Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation

Launched by PATH · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to protect infants from poliomyelitis, a serious viral infection. Researchers want to see how safe and effective it is to give two different oral vaccines (called nOPV1 and nOPV2) together, compared to giving them one at a time. The goal is to find out if giving both vaccines together is just as good as giving each one separately, and to ensure that infants tolerate the combined vaccines well.

To be eligible for this trial, infants must be healthy, between 16 weeks and 23 weeks old, and have received their routine vaccinations, including a polio vaccine earlier in life. Parents must also agree to follow the study's guidelines and attend all required visits. Participants can expect to receive vaccinations and regular health check-ups throughout the study. It’s important to know that infants living with unvaccinated children or those who have recently received certain vaccines may not qualify for this study. Overall, the trial aims to help improve vaccination methods to better protect children against polio.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male or female infant 16 weeks (+ 7 days) of age, at the time of first study vaccination. Healthy as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment by the investigator.
• • 2. Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
• • 3. Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form (ICF) and assessment by the investigator).
• • 4. Prior to study vaccination has received EPI vaccines as per the study EPI schedule and has received a single dose of IPV at 6 weeks (+7 days) of age.
• • 5. Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.
• • 6. Parent agrees for participant to receive routine infant and childhood immunizations as per the approved protocol-adjusted schedule.
• Exclusion Criteria:
• • 1. Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete age appropriate vaccination status (as per local guidelines) with respect to poliovirus vaccines at the time of study vaccine administration.
• • 2. Member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Participants from household where a member received investigational nOPV3 vaccine will also be excluded from the study.
• • 3. Low birth weight (LBW), defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth.
• • 4. Premature birth (less than 37 weeks gestation).
• • 5. From multiple births (due to increased risk of OPV transmissions between siblings).
• • 6. Moderate or severe (grade ≥ 2) acute illness at the time of eligibility/first study vaccination - temporary exclusion. Note: Participants with mild (grade 1) acute illnesses may be considered eligible at the discretion of the investigator.
• • 7. Presence of fever on the day of randomization/first study vaccination (axillary temperature ≥37.5˚C) - temporary exclusion.
• • 8. Presence of abnormal vital signs (respiratory rate and/or heart rate) for age on the day of randomization/first study vaccination - temporary exclusion.
• • 9. A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
• • 10. Any reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member. Topical and inhaled steroids are permitted.
• • 11. Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study of study participants or a household member. Topical and inhaled steroids are permitted.
• • 12. Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
• • 13. Presence of severe malnutrition (weight-for- length/height z-score \<-3SD median \[per WHO published child growth standards\]) - temporary exclusion if marginal and subsequently gains sufficient weight to attain z-score ≥-3 SD.
• • 14. Receipt of any investigational product prior to the first administration of study vaccine, or planned use during the study period.
• • 15. Receipt of rotavirus vaccine within 2 weeks prior to first study vaccination.
• • 16. Prior receipt of an investigational product containing poliovirus vaccine.
• • 17. Receipt of transfusion of any blood product or immunoglobulins prior to the first administration of study vaccine or planned use during the study period.
• • 18. Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).