Study of Concomitant Administration of the sIPV and DTaP or MMR

Launched by INSTITUTE OF MEDICAL BIOLOGY, CHINESE ACADEMY OF MEDICAL SCIENCES · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how well the sIPV (a polio vaccine) works when given at the same time as the DTaP (which protects against diphtheria, tetanus, and pertussis) or the MMR vaccine (which protects against measles, mumps, and rubella) in infants who are 2 months old. The researchers want to see if giving these vaccines together is safe and effective by checking the babies' immune responses and monitoring any side effects after vaccination.

To be eligible for this trial, infants must be 2 months old, healthy, and born full-term. They should not have received certain vaccines or treatments before joining the study, and must not have any serious health issues. If your baby qualifies and you choose to participate, you will need to sign a consent form to confirm you understand the study. After vaccination, you and your baby will be monitored for any reactions or side effects. This trial is currently not recruiting participants, but it’s important for parents to know that it aims to ensure vaccines can be safely given together, helping to protect infants from serious diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age Requirement: Infants aged 2 months at the time of enrollment
• • 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 at birth (gestational age ≥ 37 weeks and \< 42 weeks) and birth weight ≥ 2500g
• Exclusion Criteria:
• • Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.
• • Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.
• • Recent Vaccination: 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 before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.
• • Allergic History: Volunteers who are allergic to any component of sIPV, bOPV, DTaP, or MMR, or who are allergic to kanamycin sulfate, kanamycin, or gentamicin sulfate, or those with an allergic constitution.
• • Birth Condition: Severe neonatal diseases caused by abnormal delivery and other reasons, such as birth trauma, neonatal asphyxia, respiratory distress syndrome, neonatal intracranial hemorrhage, etc., or patients with clinically confirmed severe hyperbilirubinemia.
• • Neurological and Mental Health: Volunteers with encephalopathy, convulsions, epilepsy, or other progressive neurological disorders, or those whose families have a history of genetic predisposition to convulsions or epilepsy, or a history of genetic predisposition to mental illness.
• • History of Related Illness: Volunteers who have a history of poliomyelitis, pertussis, diphtheria, tetanus, measles, rubella, or mumps.
• • Immune Therapy: Volunteers with immunodeficiency, weakened immune function, or those who have received immunosuppressive therapy (such as long-term systemic glucocorticoid treatment, but excluding local medications like inhalants or nasal sprays).
• • Other Diseases: Volunteers with severe diseases, encompassing those in the cardiovascular system, blood and lymphatic systems, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and bones, etc.
• • 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.