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Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines

NCT06137664 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2025-06-03

No results posted yet for this study

Summary

The main objectives of this study are to :

* evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
* evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
* compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
* evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Novel oral poliomyelitis vaccine type 1 (nOPV1)

Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10\^6.0, or high-dose (HD) 10\^6.5 CCID₅₀/dose

BIOLOGICAL

Novel oral poliomyelitis vaccine type 2 (nOPV2)

Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10\^5.3 and HD 10\^5.6 CCID₅₀/dose.

BIOLOGICAL

Novel oral poliomyelitis vaccine type 3 (nOPV3)

Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10\^6.0, or HD 10\^6.5 CCID₅₀/dose.

BIOLOGICAL

Bivalent Oral Poliomyelitis Vaccine (bOPV)

Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10\^6.0 infective units of type 1 and 10\^5.8 of type 3.

Sponsors & Collaborators

  • Bio Farma, Indonesia

    collaborator UNKNOWN

  • PATH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
0 Days
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2027-12-15
Completion
2027-12-15

Countries

  • Bangladesh

Study Locations

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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 NCT06137664 on ClinicalTrials.gov