Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children (NCT NCT02521974)

Results Overview

Number of subjects experiencing SAEs, severe AEs (grade 3), and IMEs considered consistent with a causal association to study vaccine throughout the study period in all groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

164 participants

Primary outcome timeframe

6 months

Results posted on

2020-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.	Group 2+3 18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
Overall Study STARTED	50	114
Overall Study COMPLETED	47	110
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=50 Participants 1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.	Group 2+3 n=110 Participants 18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose/s of the investigational vaccine.	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	110 Participants n=7 Participants	160 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	49 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	61 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	50 Participants n=5 Participants	110 Participants n=7 Participants	160 Participants n=5 Participants
Region of Enrollment Panama	50 Participants n=5 Participants	110 Participants n=7 Participants	160 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 50 (100%) children in Group 1 received the first dose of study vaccine and 47 (94%) children received the second dose. All 110 (100%) infants in combined Groups 2+3 received the first dose of study vaccine and 49 (98.0%) of the 50 infants in Group 3 received 2 doses of vaccine.

Number of subjects experiencing SAEs, severe AEs (grade 3), and IMEs considered consistent with a causal association to study vaccine throughout the study period in all groups.

Outcome measures

Outcome measures
Measure	Group 1 n=50 Participants 1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.	Group 2+3 n=110 Participants 18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
Number of Subjects Experiencing SAEs, Severe AEs (Grade 3), and/or IMEs	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 28 days

Population: TVP is 110 while PP is 97 - per protocol the PP population will be used for immunogenicity analysis.

Measured at Day 28 following a single dose of Sabin mOPV2 in both infant groups (Groups 2+3). Seroprotection is defined as type 2-specific antibody titers ≥1:8 and seroprotection rate as the percentage of seroprotected subjects per group.

Outcome measures

Outcome measures
Measure	Group 1 n=97 Participants 1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.	Group 2+3 18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.	91 Participants	—

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2+3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 n=50 participants at risk 1-5 years old children who had previously been fully vaccinated with OPV and/or IPV and who will received 2 doses of the investigational vaccine.	Group 2+3 n=114 participants at risk 18 - 22 weeks old infants who will first receive bOPV/IPV coverage and one / two dose / s of the investigational vaccine.
General disorders Abnormal crying	0.00% 0/50	0.88% 1/114
General disorders Irritability	2.0% 1/50	0.88% 1/114

Additional Information

Ricardo Rüttimann

FIDEC Corporationa

Phone: +17863546335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place