Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation (NCT06895486) | Clinical Trial Compass
RecruitingPhase 2
Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
Panama675 participantsStarted 2025-11-11
Plain-language summary
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.
Who can participate
Age range6 Weeks – 7 Weeks
SexALL
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Inclusion 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 medical history, physical examination, and clinical assessment by the investigator.
✓. 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.
Exclusion criteria
✕. 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.
✕. 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.
What they're measuring
1
Frequency of serious adverse events (SAEs)
Timeframe: From time of Dose 1 to end of study at Day 113
2
Frequency of solicited adverse events (AEs)
Timeframe: From time of vaccination until 7 days after Dose 1 (Day 8), Dose 2 (Day 36), and Dose 3 (Day 57)
3
Frequency of unsolicited AEs
Timeframe: From time of vaccination to 28 days after Dose 1 (Day 29), Dose 2 (Day 57), and Dose 3 (Day 85)
4
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum neutralizing antibody (NAb)
Timeframe: 28 days after Dose 2 (Day 57)
5
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum NAb
✕. 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 of the investigator.
✕. 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.