- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03526978
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
22 januari 2019 uppdaterad av: Sinovac Biotech Co., Ltd
A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1200
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Jiangsu
-
Pizhou, Jiangsu, Kina, 221300
- Pizhou County Center for Disease Control and Prevention
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 månad till 2 månader (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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;
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Experimental Group
The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd. Intervention: investigational 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
|
Aktiv komparator: Control Group
The control vaccine was manufactured by Sanofi Pasteur Company.
Intervention: control 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The seroconversion rates (SCRs) of each group after primary immunization.
Tidsram: 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).
|
90 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The incidences of solicited adverse events (AEs) of each group.
Tidsram: 7 days
|
Solicited AEs occurred within 7 days after each injection will be collected.
|
7 days
|
The incidences of unsolicited adverse events (AEs) of each group.
Tidsram: 30 days
|
Unsolicited AEs occurred within 30 days after each injection will be collected.
|
30 days
|
The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.
Tidsram: 90-420 days.
|
SAEs during the period of safety monitoring will be collected.
|
90-420 days.
|
The post-immune antibody positive rate of each group after primary immunization.
Tidsram: 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).
|
90 days
|
The post-immune geometric mean titer (GMT) of each group after primary immunization.
Tidsram: 90 days.
|
GMT of each group after primary immunization which lasts 60 days.
|
90 days.
|
The geometric mean fold increase (GMI) of each group after primary immunization.
Tidsram: 90 days
|
The GMI is the increase of post-immune GMT from pre-immune GMT.
|
90 days
|
The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.
Tidsram: 90 days
|
Percentage of subjects with antibody ≥ 1:64 of each group after three-dose
|
90 days
|
The antibody positive rate of each group before booster dose.
Tidsram: 420 days
|
Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive.
A booster dose at the age of 18months.
|
420 days
|
The geometric mean titer (GMT) of each group before booster dose.
Tidsram: 420 days.
|
GMT of each group before booster dose which occurred at the age of 18months.
|
420 days.
|
The geometric mean fold increase (GMI) of each group before booster dose.
Tidsram: 420 days
|
The GMI is the increase of post-immune GMT from pre-i mmune GMT.
|
420 days
|
The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.
Tidsram: 420 days
|
Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.
|
420 days
|
The post-immune antibody positive rate of each group after booster dose.
Tidsram: 570 days
|
Subjects whose post-immune antibody level ≥ 1:8 are co nsidered antibody positive |
570 days
|
The post-immune geometric mean titer (GMT) of each group after booster dose.
Tidsram: 570 days
|
GMT of each group after booster dose.
The booster dose at the age of 18months
|
570 days
|
The geometric mean fold increase (GMI) of each group after booster dose.
Tidsram: 570 days
|
The GMI is the increase of post-immune GMT from pre-immune GMT.
|
570 days
|
The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.
Tidsram: 570 days
|
Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.
|
570 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 augusti 2017
Primärt slutförande (Faktisk)
18 oktober 2017
Avslutad studie (Faktisk)
18 april 2018
Studieregistreringsdatum
Först inskickad
4 maj 2018
Först inskickad som uppfyllde QC-kriterierna
4 maj 2018
Första postat (Faktisk)
16 maj 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 januari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 januari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO-sIPV-3001
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Investigational sIPV
-
Institute of Medical Biology, Chinese Academy of...Yunnan Center for Disease Control and PreventionAvslutad
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Hubei Provincial Center... och andra samarbetspartnersOkänd
-
Jiangsu Province Centers for Disease Control and...Beijing Minhai Biotechnology Co., LtdAvslutad
-
Sinovac Biotech Co., LtdAvslutad
-
Sinovac Biotech Co., LtdAvslutad
-
China National Biotec Group Company LimitedPeking University; Beijing Institute of Biological Products Co Ltd.; Sichuan... och andra samarbetspartnersOkänd
-
Jiangsu Province Centers for Disease Control and...Beijing Minhai Biotechnology Co., LtdAvslutadPolio och postpoliosyndromKina
-
Sinovac Biotech Co., LtdHar inte rekryterat ännu
-
Johnson & Johnson Vision Care, Inc.AvslutadSynskärpaFörenta staterna
-
Ascensia Diabetes CareAvslutad