A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants

Launched by FIDEC CORPORATION · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a new type of polio vaccine, called nOPV2, works in healthy newborns who have already received the standard polio vaccine (IPV). Researchers want to see how much of the poliovirus type-2 can be found in the stool samples of these infants after they receive the nOPV2 vaccine at birth, and then again at later times as they grow. The goal is to better understand the immune response to this new vaccine to help protect against polio.

To be eligible for this study, babies must be less than one week old, born healthy and weighing more than 5.5 pounds. They should not have any serious medical conditions, such as immune system issues or major health problems. Parents or guardians will need to provide written consent for their baby to participate. If you choose to participate, your baby will receive the nOPV2 vaccine at birth and will be closely monitored for their health and immune response over time. This study is not yet recruiting participants, so there will be more information available when it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Newborn infants of maximum 1 week of age with birth weight \> 2,500 g.
• • 2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by medical history and physical examination.
• • 3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
• Exclusion Criteria:
• • 1. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
• • 2. Family history of congenital or hereditary immunodeficiency.
• • 3. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
• • 4. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
• • 5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
• • 6. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• • 7. Acute severe febrile illness on the 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 inclusion criteria are met.).
• • 8. 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.
• • 9. Infants from multiple births or born prematurely (\< 37 weeks of gestation).