Phase IV Study of Concomitant Administration of the sIPV and HepA

Launched by INSTITUTE OF MEDICAL BIOLOGY, CHINESE ACADEMY OF MEDICAL SCIENCES · Jun 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a combination of two vaccines—one for polio and one for hepatitis A—works when given together to children who are 18 months old. The study will check if the vaccines create enough protection against these diseases and if they are safe to use at the same time. Researchers will observe the children's immune responses 30 days after they receive the vaccines and will also monitor any side effects that may occur shortly after vaccination and up to six months later.

To participate in this study, children must be at least 4 months old and should have received two doses of a specific polio vaccine before joining. It's important that they haven’t received a third polio vaccine yet. Additionally, they need to be in good health and meet other specific criteria. Parents or guardians will need to give permission for their child to take part in the study. Throughout the trial, participants will receive careful monitoring to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age Requirement: Children aged 4 months at the time of enrollment
• • Vaccination Requirement: volunteers have already taken administration 2 doses of sabin-strain-based inactivated poliovirus vaccine (produced by IMBCAMS), and have not yet been injected with the third dose containing poliovirus antigen.
• • Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
• • Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.
• • Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.
• • Birth condition: Full-term birth (37\~42 gestational weeks) and normal birth weight (no less than 2500g).
• • Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.
• Exclusion Criteria:
• • Health Requirement: Volunteers cannot meet health requirements through physical examinations.
• • History of Related Illness: Volunteers have a history of developing Hepatitis A, poliomyelitis, or immunodeficiency.
• • Birth Condition: Volunteers have a history of abnormal labor stage, asphyxia, nervous system damage, or clinically confirmed pathologic jaundice。
• • Allergic History: Volunteers have a history of allergies to any component of the investigational vaccine (e.g., aluminum hydroxide), any history of vaccine allergies, suspected allergies, or any other severe adverse reactions.
• • Vaccine History: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.
• • Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days prior to vaccination with the investigational vaccine.
• • Neurological and Mental Health: Volunteers have a history of seizures, convulsions, cerebral palsy, epilepsy, mental illness, or a family history of such conditions.
• • Health Conditions: Volunteers have known congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions.
• • Coagulation Abnormalities: Volunteers have a history of coagulation disorders (e.g., coagulation factor deficiency, coagulation disorders).
• • Infectious Diseases: Volunteers have infectious diseases that may affect the study, such as human immunodeficiency virus (HIV) infection, hepatitis, and tuberculosis.
• • Special Condition: Volunteers who could not tolerate venipuncture, or had a history of needle and blood sickness.
• • Organ Removal History: Volunteers have a history of organ removal (e.g., thyroid, pancreas, liver, spleen).
• • History of Blood Products: Volunteers have a history of loss of blood, blood transfusion, the use of adjuvant therapies, or immunoglobulin within 3 months prior to vaccination.
• • Immune Therapy: Volunteers have received immune-enhancing or immune-suppressing therapy within the last 3 months (continuous oral or intravenous administration for more than 14 days) prior to vaccination.
• • Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.
• • Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.