Phase 4
N=154
A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age
Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT02580201 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: SAEs and AEs G3 — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Polio Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Fidec Corporation
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SAEs and AEs G3 |
0; 0 | — |
| PRIMARY Seroprotection Rate |
93.3; 100; 96.2 | — |
| SECONDARY Neutralizing Antibodies 1 |
10.50; 10.50; 9.83; 10.17; 8.50; 8.83 | — |
| SECONDARY Seroconversion Rate |
32.7; 88.5; 36.7; 98.1; 46.9; 96.2 | — |
| SECONDARY Neutralizing Antibodies 2 |
445.5; 650.8; 681.2; 712.2; 306.3; 352.1 | — |
| SECONDARY Seroprotection Rates |
93.0; 60.6; 100; 60.6; 98; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parents or legal guardians as per Dominican Republic regulations.
Exclusion Criteria
- 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
- Group 2: Infants with birth weight (BW) < 2,500 gm.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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).
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02580201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.