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

Launched by SINOVAC BIOTECH CO., LTD · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new vaccine called sIPV, which helps protect against polio, and how it works when given alongside other routine vaccines for infants. The goal is to find out if giving sIPV together with vaccines for diseases like diphtheria, tetanus, and whooping cough is just as effective and safe as giving it alone. The study is taking place in Bangladesh and Pakistan, following the vaccination schedule used in these countries, where infants receive their vaccines at 6, 10, and 14 weeks old.

To participate, infants must be 6 weeks old and have a parent or guardian who can provide written consent. They also need to show that they haven’t had certain vaccinations before. Infants with specific health issues, like severe allergies to vaccines or certain chronic diseases, won’t be eligible to join the trial. For those who do participate, they can expect to receive the sIPV vaccine along with other routine vaccinations and will be monitored for their health and safety throughout the study. This trial is currently recruiting participants, and it's an important step in ensuring that polio vaccines are effective and safe for infants.

Gender

ALL

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).
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• 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.
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