UnknownPhase 3

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

Bangladesh579 participantsStarted 2018-07-01

Plain-language 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.

Who can participate

Age range1 Year – 3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Apparently healthy children aged 1 to 3 years of age. Family able to understand and comply with planned study procedures and consents to be in the study. * Have received either no dose or only one dose of OPV ( 0 - 1 dose) and has not received any dose of IPV or OCV at any time before enrollment based upon immunization card record or history from parents. Exclusion Criteria: * Parents and children who are unable / unwilling to participate in the full length of the study for any reason. * Child / family planning on moving away from the study area during the study period * A diagnosis, suspicion of, or clinical condition consistent with an immunodeficiency disorder (either in the child or in a member of the immediate family) or is on long-term (\>3 months) of immunosuppressive therapy. * A suspicion or known history of bleeding disorder that would contraindicate venipuncture. * Acute diarrhea, infection or illness at the time of the first visit that would require the child's admission to a hospital or would contraindicate provision of OPV per country guidelines. * History of severe allergic reaction to component of study vaccine * Acute vomiting or diarrhea within 24 hours before the first visit. * Severely malnourished children (Weight-for-age with z-score \< - 3 below the median of the WHO child growth standards.) * Previously received 3 doses of OPV or single dose of IPV or OCV at any time before enrollment based upon immunization card record.

What they're measuring

Anti-poliovirus antibodies

Timeframe: One year

Vibriocidal antibody response

Timeframe: One year

Trial details

NCT IDNCT03581734

SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-25

Contact for this trial

Dr. Firdausi Qadri, PhD

029827001-10 fqadri@icddrb.org