Polio
Conditions
Brief summary
Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life
Interventions
BIOLOGICALb-OPV
BIOLOGICALm-OPV2
BIOLOGICALm-IPV HD
BIOLOGICALt-IPV
Sponsors
Bill and Melinda Gates Foundation
Vaxtrials S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 6 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Age: 6 weeks (-7 to +14 days). 2. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination. 3. Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.
Exclusion criteria
1. Previous vaccination against poliovirus. 2. Low birth weight (BW \<2,500 gm). 3. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection. 4. Family history of congenital or hereditary immunodeficiency. 5. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 6. Known allergy to any component of the study vaccines. 7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 weeks | To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (\ week 21 of life). |
| Efficacy | 4 weeks | To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 (\ 14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and \>4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (\ 18 weeks of age). |
Countries
Panama
Outcome results
None listed