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NCT01424644 · ClinicalTrials.gov registry record · Phase 4
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
A Phase 4 study of Meningococcal Meningitis, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 801
- Enrollment target
- 20
- Study locations
NCT01424644: Completed Phase 4 study of Meningococcal Meningitis, sponsored by Novartis.
NCT01424644 is a Phase 4 study of Meningococcal Meningitis that has completed, run by Novartis. The registered enrollment target is 801 participants, above the 541-participant average among 4 other Meningococcal Meningitis trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01424644, a Phase 4 study of Meningococcal Meningitis, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 801 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.
Primary Outcome
The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.
Conditions Studied
Interventions
- BIOLOGICAL Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
- BIOLOGICAL MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
Study Locations (20)
Nebraska
- Bellevue Family Practice, 2206 Longo Suite 201 - Bellevue
- Complete Children's Health, 8201 Northwoods Drive - Lincoln
- Meridian Clinical Research, 3319 North, 107th Street - Omaha
California
- Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A - Fremont
- Madera Family Medical Group, 1111 W. Fourth Street - Madera
Florida
- Dayton Clinical Research, 1100 Salem Ave - Dayton
- Altamonte Pediatric Associates, 101 N. Country Club Rd. #113 - Lake Mary
Alabama
- Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615 - Birmingham
Colorado
- Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road - Colorado Springs
Georgia
- Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100 - Marietta
Iowa
- Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201 - Council Bluffs
Maryland
- Columbia Medical Practice, 5450 Knoll North Drive, Suite 215 - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 801 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT01424644 record still lists
NCT01424644 is an interventional study that assigns participants to a tested intervention. The registered 801 participants enrollment target is mid-sized for trials with a published cap, above the 541-participant average among 4 other Meningococcal Meningitis trials with a reported enrollment target (48% higher).
The record links to 1 condition, with Meningococcal Meningitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine is the first listed.
NCT01424644 names 20 study sites across 16 states, led by Nebraska, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01424644 about?
NCT01424644 is a clinical study titled "A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents". The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.
What is the current status of trial NCT01424644?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 801 participants. The study started on 2011-09. Estimated completion is 2012-12.
What conditions does trial NCT01424644 study?
This clinical trial studies the following conditions: Meningococcal Meningitis.
What interventions are being tested in trial NCT01424644?
The interventions under investigation include: Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine (BIOLOGICAL), MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01424644?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01424644 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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