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

NCT05166031 | Withdrawn Phase 3 DMC

• 1 other identifier: nOPV2-001-ABMG
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• Seroconversion rate

  Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV

  2 months

• Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs)

  Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV

  6 months

Secondary Outcomes (7)

• Immunogenicity to poliovirus type 2

  2 months

• Immunogenicity to poliovirus type 2

  2 months

• Immunogenicity to poliovirus type 2

  2 months

• Assessment and comparison of immunogenicity to poliovirus type 1 and 3

  2 months

• Assessment and comparison of immunogenicity to poliovirus type 1 and 3

  2 months

Study Arms (3)

bOPV dose

ACTIVE COMPARATOR

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

Biological: bOPV and nOPV2

nOPV2 dose

ACTIVE COMPARATOR

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

Biological: bOPV and nOPV2

bOPV + nOPV2 dose

EXPERIMENTAL

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

Biological: bOPV and nOPV2

Interventions

bOPV and nOPV2 BIOLOGICAL

Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.

bOPV + nOPV2 dose; bOPV dose; nOPV2 dose

Eligibility Criteria

• Age: 7 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 8 weeks (-1, + 2 weeks) with birth weight \>2,500 gm.
• 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.
• Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

You may not qualify if:

• 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 \[DTPw-HB-Hib vaccine\]).
• 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.
• 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 polio 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 vaccines or to any antibiotics, that share molecular composition with the nOPV2 vaccines.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• 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.

Sponsors & Collaborators

• Fidec Corporation: lead
• Bill and Melinda Gates Foundation: collaborator

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: December 21, 2021
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 18, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-12