evaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease) MedDRA version: 18.0 Level: LLT Classification code 10036016 Term: Poliomyelitis NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Polio Sabin TM Mono Two (oral)
Monovalent Oral Poliomyelitis vaccine Type 2 (mOPV2)
Product Name: SABIN monovalent Oral Polio Vaccine type 2
Product Code: mOPV2
Pharmaceutical Form: Oral
Sponsors
FIDEC - Fighting Infectious Diseases in Emerging Countries
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 1 to 5 years of age, previously vaccinated with three or four doses of IPV. 2. Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination. 3. Written informed consent obtained from 2 parents or legal guardian(s) as per country regulations Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Previous vaccination against poliovirus outside the national immunization schedule. 2. Polio vaccines including polio combined vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented). 3. Any vaccine in the previous 4 weeks. 4. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection. 5. Family history of congenital or hereditary immunodeficiency. 6. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 7. Known allergy to any component of the study vaccines or to any antibiotics. 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to assess the safety (serious adverse events [SAEs] and severe adverse events [AEs] grade 3 according to CTCAE 4.03) and immunogenicity (seroprotection rate) of one dose of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.;Secondary Objective: Secondary objectives are to assess: - The safety (mild and moderate solicited and unsolicited AEs, Important Medical Events [IMEs], and laboratory assessments) of one or two doses SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years - The safety (serious adverse events [SAEs] and severe adverse events [grade 3 AEs according to CTCAE 4.03]) of two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years - The immunogenicity (seroprotection rate) of two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years - The immunogenicity (seroconversion rate, median and geometric mean antibody titers) of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years - The baseline seroprotection rates against all 3 polio types at Day 0 ;Primary end point(s): The following endpoints will be evaluated by group and overall: - Safety: incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in both groups. - Immunogenicity: seroprotection rate of type 2 polio neutralizing antibodies at Day 28 following the first dose of SABIN mOPV2 in both groups. (Seroprotection is defined as type 2-specific antibody titers =1:8 and seroprotection rate as the percentage of seroprotected subjects per group.) ;Timepoint(s) of evaluation of this end point: - Safety: will be evaluated throughout the study period - Immunogenicity: will be evaluated at day 28 following the first dose of mOPV2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following safety and immunogenicity endpoints will be evaluated by group and overall. Safety: - Incidence of any SAEs, any AEs grade 3, and any IMEs throughout the study period. (The following will be considered IMEs: medically significant events that do not meet any of the SAE criteria but may require medical or surgical consultation or intervention to prevent one of the other serious outcomes listed in the SAE definition.) - Incidence of any mild and moderate solicited AEs for 7 days after the first dose in both groups and for 7 days after the second dose in Group 2; - Incidence of any mild and moderate unsolicited AEs throughout the study period; - Incidence and description of deviations from normal of safety chemistry at Day 0 (both groups), 7 and 28 days after the first dose in Groups 1 and 2 and at 7 and 28 days after the second dose in Group 2. Immunogenicity: - Seroprotection rate at day 28 after the second dose of SABIN mOPV2 in Group 2. - The baseline seroprotection rates against all 3 polio types at Day 0 - Median and geometric mean antibody titers of type 2 polio neutralizing antibody titers at day 0, day 28 after dose 1, and day 28 after dose 2 (group 2). - Seroconversion rate of type 2 polio neutralizing antibodies at 28 days after the first dose in Groups 1 and 2 and at 28 days after the second dose in Group 2. (Seroconversion is defined as a change from seronegative to seropositive and antibody titers of =1:8, and in seropositive subjects, an antibody titer increase of =4 fold over baseline titers). ;Timepoint(s) of evaluation of this end point: - Incidence of any SAEs, any AEs grade 3, any IMEs, mild and moderate unsolicited AEs throughout the study period. - Incidence of any mild and moderate solicited AEs for 7 days after the first dose in both groups and for 7 days after the second dose in Group 2 - deviations from normal of safety chemistry at Day 0 (both groups), 7 and 28 days after the first | — |
Countries
Lithuania
Contacts
Public ContactClinic of Children Diseases
Vilnius University, Santariskiu Clinic
Outcome results
None listed