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Use of mOPV1 in Routine Immunization in Pakistan.

NCT04504539 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2020-08-07

No results posted yet for this study

Summary

Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for routine immunization. However, type-3 wild poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve eradication of type-1 poliovirus.

The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains live poliovirus, and will eventually lead to complete eradication and containment of type 1 WPV, vaccine-related (VDPV) and Sabin polioviruses. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the proposed responses to type 1 poliovirus outbreaks.

Conditions

  • Oral Polio Vaccine

Interventions

BIOLOGICAL

mOPV

mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1

BIOLOGICAL

bOPV

bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3

BIOLOGICAL

Full dose IPV

FIPV (full dose injectable polio vaccine)

BIOLOGICAL

fractional IPV

fIPV (fractional dose injectable polio vaccine)

Sponsors & Collaborators

Principal Investigators

  • Ali Saleem · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-05-31
Completion
2021-12-31

Countries

  • Pakistan

Study Locations

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Entities

Companies

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 NCT04504539 on ClinicalTrials.gov