A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine

Last updated: September 25, 2023
Sponsor: Sinovac Biotech Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Sabin Strain Inactivated Poliovirus Vaccine

Clinical Study ID

NCT05850364
PRO-sIPV-4001
  • Ages 42-47
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Thus, this study set up the concomitant vaccination schedule according to the real practice in study area. The primary hypothesis of this study is the seroconversion rate of polio vaccination when administered concomitantly with routine vaccines, is non-inferior to that when administered alone; the secondary hypothesis of this study is the seropositivity rate of diphtheria, tetanus, and pertussis when routine vaccines are administered concomitantly with sIPV, is non-inferior to that administered without sIPV.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has givenwritten informed consent after the study has been explained; 3) Be able to provide thevaccination records after birth; 4) Negative results in SARS-CoV-2 rapid antigen testing,within 24 hours before enrollment; 5) The participant's mother was tested negative for HIV,Syphilis, Hepatitis A, Hepatitis B infection during or before (during pregnancy) herchild's enrollment to this study (the test result should be provided, and that obtainedduring pregnancy is acceptable).

Exclusion

Exclusion Criteria:

  1. History of polio vaccination (except the OPV at birth); 2) Prior vaccination withroutine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae typeb (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previousvaccinations or hypersensitivity to any vaccine component; 4) Infants with premature labor (delivery before week 37 of gestation) and low body weight (birth body weight is <2500 g);
  2. Infants with difficult labor at birth, asphyxiation rescue and history of nervous systeminjury; 6) Congenital malformation or development disorder, genetic defect, severemalnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8)Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cellanemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulationfactor deficiency, blood coagulation disease and blood platelet disorders) or obviousbruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have receivedimmunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surfacecorticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer hasreceived blood products before inoculation of the trial vaccine; 12) The volunteer hasreceived other study drugs within 30 days before inoculation of the trial vaccine; 13) Thevolunteer has received live attenuated vaccines within 14 days before inoculation of thetrial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 daysbefore inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbationof chronic diseases within recent 7 days; 16) Significant acute disease or chronicinfection within the previous 7 days or axillary temperature equal and more than 37.3℃prior to vaccination in the present study; 17) The volunteer has any other factors whichare unsuitable for participation in the clinical trial as judged by the investigators.

Study Design

Total Participants: 1440
Treatment Group(s): 1
Primary Treatment: Sabin Strain Inactivated Poliovirus Vaccine
Phase: 3
Study Start date:
May 22, 2023
Estimated Completion Date:
December 01, 2024

Study Description

This is a multi-country, multi-center, open-labelled, randomized, controlled, extended phase Ⅲ clinical trial. Totally 1440 healthy infants of 6 weeks old (42-47 days) are planned to be enrolled, and then randomized in a 1:1:1:1 ratio into four groups, i.e., co-administration group 1 (group C1), co-administration group 2 (group C2), staggered administration group 1 (group S1) and staggered administration group 2 (group S2). Participants in group C1 and C2 will receive sIPV at 6,10, 14 weeks of age, administered concomitantly with routine infant vaccine (may include DTP-HepB-Hib vaccine, PCV10 or rotavirus vaccine in accordance with the local routine vaccination schedule). Participants in group S1 will receive sIPV at 6,10,14 weeks of age, and receive routine infant vaccines at 8,12,16 weeks of age. Participants in group S2 will receive routine infant vaccines at 6,10,14 weeks of age, and receive sIPV at 8,12, 16 weeks old.

For all the Participants, the immediate reactions within 30 minutes after each dose of vaccination will be observed on site. Guardians of participants will utilize the diary card to record solicited adverse events from the time of vaccination for 7 days post-vaccination of each dose. From the time of the first vaccination and 28 days post-vaccination of the last dose, unsolicited adverse events and any SAEs will be required to recorded in the diary card.

About 3 ml venous blood will be collected before the first vaccination and 28 days (+7) days after the last vaccination of sIPV or routine vaccines. Antibodies level will be determined using the collected sera for immunogenicity evaluation. Group C1 and S1 will be compared in terms of immunogenicity against polio; Group C2 and S2 will be compared in terms of immunogenicity against diphtheria, Tetanus, Pertussis, Hepatitis B, Hib and Pneumococcal.

Connect with a study center

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka, 1000
    Bangladesh

    Active - Recruiting

  • Central Hospital

    Gujranwala,
    Pakistan

    Active - Recruiting

  • The Aga Khan University

    Karachi, 74800
    Pakistan

    Active - Recruiting

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