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NCT01266850 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 1,384
- Enrollment target
NCT01266850 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,384 participants.
The verdict
NCT01266850, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,384 participants
- Enrollment target
Study Summary
Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.
Interventions
- BIOLOGICAL Rotarix®
- BIOLOGICAL RotaTeq®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,384 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01266850
The ClinicalTrials.gov registry entry for NCT01266850 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rotarix® is the first listed.
NCT01266850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01266850 about?
NCT01266850 is a clinical study titled "Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules". Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that t...
What is the current status of trial NCT01266850?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,384 participants. The study started on 2011-03. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01266850?
The interventions under investigation include: Rotarix® (BIOLOGICAL), RotaTeq® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01266850?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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