Phase 4
N=100
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT02582255 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Dec 2019
Primary outcome: Primary: SAEs and Severe AEs — 0; 0 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sabin mOPV2 (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Fidec Corporation
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SAEs and Severe AEs |
0; 0 | 0.05 |
| PRIMARY Seroprotection Rate of Type 2 Polio Neutralizing Antibodies. |
50; 47 | 0.025 sig |
| SECONDARY Seroprotection Rate for Type 2 Polio Neutralizing Antibodies. |
47 | 0.025 sig |
| SECONDARY Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs). |
6; 9 | 0.05 |
Summary
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
Eligibility Criteria
Inclusion Criteria
- 1 to 5 years of age, previously vaccinated with three or four doses of IPV.
- Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.
Exclusion Criteria
- Previous vaccination against poliovirus outside the national immunization schedule.
- 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.
- 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.
- 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 (NCT02582255). 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.