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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

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

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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

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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Kliniska prövningar på Investigational sIPV

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