Status:
NOT_YET_RECRUITING
Study of Concomitant Administration of the sIPV and DTaP or MMR
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Conditions:
Polio
Diphteria, Tetanus and Pertussis
Eligibility:
All Genders
2-2 years
Phase:
PHASE4
Brief Summary
This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immun...
Detailed Description
This is a randomized, open-labeled, parallel phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR. 2640 participants aged 2 months wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2031
Estimated Enrollment :
2640 Patients enrolled
Trial Details
Trial ID
NCT06920069
Start Date
May 15 2025
End Date
June 15 2031
Last Update
April 17 2025
Active Locations (9)
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1
Lufeng Center for Disease Control and Prevenion
Chuxiong, Yunnan, China, 651299
2
Yuanmou Center for Disease Control and Prevention
Chuxiong, Yunnan, China, 651300
3
Wuding Center for Disease Control and Prevention
Chuxiong, Yunnan, China, 651600
4
Yaoan Center for Disease Control and Prevention
Chuxiong, Yunnan, China, 675300