Poliomyelitis
Conditions
Keywords
Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
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.
Interventions
BIOLOGICALSingle-dose regimen of high dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
BIOLOGICALSingle-dose regimen of medium dosage investigational sIPV
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
BIOLOGICALThree-dose regimen of commercialized IPV
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* 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;
Exclusion criteria
* Breast feeding, pregnant, or expected to conceive in the next 60 days; * 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; * Congenital malformation, developmental disorders, genetic defects, or severe malnutrition; * Autoimmune disease or immunodeficiency/immunosuppressive; * serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc; * severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; * History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen; * Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy; * Long term history of alcoholism or drug abuse; * Receipt of any of the following products: 1. Any subunit or inactivated vaccine within the past 7 day; 2. Any live attenuated vaccine within the past 14 days; 3. Any other investigational medicine(s) within the past 30 days; 4. Any blood product within the past 3 months; 5. 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; * Acute illness or acute exacerbation of chronic disease within the past 7 days; * Axillary temperature \> 37.0 °C; * Infant participants with prior vaccination of poliovirus; * Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
China
Outcome results
None listed