Safety and Immunogenicity of IPOVAC in Young Children
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis
Eligibility Criteria
Inclusion Criteria:
- Children of both sexes, 2 months of ages
- Full term babies (>=37 weeks)
- Weight at birth (>=2500gr)
- Have not been vaccinated with polio vaccine or vaccine containing poliovirus components
- Not currently have acute infection (assessed via clinical check up and asking parents/care givers about health history before enrolment
- Parents/legal guardians agree to participate their children in this study and sign the informed consent.
Exclusion Criteria:
- Currently have chronic diseases (cardiovascular, liver and spleen related etc)
- Use (orally or through infection) with corticoid containing drug (>1mg/kg dose)
- Use of immunocompromised treatment within 4 weeks of enrolment
- Being immunocompromised and autoimmune diseases (HIV, lupus)
- the history of immunocompromised in the family
- history of high fever
- Allergic for any vaccine component
- Fever (>38oC) within 3 days before vaccination or at enrolment
- Malnourished (3rd level or above)
- Blood disorder
- use of vaccines which have not been licences 7 days before enrolment in this study
Sites / Locations
- Preventive Medicine center
- Phu Tho Preventive Medicine Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
IPOVAC 1.5:5:5
IPOVAC 3:10:10
IPOVAC 6:20:20
IMOVAC-POLIO
IPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
IPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
IPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
IMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval