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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: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.
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 |
What the finished NCT01266850 record still lists
NCT01266850 is an interventional study that assigns participants to a tested intervention. Its 1,384 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (167% higher).
The record links to 0 conditions, and to 2 interventions - of which Rotarix® is the first listed.
NCT01266850 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266850's enrollment target sits among peer trials
1,384 55th of 2000 higher than 1,946 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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