Phase 4
Completed N=100
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Source: ClinicalTrials.gov NCT02582255 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Dec 2019
Primary outcomePrimary: SAEs and Severe AEs — 0; 0 Participants — p=0.05
◆ Published Evidence
Emerging
19citations · ~4 / year
A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania.
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.
Linked Publications
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A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania.
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 |
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) and the linked publication. 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. Informational only — not medical advice.