Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine

Fidec

Status and phase: Withdrawn; Phase 3

Conditions: Poliomyelitis

Treatments: Biological: bOPV and nOPV2

Study type: Interventional

Funder types: Other

Identifiers

NCT05166031

nOPV2-001-ABMG

Details and patient eligibility

About

The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.

Sex: All

Ages: 7 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Infants aged 8 weeks (-1, + 2 weeks) with birth weight >2,500 gm.
2. 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 to be in the study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion criteria

1. Infants who have received previous vaccination according to the National Immunization Program (NIP) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b [DTPw-HB-Hib vaccine]).
2. Infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic NIP.
3. 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.
4. Infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (OPV) in the previous 3 months before study vaccine administration.
5. 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.
6. Family history of congenital or hereditary immunodeficiency.
7. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
8. Known allergy to any component of the study vaccines or to any antibiotics, that share molecular composition with the nOPV2 vaccines.
9. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
10. Acute severe febrile illness at 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.).
11. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups

bOPV dose

Active Comparator group

Description:

Naïve infants to receive two doses of bOPV at 2 and 3 months of age.

Treatment:

Biological: bOPV and nOPV2

nOPV2 dose

Active Comparator group

Description:

Naïve infants to receive two doses of nOPV2 at 2 and 3 months of age.

Treatment:

Biological: bOPV and nOPV2

bOPV + nOPV2 dose

Experimental group

Description:

Naïve infants to receive two doses of nOPV2 and bOPV at 2 and 3 months of age.

Treatment:

Biological: bOPV and nOPV2