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Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

NCT03581734 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 579

Last updated 2022-03-31

No results posted yet for this study

Summary

Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available whole-cell killed Oral Cholera Vaccine (OCVs) with other oral vaccines, specifically, oral polio vaccines (OPV) is lacking. Although the risk of immunological interference due to co-administration of live vaccines with non-live vaccines is considered small if at all, a theoretical concern of interference has been raised. Given the substantial geographic correlation between polio- and cholera-affected and at-risk areas, which include some of the world's most impoverished and hard-to-reach populations, a strategy of co-administration of OCV with OPV to children targeted to receive OPVs has the potential to optimize the use of limited resources and improve coverage for both vaccines. The manufacturer recommendation for a two-week interval between administration of OPV and OCV precludes an integrated campaign or routine use in which OCV could be co-administered with OPV.

Conditions

  • Vaccine Reaction

Interventions

BIOLOGICAL

Oral Polio Vaccine

OPV is a mixture of live attenuated poliovirus strains of each of the three serotypes, selected by their ability to mimic the immune response following infection with wild polioviruses, but with a significantly reduced incidence of spreading to the central nervous system.

BIOLOGICAL

Oral Cholera Vaccine

Bivalent, Killed, Whole Cell Oral Cholera Vaccine

Sponsors & Collaborators

Principal Investigators

  • Dr. Firdausi Qadri, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2022-10-25
Completion
2022-10-25
FDA Drug
Yes

Countries

  • Bangladesh

Study Locations

More Related Trials

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 NCT03581734 on ClinicalTrials.gov