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New treatment option for Poliomyelitis
Official title Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
ClinicalTrials.gov ID: NCT06895486
What this study is testing
What is Novel Oral Polio Vaccine Type 1 (nOPV1)?
Novel Oral Polio Vaccine Type 1 (nOPV1) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for poliomyelitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 7. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
- 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...
- 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.
- Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.
You likely can't join if
- 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...
- 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...
- 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.
- Premature birth (less than 37 weeks gestation).
- From multiple births (due to increased risk of OPV transmissions between siblings).
- Moderate or severe (grade ≥ 2) acute illness at the time of eligibility/first study vaccination - temporary exclusion. Note: Participants with mild...
See the full eligibility criteria
- 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...
- Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.
- 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).
- 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.
- Prior to study vaccination has received no doses of OPV, based upon no evidence of such vaccination per available documentation.
- Parent agrees for participant to receive routine infant and childhood immunizations as per the approved protocol-adjusted schedule.
- 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...
- 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...
- 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.
- Premature birth (less than 37 weeks gestation).
- From multiple births (due to increased risk of OPV transmissions between siblings).
- 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...
- Presence of fever on the day of randomization/first study vaccination (axillary temperature ≥37.5˚C) - temporary exclusion.
- Presence of abnormal vital signs (respiratory rate and/or heart rate) for age on the day of randomization/first study vaccination - temporary exclusion.
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
- Any reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member. Topical and inhaled steroids are permitted.
- 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.
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
- 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...
- Receipt of any investigational product prior to the first administration of study vaccine, or planned use during the study period.
- Receipt of rotavirus vaccine within 2 weeks prior to first study vaccination.
- Prior receipt of an investigational product containing poliovirus vaccine.
- Receipt of transfusion of any blood product or immunoglobulins prior to the first administration of study vaccine or planned use during the study period.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 weeks to 7 weeks. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.