Poliomyelitis
Conditions
Keywords
Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
Brief summary
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
Detailed description
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
Interventions
BIOLOGICALInvestigational sIPV
Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV
BIOLOGICALControl IPV
Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer between 60-90 days 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 or guardians of the participants 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;
Exclusion criteria
* Prior vaccination with Poliovirus Vaccine; * 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; * Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness; * Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; * Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry; * Blood product prior to study entry; * Any other investigational medicine(s) within 30 days prior to study entry; * Any live attenuated vaccine within 14 days prior to study entry; * Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; * Acute disease or acute stage of chronic disease within 7 days prior to study entry; * Axillary temperature \> 37.0 °C; * Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rates (SCRs) of each group after primary immunization. | 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. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of unsolicited adverse events (AEs) of each group. | 30 days | Unsolicited AEs occurred within 30 days after each injection will be collected. |
| The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group. | 90-420 days. | SAEs during the period of safety monitoring will be collected. |
| The post-immune antibody positive rate of each group after primary immunization. | 90 days | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2). |
| The post-immune geometric mean titer (GMT) of each group after primary immunization. | 90 days. | GMT of each group after primary immunization which lasts 60 days. |
| The geometric mean fold increase (GMI) of each group after primary immunization. | 90 days | The GMI is the increase of post-immune GMT from pre-immune GMT. |
| The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization. | 90 days | Percentage of subjects with antibody ≥ 1:64 of each group after three-dose |
| The antibody positive rate of each group before booster dose. | 420 days | Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months. |
| The incidences of solicited adverse events (AEs) of each group. | 7 days | Solicited AEs occurred within 7 days after each injection will be collected. |
| The geometric mean fold increase (GMI) of each group before booster dose. | 420 days | The GMI is the increase of post-immune GMT from pre-i mmune GMT. |
| The percentage of subjects with antibody ≥ 1:64 of each group before booster dose. | 420 days | Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months. |
| The post-immune antibody positive rate of each group after booster dose. | 570 days | Subjects whose post-immune antibody level ≥ 1:8 are co nsidered antibody positive |
| The post-immune geometric mean titer (GMT) of each group after booster dose. | 570 days | GMT of each group after booster dose. The booster dose at the age of 18months |
| The geometric mean fold increase (GMI) of each group after booster dose. | 570 days | The GMI is the increase of post-immune GMT from pre-immune GMT. |
| The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose. | 570 days | Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months. |
| The geometric mean titer (GMT) of each group before booster dose. | 420 days. | GMT of each group before booster dose which occurred at the age of 18months. |
Countries
China
Outcome results
None listed