Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01461980 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
A Phase 2 study of Vaccines and Meningococcal Vaccines, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,648
- Enrollment target
- 20
- Study locations
NCT01461980 is a Phase 2 study of Vaccines and Meningococcal Vaccines that has completed, run by Pfizer. The registered enrollment target is 2,648 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT01461980, a Phase 2 study of Vaccines and Meningococcal Vaccines, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,648 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
Conditions Studied
Interventions
- BIOLOGICAL rLP2086 + MCV4 + Tdap
- BIOLOGICAL MCV4 + Tdap + saline
- BIOLOGICAL rLP2086 + saline
Study Locations (20)
California
- Kaiser Permanente Fresno - Fresno
- Kaiser Permanente Hayward - Hayward
- Pediatric Care Medical Group - Huntington Beach
- Loma Linda University - Loma Linda
- Loma Linda University Health Care Pediatric Clinic - Loma Linda
- Loma Linda University Medical Center - Loma Linda
- Loma Linda University Health Care - Moreno Valley Pediatrics - Moreno Valley
- Bayview Research Group, LLC - Paramount
- Center for Clinical Trials, LLC - Paramount
- Kaiser Permanente Sacramento - Sacramento
Arizona
- Clinical Research Advantage Inc/ East Valley Family Physicians, PLC - Chandler
- Radiant Research, Inc. - Chandler
- Clinical Research Advantage, Inc./Mesa Family Medical Center, PC - Mesa
- Clinical Research Advantage, Inc./Desert - Mesa
- Radiant Research, Inc. - Tucson
- Radiant Research, Inc. - Tucson
Alabama
- Radiant Research, Inc. - Birmingham
- Costal Clinical Research, Inc. - Daphne
Arkansas
- The Children's Clinic of Jonesboro, PA - Jonesboro
- Arkansas Pediatric Clinic - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,648 participants |
| Start Date | 2011-09-28 |
| Est. Completion | 2014-05-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01461980
The ClinicalTrials.gov registry entry for NCT01461980 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,648 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Vaccines appearing as the primary indexed condition, and to 3 interventions - of which rLP2086 + MCV4 + Tdap is the first listed.
NCT01461980 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01461980 about?
NCT01461980 is a clinical study titled "A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age". This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subject...
What is the current status of trial NCT01461980?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,648 participants. The study started on 2011-09-28. Estimated completion is 2014-05-08.
What conditions does trial NCT01461980 study?
This clinical trial studies the following conditions: Vaccines, Meningococcal Vaccines.
What interventions are being tested in trial NCT01461980?
The interventions under investigation include: rLP2086 + MCV4 + Tdap (BIOLOGICAL), MCV4 + Tdap + saline (BIOLOGICAL), rLP2086 + saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT01461980?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01461980 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.