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An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526978
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Investigational sIPV Biological: Control IPV Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group

The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.

Intervention: investigational sIPV

 Biological: 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
Active Comparator: Control Group
The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV
 Biological: 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


Outcome Measures
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Primary Outcome Measures :
  1. The seroconversion rates (SCRs) of each group after primary immunization. [ Time Frame: 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 Outcome Measures :
  1. The incidences of solicited adverse events (AEs) of each group. [ Time Frame: 7 days ]
    Solicited AEs occurred within 7 days after each injection will be collected.

  2. The incidences of unsolicited adverse events (AEs) of each group. [ Time Frame: 30 days ]
    Unsolicited AEs occurred within 30 days after each injection will be collected.

  3. The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group. [ Time Frame: 90-420 days. ]
    SAEs during the period of safety monitoring will be collected.

  4. The post-immune antibody positive rate of each group after primary immunization. [ Time Frame: 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).

  5. The post-immune geometric mean titer (GMT) of each group after primary immunization. [ Time Frame: 90 days. ]
    GMT of each group after primary immunization which lasts 60 days.

  6. The geometric mean fold increase (GMI) of each group after primary immunization. [ Time Frame: 90 days ]
    The GMI is the increase of post-immune GMT from pre-immune GMT.

  7. The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization. [ Time Frame: 90 days ]
    Percentage of subjects with antibody ≥ 1:64 of each group after three-dose

  8. The antibody positive rate of each group before booster dose. [ Time Frame: 420 days ]
    Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. A booster dose at the age of 18months.

  9. The geometric mean titer (GMT) of each group before booster dose. [ Time Frame: 420 days. ]
    GMT of each group before booster dose which occurred at the age of 18months.

  10. The geometric mean fold increase (GMI) of each group before booster dose. [ Time Frame: 420 days ]
    The GMI is the increase of post-immune GMT from pre-i mmune GMT.

  11. The percentage of subjects with antibody ≥ 1:64 of each group before booster dose. [ Time Frame: 420 days ]
    Percentage of subjects with antibody ≥ 1:64 of each group before booster dose which occurred at the age of 18months.

  12. The post-immune antibody positive rate of each group after booster dose. [ Time Frame: 570 days ]

    Subjects whose post-immune antibody level ≥ 1:8 are co

    nsidered antibody positive


  13. The post-immune geometric mean titer (GMT) of each group after booster dose. [ Time Frame: 570 days ]
    GMT of each group after booster dose. The booster dose at the age of 18months

  14. The geometric mean fold increase (GMI) of each group after booster dose. [ Time Frame: 570 days ]
    The GMI is the increase of post-immune GMT from pre-immune GMT.

  15. The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose. [ Time Frame: 570 days ]
    Percentage of subjecs with antibody ≥ 1:64 of each group after booster dose which occurred at the age of 18months.


Eligibility Criteria
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Ages Eligible for Study:   60 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526978


Locations
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China, Jiangsu
Pizhou County Center for Disease Control and Prevention
Pizhou, Jiangsu, China, 221300
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Yuemei Hu Jiangsu Provincial Center for Disease Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03526978    
Other Study ID Numbers: PRO-sIPV-3001
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinovac Biotech Co., Ltd:
Sabin strain
Inactivated poliovirus vaccine
poliomyelitis
 safety
immunogenicity
infant
Additional relevant MeSH terms:
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Poliomyelitis
Myelitis
Central Nervous System Infections
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases