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

Primary Purpose

Poliomyelitis, Polio

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sabin Strain Inactivated Poliovirus Vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Polio vaccines, Poliomyelitis Vaccine, Inactivated polio vaccine, Sabin Inactivated Poliovirus Vaccine (sIPV)

Eligibility Criteria

42 Days - 47 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination 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) her child's enrollment to this study (the test result should be provided, and that obtained during pregnancy is acceptable). - Exclusion Criteria: 1) History of polio vaccination (except the OPV at birth); 2) Prior vaccination with routine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previous vaccinations 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); 5) Infants with difficult labor at birth, asphyxiation rescue and history of nervous system injury; 6) Congenital malformation or development disorder, genetic defect, severe malnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8) Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer has received blood products before inoculation of the trial vaccine; 12) The volunteer has received other study drugs within 30 days before inoculation of the trial vaccine; 13) The volunteer has received live attenuated vaccines within 14 days before inoculation of the trial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 days before inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbation of chronic diseases within recent 7 days; 16) Significant acute disease or chronic infection 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 which are unsuitable for participation in the clinical trial as judged by the investigators. -

Sites / Locations

  • International Centre for Diarrhoeal Disease Research, BangladeshRecruiting
  • Central HospitalRecruiting
  • The Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

group C1

group C2

group S1

group S2

Arm Description

Co-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360)

Co-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old

Administration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old

Administration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old

Outcomes

Primary Outcome Measures

To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccination To evaluate the safety in terms of ARs (Vaccine-related AEs
Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination

Secondary Outcome Measures

To evaluate non-inferiority of immune response to diphtheria and tetanus antigens, when routine vaccines are administered concomitantly with sIPV
Seropositivity rate of IgG antibodies against diphtheria and tetanus, at 28 days after vaccination
To evaluate non-inferiority of immune response to acellular pertussis antigens, when routine vaccines are administered concomitantly with sIPV
Seropositivity rate of IgG antibodies against pertussis toxin (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), at 28 days after vaccination
To evaluate the immunogenicity against hepatitis B and Hib, when routine vaccines are administered concomitantly with sIPV
Sero-protection rate of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination and GMC of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination
To evaluate the immunogenicity against pneumococcal, when routine vaccines are administered concomitantly with sIPV
Sero-protection rate of IgG antibodies against pneumococcal, at 28 days after vaccination and GMC of IgG antibodies against pneumococcal, at 28 days after vaccination
To evaluate other immunogenicity of sIPV, when administered concomitantly with routine vaccines
GMT of neutralizing antibodies against polioviruses of three serotypes, at 28 days after three doses of vaccination
To evaluate other immunogenicity against diphtheria, tetanus, acellular pertussis antigens
GMC of IgG antibodies against diphtheria, tetanus, acellular pertussis antigens, at 28 days after vaccination
To evaluate the safety in terms of SAEs
Incidence of SAEs throughout the study

Full Information

First Posted
April 28, 2023
Last Updated
September 25, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05850364
Brief Title
A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine
Official Title
A Multi-country, Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Tolerability of Sabin Strain Inactivated Poliovirus Vaccine Administered With or Without Routine Infant Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Polio
Keywords
Polio vaccines, Poliomyelitis Vaccine, Inactivated polio vaccine, Sabin Inactivated Poliovirus Vaccine (sIPV)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group C1
Arm Type
Experimental
Arm Description
Co-administration of sIPV and routine infant vaccines at 6,10,14 weeks old (N=360)
Arm Title
group C2
Arm Type
Experimental
Arm Description
Co-administration of sIPV and routine infant vaccines at 6, 10,14 weeks old
Arm Title
group S1
Arm Type
Experimental
Arm Description
Administration of sIPV at 6,10,14 weeks old; Administration of routine infant vaccines at 8,12,16 weeks old
Arm Title
group S2
Arm Type
Experimental
Arm Description
Administration of routine infant vaccines at 6,10,14 weeks old; Administration of sIPV at 8,12,16 weeks old
Intervention Type
Biological
Intervention Name(s)
Sabin Strain Inactivated Poliovirus Vaccine
Intervention Description
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 old, 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 old, and receive routine infant vaccines at 8,12,16 weeks old. Participant s in group S2 will receive routine infant vaccines at 6,10,14 weeks old, and receive sIPV at 8,12, 16 weeks old.
Primary Outcome Measure Information:
Title
To evaluate the non-inferiority of immune response to polio vaccination, when administered concomitantly with routine vaccines
Description
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccinationadministered concomitantly with routine vaccines
Time Frame
28 days
Title
Seroconversion rates of neutralizing antibody against polioviruses of three serotypes, at 28 days after three doses of vaccination To evaluate the safety in terms of ARs (Vaccine-related AEs
Description
Incidence of adverse reactions within 7 days after each dose of vaccination Incidence of adverse reactions within 7 days after each dose of vaccination
Time Frame
7 days
Secondary Outcome Measure Information:
Title
To evaluate non-inferiority of immune response to diphtheria and tetanus antigens, when routine vaccines are administered concomitantly with sIPV
Description
Seropositivity rate of IgG antibodies against diphtheria and tetanus, at 28 days after vaccination
Time Frame
28 days
Title
To evaluate non-inferiority of immune response to acellular pertussis antigens, when routine vaccines are administered concomitantly with sIPV
Description
Seropositivity rate of IgG antibodies against pertussis toxin (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), at 28 days after vaccination
Time Frame
28 days
Title
To evaluate the immunogenicity against hepatitis B and Hib, when routine vaccines are administered concomitantly with sIPV
Description
Sero-protection rate of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination and GMC of IgG antibodies against hepatitis B and Hib, at 28 days after vaccination
Time Frame
28 days
Title
To evaluate the immunogenicity against pneumococcal, when routine vaccines are administered concomitantly with sIPV
Description
Sero-protection rate of IgG antibodies against pneumococcal, at 28 days after vaccination and GMC of IgG antibodies against pneumococcal, at 28 days after vaccination
Time Frame
28 days
Title
To evaluate other immunogenicity of sIPV, when administered concomitantly with routine vaccines
Description
GMT of neutralizing antibodies against polioviruses of three serotypes, at 28 days after three doses of vaccination
Time Frame
28 days
Title
To evaluate other immunogenicity against diphtheria, tetanus, acellular pertussis antigens
Description
GMC of IgG antibodies against diphtheria, tetanus, acellular pertussis antigens, at 28 days after vaccination
Time Frame
28 days
Title
To evaluate the safety in terms of SAEs
Description
Incidence of SAEs throughout the study
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
47 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) Infants of 6 weeks old (42-47 days); 2) For whom a parent/legal guardian has given written informed consent after the study has been explained; 3) Be able to provide the vaccination 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) her child's enrollment to this study (the test result should be provided, and that obtained during pregnancy is acceptable). - Exclusion Criteria: 1) History of polio vaccination (except the OPV at birth); 2) Prior vaccination with routine infant vaccines against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b (Hib), Pneumococcal or rotavirus; 3) History of severe allergic reaction after previous vaccinations 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); 5) Infants with difficult labor at birth, asphyxiation rescue and history of nervous system injury; 6) Congenital malformation or development disorder, genetic defect, severe malnutrition, etc.; 7) Autoimmune disease or immunodeficiency/immunosuppression; 8) Patients with serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders); 9) Abnormal coagulation functions (such as coagulation factor deficiency, blood coagulation disease and blood platelet disorders) or obvious bruise or blood coagulation disorders diagnosed by the doctors; 10) Those who have received immunosuppressant therapy, cytotoxic drug therapy and inhaled corticosteroid therapy (excluding the corticosteroid aerosol therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 11) The volunteer has received blood products before inoculation of the trial vaccine; 12) The volunteer has received other study drugs within 30 days before inoculation of the trial vaccine; 13) The volunteer has received live attenuated vaccines within 14 days before inoculation of the trial vaccine; 14) The volunteer has received subunit or inactivated vaccines within 7 days before inoculation of the trial vaccine; 15) Various acute diseases or acute exacerbation of chronic diseases within recent 7 days; 16) Significant acute disease or chronic infection 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 which are unsuitable for participation in the clinical trial as judged by the investigators. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wasif A Khan, Dr.
Phone
+88 02 2222 77 001
Ext
2348
Email
wakhan@icddrb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wasif A Khan, Dr.
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wasif A Khan
Phone
02222277001
Email
wakhan@icddrb.org
Facility Name
Central Hospital
City
Gujranwala
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salman Athar, Dr.
Email
doctorsalmanathar@gmail.com
Facility Name
The Aga Khan University
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali F Saleem, Dr.
Email
ali.saleem@aku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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