Testing a new polio vaccine for infants
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
This study is testing a new polio vaccine for infants to see if it works well when given with other routine vaccinations.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1440 (estimated) |
| Ages | 42 Days to 47 Days |
| Sex | All |
| Sponsor | Sinovac Biotech Co., Ltd Industry-sponsored |
| Locations | 3 sites (Dhaka and 2 other locations) |
| Trial ID | NCT05850364 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the Sabin Inactivated Poliovirus Vaccine (sIPV) when given alongside routine infant vaccinations in healthy infants aged 6 weeks. The study involves 1440 participants who will be randomly assigned to receive either sIPV with routine vaccines or staggered vaccinations. The primary goal is to determine if the immune response to polio vaccination is comparable when administered together with other vaccines. Additionally, the study will monitor any adverse reactions and overall immunogenicity of the vaccines involved.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 6 weeks who have not received prior vaccinations against polio or other routine infant vaccines.
Not a fit: Patients who have a history of severe allergic reactions to vaccines or have received prior vaccinations against the targeted diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance polio vaccination strategies and improve overall immunization rates in infants.
How similar studies have performed: Other studies have shown promising results with similar vaccine co-administration approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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. -
Where this trial is running
Dhaka and 2 other locations
- International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka, Bangladesh (Recruiting)
- Central Hospital — Gujranwala, Pakistan (Recruiting)
- The Aga Khan University — Karachi, Pakistan (Recruiting)
Study contacts
- Principal investigator: Wasif A Khan, Dr. — International Centre for Diarrhoeal Disease Research, Bangladesh
- Study coordinator: Wasif A Khan, Dr.
- Email: wakhan@icddrb.org
- Phone: +88 02 2222 77 001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.