Phase 3
N=905
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT05033561 ↗Enrolled (actual)
905
Serious AEs
2.7%
Results posted
Aug 2024
Primary outcome: Primary: Seroconversion Rate at 1, 2 & 4 Weeks Interval — 253; 269; 277 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nOPV2 (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Fidec Corporation
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate at 1, 2 & 4 Weeks Interval |
253; 269; 277 | 0.05 |
| SECONDARY Neutralizing Antibodies at 1, 2 & 4 Week Interval |
10.7; 11.5; 10.2; 1232.3; 1726.3; 2327.6 | 0.05 |
| SECONDARY Serious Adverse Events (SAEs) and Important Medical Events (IMEs) |
0; 0; 1; 8; 7; 9 | — |
| SECONDARY Solicited Adverse Events (AEs) |
84; 90; 83; 44; 50; 40 | — |
| SECONDARY Unsolicited Adverse Events (AEs) |
13; 10; 11; 9; 10; 14 | — |
Summary
Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants
Eligibility Criteria
Inclusion Criteria
- Infants aged 6 to 8 weeks with birth weight > 2,500 g.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.
Exclusion Criteria
- Infants who have received previous vaccination against poliomyelitis.
- Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP).
- Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
- Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
- Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
- Infants from multiple births or born prematurely (< 37 weeks of gestation)
Data sourced from ClinicalTrials.gov (NCT05033561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.