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

Phase 4

Completed

• Conditions: Poliomyelitis

• Registration Number: NCT02580201
• Lead Sponsor: Fidec Corporation

Brief Summary

The purpose of this study is to assess the safety (serious adverse events \[SAEs\]), and severe adverse events \[AEs\] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.

Detailed Description

This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart (Group 2)

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-08-11
• Results First Submitted: 2020-08-16
• Results First Submitted QC: 2020-08-16
• Results First Posted: 2020-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Age:

   Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group 2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.

2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.

3. Written informed consent obtained from 1 or 2 parents or legal guardians as per Dominican Republic regulations.

Exclusion Criteria

1. Previous Vaccinations:

   Group 1: Previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks.

   Group 2: Any vaccination against poliovirus

2. Group 2: Infants with birth weight (BW) < 2,500 gm.

3. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.

4. Family history of congenital or hereditary immunodeficiency.

5. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).

6. Known allergy to any component of the study vaccines or to any antibiotics.

7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.

8. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met).

10. Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months, or is scheduled to receive OPV during the study period.

11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SAEs and AEs G3	6 months	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.
Seroprotection Rate	3 months	Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).

Secondary Outcome Measures

Name	Time	Method
Neutralizing Antibodies 1	3 months	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).
Seroconversion Rate	3 months	Seroconversion rate of type-specific neutralizing antibodies at Day 28 for Group 1, and at Day 84 for Group 2.
Neutralizing Antibodies 2	3 months	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).
Seroprotection Rates	4 weeks	Seroprotection rates of type-specific neutralizing antibodies at Days 0 and 28 in Group 1 and at Day 0 in Group 2.