 8 weeks following administration of a challenge dose of nOPV2 in both groups. Seroprotection is defined as neutralizing type-2 poliovirus antibody specific titers ≥1:8.
Outcome measures
| Measure |
IPV-primed Group
n=234 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=230 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
Day 0
|
99.1 percentage of participants
Interval 96.9 to 99.9
|
20.6 percentage of participants
Interval 15.6 to 26.5
|
|
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
Day 28
|
99.1 percentage of participants
Interval 96.9 to 99.9
|
73.6 percentage of participants
Interval 67.3 to 79.2
|
|
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
Day 56
|
97.8 percentage of participants
Interval 94.9 to 99.3
|
68.8 percentage of participants
Interval 62.2 to 74.8
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: The primary population for the analysis of safety was the EP.
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.
Outcome measures
| Measure |
IPV-primed Group
n=250 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=250 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: The primary population for the analysis of immunogenicity was the Per-Protocol (PP) Population.
To asses and compare the pharyngeal mucosal immunoglobulin class-specific immune response to poliovirus type-2 at Day 0, 2 and 4 weeks following administration of a challenge dose of nOPV2 in both groups.This is measured in geometric mean concentrations (GMCs) in nasal samples on D0, D14 and D28 in both groups.
Outcome measures
| Measure |
IPV-primed Group
n=234 Participants
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=230 Participants
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
D0
|
857.66 mcg/ml
Interval 756.53 to 972.32
|
919.34 mcg/ml
Interval 797.95 to 1059.2
|
|
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
D14
|
886.20 mcg/ml
Interval 783.75 to 1002.04
|
888.07 mcg/ml
Interval 774.03 to 1018.9
|
|
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
D28
|
769.36 mcg/ml
Interval 674.75 to 877.24
|
849.08 mcg/ml
Interval 752.85 to 957.61
|
Adverse Events
IPV-primed Group
bOPV-primed Group
Serious adverse events
| Measure |
IPV-primed Group
n=250 participants at risk
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
bOPV-primed Group
n=250 participants at risk
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
nOPV2: Vaccination
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
3/250 • Number of events 3 • 6 months
|
0.00%
0/250 • 6 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.40%
1/250 • Number of events 1 • 6 months
|
0.00%
0/250 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/250 • 6 months
|
0.40%
1/250 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
1/250 • Number of events 1 • 6 months
|
0.00%
0/250 • 6 months
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/250 • 6 months
|
0.40%
1/250 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI and/or the Institution are not entitled to publish or present any study information, either partial or complete, without written approval by FIDEC.
- Publication restrictions are in place
Restriction type: OTHER