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Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV

NCT06114810 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2023-11-07

No results posted yet for this study

Summary

The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:

1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
2. Separation of bOPV and nOPV2 with an interval of 4 weeks.

Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.

Conditions

Interventions

BIOLOGICAL

polio vaccines: nOPV2, bOPV, IPV

Co-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules.

Sponsors & Collaborators

Principal Investigators

  • Dr. K Zaman, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
42 Days
Max Age
48 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-06-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114810 on ClinicalTrials.gov