Trial Outcomes & Findings for A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age (NCT NCT02580201)

Last Updated: 2023-04-18

Results Overview

Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

154 participants

Primary outcome timeframe

6 months

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Group1 tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Overall Study STARTED	50	104
Overall Study COMPLETED	50	104
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=50 Participants tOPV-vaccinated healthy children aged 1 to 5 years to receive 1 dose of SABIN	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	104 Participants n=7 Participants	154 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/Gender, Customized Female	23 Participants n=5 Participants	56 Participants n=7 Participants	79 Participants n=5 Participants
Sex/Gender, Customized Male	27 Participants n=5 Participants	48 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	104 Participants n=7 Participants	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Dominican Republic	50 Participants n=5 Participants	104 Participants n=7 Participants	154 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Total vaccinated population (TVP)

Outcome measures

Outcome measures
Measure	Group1 n=50 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
SAEs and AEs G3	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Per Protocol Population (PP)

Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).

Outcome measures

Outcome measures
Measure	Group1 n=104 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Seroprotection Rate Serotype 1	93.3 percentage of participants Interval 86.6 to 97.3	—
Seroprotection Rate Serotype 2	100 percentage of participants Interval 96.5 to 100.0	—
Seroprotection Rate Serotype 3	96.2 percentage of participants Interval 90.4 to 98.9	—

SECONDARY outcome

Timeframe: 3 months

Population: Per Protocol Population (PP)

Median titers of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).

Outcome measures

Outcome measures
Measure	Group1 n=49 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Neutralizing Antibodies 1 Serotype 1	10.50 log^2 Interval 9.17 to 10.5	10.50 log^2 Interval 9.17 to 10.5
Neutralizing Antibodies 1 Serotype 2	9.83 log^2 Interval 9.5 to 10.5	10.17 log^2 Interval 9.83 to 10.17
Neutralizing Antibodies 1 Serotype 3	8.50 log^2 Interval 7.83 to 9.5	8.83 log^2 Interval 8.5 to 9.5

SECONDARY outcome

Timeframe: 3 months

Population: Per protocol population (PP)

Seroconversion rate of type-specific neutralizing antibodies at Day 28 for Group 1, and at Day 84 for Group 2.

Outcome measures

Outcome measures
Measure	Group1 n=49 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Seroconversion Rate Serotype 1	32.7 percentage of participants Interval 19.9 to 47.5	88.5 percentage of participants Interval 80.7 to 93.9
Seroconversion Rate Serotype 2	36.7 percentage of participants Interval 23.4 to 51.7	98.1 percentage of participants Interval 93.2 to 99.8
Seroconversion Rate Serotype 3	46.9 percentage of participants Interval 32.5 to 61.7	96.2 percentage of participants Interval 90.4 to 98.9

SECONDARY outcome

Timeframe: 3 months

Population: Per Protocol Population

Geometric mean antibody titers (GMT) of type-specific neutralizing antibodies at Days 0 and 28 in children aged 1-5 years (Group 1), and at Days 0 and 84 in infants (Group 2).

Outcome measures

Outcome measures
Measure	Group1 n=49 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Neutralizing Antibodies 2 Serotype 1	445.5 GMTs Interval 272.7 to 710.6	650.8 GMTs Interval 473.7 to 870.6
Neutralizing Antibodies 2 Serotype 2	681.2 GMTs Interval 511.1 to 882.9	712.2 GMTs Interval 594.4 to 840.3
Neutralizing Antibodies 2 Serotype 3	306.3 GMTs Interval 201.7 to 452.0	352.1 GMTs Interval 263.9 to 462.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Per Protocol Population

Seroprotection rates of type-specific neutralizing antibodies at Days 0 and 28 in Group 1 and at Day 0 in Group 2.

Outcome measures

Outcome measures
Measure	Group1 n=49 Participants tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 Participants Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Seroprotection Rates Serotype 3	98 percentage of participants Interval 89.1 to 99.9	26 percentage of participants Interval 17.9 to 35.5
Seroprotection Rates Serotype 1	93.0 percentage of participants Interval 83.1 to 98.7	60.6 percentage of participants Interval 50.5 to 70.0
Seroprotection Rates Serotype 2	100 percentage of participants Interval 92.7 to 100.0	60.6 percentage of participants Interval 50.5 to 70.0

Adverse Events

Group1

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Ricardo Rüttimann

FIDEC Corporation

Phone: +17863546335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group1 n=50 participants at risk tOPV-vaccinated healthy children to receive 1 dose of SABIN tOPV	Group 2 n=104 participants at risk Vaccine-naïve infants to receive 3 doses of SABIN tOPV administered 28 days apart.
Gastrointestinal disorders Appetite lost	2.0% 1/50 • Number of events 2 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	2.9% 3/104 • Number of events 8 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
General disorders Abnormal crying	2.0% 1/50 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	4.8% 5/104 • Number of events 20 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
General disorders Drowsiness	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	2.9% 3/104 • Number of events 5 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
General disorders Fever	6.0% 3/50 • Number of events 5 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	7.7% 8/104 • Number of events 19 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
General disorders Irritability	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	5.8% 6/104 • Number of events 12 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	7.7% 8/104 • Number of events 25 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Ear infection	2.0% 1/50 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.0% 1/50 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Nasopharyngitis	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	8.7% 9/104 • Number of events 18 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Conjunctivitis	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Amoebic dysentery	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Bronchiolitis	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Dengue Fever	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Infections and infestations Urinary tract infection	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Gastrointestinal disorders Diarrhea	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	1.9% 2/104 • Number of events 2 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.
Injury, poisoning and procedural complications Head injury	0.00% 0/50 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.	0.96% 1/104 • Number of events 1 • 3.5 months Safety analyses were performed for solicited and unsolicited AEs by severity using the CTCAE version 4.03 published by NIH in 2010, as well as for SAEs and IMEs.