Study of Concomitant Administration of the sIPV and DTaP or MMR
NCT ID: NCT06920069
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
2640 participants
INTERVENTIONAL
2025-05-15
2031-06-15
Brief Summary
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Detailed Description
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For immunogenicity assessment, blood samples on Day 0 and Day 30 after basic immunization of each kind of investigational vaccine would be collected to evaluate the type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies for different groups.
For safety assessment, adverse events after each dose would be recorded through the diary and contact cards by participants' guardians to collect solicited or unsolicited AEs in periods of solicitation and nonsolicitation, respectively. From 31 days after the final dose to 6 months later, serious adverse events will be evaluated by the investigator via phone call or active reports by participants' guardians.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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sIPV + DTaP (concomitant vaccination cohort)
sIPV at 2,3,4 and 18 months of age, DTaP at 2,4,6 and 18 months of age
sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
sIPV/bOPV + DTaP (concomitant vaccination cohort)
sIPV at 2,3 months of age and bOPV at 4 months and 4 years of age DTaP at 2, 4, 6 and 18 months of age
sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3
Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
sIPV + DTaP + MMR (systematic interval-based vaccination cohort)
sIPV at 2,3,4 and 18 months of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV MMR at 18 months of age, randomly assigned in the concomitant administration with sIPV or 1 month after the administration of DTaP
sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
MMR Vaccine
Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose
sIPV/bOPV + DTaP (Systematic interval-based vaccination cohort)
sIPV at 2,3 months of age, bOPV at 4 months and 4 years of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV
sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3
Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
Interventions
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sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3
Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
MMR Vaccine
Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Months
2 Months
ALL
Yes
Sponsors
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Institute of Medical Biology, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Yan Zheng
Role: PRINCIPAL_INVESTIGATOR
Yunnan Provical Center for Disease Control and Prevention
Locations
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Lufeng Center for Disease Control and Prevenion
Chuxiong, Yunnan, China
Yuanmou Center for Disease Control and Prevention
Chuxiong, Yunnan, China
Wuding Center for Disease Control and Prevention
Chuxiong, Yunnan, China
Yaoan Center for Disease Control and Prevention
Chuxiong, Yunnan, China
Lancang Center for Disease Control and Prevention
Puer, Yunnan, China
Yanshan Center for Disease Control and Prevention
Wenshan, Yunnan, China
Qiubei Center for Disease Control and Prevention
Wenshan, Yunnan, China
Guangnan Center for Disease Control and Prevention
Wenshan, Yunnan, China
Mile Center for Disease Control and Prevention
Yisa, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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sIPV-401
Identifier Type: -
Identifier Source: org_study_id
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