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Immunogenicity of Rotavirus Vaccine | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT01199874

Immunogenicity of Rotavirus Vaccine

Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were lice...

Lead sponsor: PATH•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

PATH

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•6 weeks 0 days to 6 weeks 6 days age at the time of enrollment.
•Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
•Written informed consent obtained from the parents or guardians.

Exclusion Criteria

•Hypersensitivity to any of the vaccine components.
•Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
•Use of any immunosuppressive drugs.
•Previous intussusception or abdominal surgery.
•Enrolment in any other trial (Simplified Antibiotic Therapy for Neonatal Sepsis Trial, Management of Omphalitis Trial).
•Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
•Immunoglobulin and/or blood products use since birth or during the study period.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 30, 2013Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment1,140

Start dateApr 2011

Last updatedAug 30, 2013

Condition

Rotavirus Gastroenteritis

Locations shown

Aga Khan University

Karachi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2013Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions