Vaccine Supply, Delays and Shortages |
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Clinical Trial: Consistency Lots Vaccine Study
This study is no longer recruiting patients.
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Purpose
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Rotavirus Infections | Vaccine: Investigational Vaccine | Phase II Phase III |
MedlinePlus related topics: Rotavirus Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Eligibility
Ages Eligible for Study: 6 Weeks - 12 Weeks, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Healthy infants
Exclusion Criteria:
- History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- Known or suspected problems with the immune system
- Fever at time of immunization
- Prior administration of a rotavirus vaccine
- History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: September 22, 2004
ClinicalTrials.gov Identifier: NCT00092456
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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