Trial Outcomes & Findings for Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants (NCT NCT05033561)

Last Updated: 2024-08-23

Results Overview

Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

905 participants

Primary outcome timeframe

Up to max 8 weeks

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Administration of 2 doses of nOPV2, 1 week apart nOPV2: Novel Oral Poliomyelitis Type 2 Vaccine	Group B Administration of 2 doses of nOPV2, 2 weeks apart nOPV2: Novel Oral Poliomyelitis Type 2 Vaccine	Group C Administration of 2 doses of nOPV2, 4 weeks apart nOPV2: Novel Oral Poliomyelitis Type 2 Vaccine
Overall Study STARTED	302	300	303
Overall Study COMPLETED	297	297	298
Overall Study NOT COMPLETED	5	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=302 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=300 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=303 Participants Administration of 2 doses of nOPV2, 4 weeks apart	Total n=905 Participants Total of all reporting groups
Age, Categorical <=18 years	302 Participants n=5 Participants	300 Participants n=7 Participants	303 Participants n=5 Participants	905 Participants n=4 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
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	134 Participants n=5 Participants	138 Participants n=7 Participants	146 Participants n=5 Participants	418 Participants n=4 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	162 Participants n=7 Participants	157 Participants n=5 Participants	487 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Mixed Race	301 Participants n=5 Participants	299 Participants n=7 Participants	301 Participants n=5 Participants	901 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Dominican Republic	302 participants n=5 Participants	300 participants n=7 Participants	303 participants n=5 Participants	905 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to max 8 weeks

Population: Per Protocol population

Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age

Outcome measures

Outcome measures
Measure	Group A n=291 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=294 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=295 Participants Administration of 2 doses of nOPV2, 4 weeks apart
Seroconversion Rate at 1, 2 & 4 Weeks Interval	253 Participants	269 Participants	277 Participants

SECONDARY outcome

Timeframe: Up to max 8 weeks

Population: Per Protocol Population

Geometric mean titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1, 2 \& 4 weeks apart.

Outcome measures

Outcome measures
Measure	Group A n=291 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=294 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=295 Participants Administration of 2 doses of nOPV2, 4 weeks apart
Neutralizing Antibodies at 1, 2 & 4 Week Interval Day 0	10.7 titers Interval 8.5 to 13.5	11.5 titers Interval 9.0 to 14.7	10.2 titers Interval 8.1 to 12.9
Neutralizing Antibodies at 1, 2 & 4 Week Interval 28 days after 2nd dose	1232.3 titers Interval 909.0 to 1670.5	1726.3 titers Interval 1252.1 to 2380.1	2327.6 titers Interval 1654.3 to 3275.2

SECONDARY outcome

Timeframe: 6 months

Population: Total Vaccinated Population. Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.

Number of participants experiencing SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.

Outcome measures

Outcome measures
Measure	Group A n=298 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=304 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=303 Participants Administration of 2 doses of nOPV2, 4 weeks apart
Serious Adverse Events (SAEs) and Important Medical Events (IMEs) Death	0 Participants	0 Participants	1 Participants
Serious Adverse Events (SAEs) and Important Medical Events (IMEs) Hospitalization	8 Participants	7 Participants	9 Participants
Serious Adverse Events (SAEs) and Important Medical Events (IMEs) Birth defect	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to max 5 weeks

Number of participants experiencing mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.

Outcome measures

Outcome measures
Measure	Group A n=294 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=304 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=303 Participants Administration of 2 doses of nOPV2, 4 weeks apart
Solicited Adverse Events (AEs) Abnormal crying	84 Participants	90 Participants	83 Participants
Solicited Adverse Events (AEs) Diarrhea	44 Participants	50 Participants	40 Participants
Solicited Adverse Events (AEs) Drowsiness	25 Participants	38 Participants	36 Participants
Solicited Adverse Events (AEs) Fever	134 Participants	147 Participants	139 Participants
Solicited Adverse Events (AEs) Irritability	31 Participants	45 Participants	41 Participants
Solicited Adverse Events (AEs) Loss of Apetite	36 Participants	49 Participants	38 Participants
Solicited Adverse Events (AEs) Vomiting	45 Participants	75 Participants	62 Participants

SECONDARY outcome

Timeframe: Up to max 8 weeks

Population: Total Vaccinated Population. Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan (SAP). Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.

Number of participants experiencing mild, moderate, and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea, and irritability) for 28 days after each dose of study vaccine in all groups.

Outcome measures

Outcome measures
Measure	Group A n=298 Participants Administration of 2 doses of nOPV2, 1 week apart	Group B n=304 Participants Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=303 Participants Administration of 2 doses of nOPV2, 4 weeks apart
Unsolicited Adverse Events (AEs) Respiratory disorders	13 Participants	10 Participants	11 Participants
Unsolicited Adverse Events (AEs) Infections	9 Participants	10 Participants	14 Participants
Unsolicited Adverse Events (AEs) Gastrointestinal disorders	3 Participants	13 Participants	9 Participants
Unsolicited Adverse Events (AEs) Musculoskeletal and connective tissue disorders	0 Participants	0 Participants	3 Participants
Unsolicited Adverse Events (AEs) Skin disorders	0 Participants	2 Participants	1 Participants
Unsolicited Adverse Events (AEs) Congenital disorders	0 Participants	1 Participants	1 Participants
Unsolicited Adverse Events (AEs) Nervous system disorders	0 Participants	1 Participants	0 Participants
Unsolicited Adverse Events (AEs) General disorders	1 Participants	8 Participants	6 Participants

Adverse Events

Group A

Serious events: 8 serious events

Other events: 217 other events

Deaths: 0 deaths

Group B

Serious events: 7 serious events

Other events: 247 other events

Deaths: 0 deaths

Group C

Serious events: 9 serious events

Other events: 238 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Group A n=298 participants at risk Administration of 2 doses of nOPV2, 1 week apart	Group B n=304 participants at risk Administration of 2 doses of nOPV2, 2 weeks apart	Group C n=303 participants at risk Administration of 2 doses of nOPV2, 4 weeks apart
Infections and infestations Pneumonia	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.66% 2/304 • Number of events 2 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	1.7% 5/303 • Number of events 5 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Bronchiolitis	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.99% 3/304 • Number of events 3 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Amoebic dysentery	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/303 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Dengue fever	0.67% 2/298 • Number of events 2 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Abscess neck	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/304 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Gastroenteritis	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Herpes virus infection	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/303 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Osteomyelitis	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Sepsis	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/303 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Infections and infestations Septic shock	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/303 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Congenital, familial and genetic disorders Hereditary haemolytic anemia	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/303 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Congenital, familial and genetic disorders Hereditary spherocytosis	0.00% 0/298 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.33% 1/304 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.
Gastrointestinal disorders Inguinal hernia	0.34% 1/298 • Number of events 1 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/304 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.	0.00% 0/303 • 6 months Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.

Other adverse events

Additional Information

Ricardo Rüttimann

FIDEC Corporation

Phone: +5491161188536

Email: [email protected]

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