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Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine
Recruiting
I'm InterestedTrial ID: NCT03581734
Purpose
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.
Official Title
Study on the Immunogenicity of Oral Polio Vaccine (OPV) and Oral Cholera Vaccine (OCV) When Co-administered
Eligibility
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.
Intervention(s):
biological: Oral Polio Vaccine
biological: Oral Cholera Vaccine
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305