Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
- Conditions
- Poliomyelitis
- Interventions
- Biological: Single-dose regimen of medium dosage investigational sIPVBiological: Three-dose regimen of high dosage investigational sIPVBiological: Single-dose regimen of high dosage investigational sIPVBiological: Three-dose regimen of medium dosage investigational sIPVBiological: Three-dose regimen of commercialized IPVBiological: Three-dose regimen of low dosage investigational sIPVBiological: Three-dose regimen of commercialized sIPV
- Registration Number
- NCT02985320
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
- Detailed Description
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
- Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
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Breast feeding, pregnant, or expected to conceive in the next 60 days;
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History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
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Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
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Autoimmune disease or immunodeficiency/immunosuppressive;
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serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
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severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
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History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
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Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
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Long term history of alcoholism or drug abuse;
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Receipt of any of the following products:
- Any subunit or inactivated vaccine within the past 7 day;
- Any live attenuated vaccine within the past 14 days;
- Any other investigational medicine(s) within the past 30 days;
- Any blood product within the past 3 months;
- Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
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Acute illness or acute exacerbation of chronic disease within the past 7 days;
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Axillary temperature > 37.0 °C;
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Infant participants with prior vaccination of poliovirus;
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Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase I Adult Group - Medium dosage Single-dose regimen of medium dosage investigational sIPV * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV PhaseⅡExperimental Group - High dosage Three-dose regimen of high dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV Phase I Adult Group - High dosage Single-dose regimen of high dosage investigational sIPV * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV Phase I Child Group - High dosage Single-dose regimen of high dosage investigational sIPV * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV Phase I Child Group - Medium dosage Single-dose regimen of medium dosage investigational sIPV * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV PhaseⅡExperimental Group - Medium dosage Three-dose regimen of medium dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV PhaseⅡ Control Group -commercialized IPV Three-dose regimen of commercialized IPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of commercialized IPV Phase I Infant Group - Medium dosage Three-dose regimen of medium dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV Phase I Infant Group - Low dosage Three-dose regimen of low dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV Phase I Infant Group - High dosage Three-dose regimen of high dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV PhaseⅡExperimental Group - Low dosage Three-dose regimen of low dosage investigational sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV PhaseⅡControl Group -commercialized sIPV Three-dose regimen of commercialized sIPV * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention:Three-dose regimen of commercialized sIPV
- Primary Outcome Measures
Name Time Method The geometric mean fold increase (GMI) of each group after three-dose regimen 90 days The GMI is the increase of post-immune GMT from pre-immune GMT.
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen 90 days Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen 90 days GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
- Secondary Outcome Measures
Name Time Method The incidences of solicited adverse events (AEs) of each group in both phase I and II trials 7 days Solicited AEs occurred within 7 days after each injection will be collected.
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials 30 days SAEs occurred within 30 days after each injection will be collected.
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials 30 days Unsolicited AEs occurred within 30 days after each injection will be collected.
Trial Locations
- Locations (1)
Pizhou City Center for Disease Control and Prevention
🇨🇳Xuzhou, Jiangsu, China