A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Public ClinicalTrials.gov record NCT01424644. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®) in Healthy Adolescents When Administered With MenACWY Conjugate Vaccine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01424644
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 801 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 11 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Dec 2012 (Actual)
- Last update posted
- Feb 14, 2014
2011 – 2012
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615 | Birmingham | Alabama | 35205 | — |
| Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A | Fremont | California | 68025 | — |
| Madera Family Medical Group, 1111 W. Fourth Street | Madera | California | 93637 | — |
| Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road | Colorado Springs | Colorado | 80922 | — |
| Dayton Clinical Research, 1100 Salem Ave | Dayton | Florida | 45406 | — |
| Altamonte Pediatric Associates, 101 N. Country Club Rd. #113 | Lake Mary | Florida | 32746 | — |
| Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100 | Marietta | Georgia | 30062 | — |
| Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201 | Council Bluffs | Iowa | 51503 | — |
| Columbia Medical Practice, 5450 Knoll North Drive, Suite 215 | Columbia | Maryland | 21045 | — |
| Roslindale Pediatrics Associates, 1153 Centre Street, Suite 31 | Boston | Massachusetts | 02130 | — |
| Bellevue Family Practice, 2206 Longo Suite 201 | Bellevue | Nebraska | 68005 | — |
| Complete Children's Health, 8201 Northwoods Drive | Lincoln | Nebraska | 68505 | — |
| Meridian Clinical Research, 3319 North, 107th Street | Omaha | Nebraska | 68134 | — |
| Pediatrics and Adolescent Medicine, 120 Stonebridge Parkway, Suite 410 | Woodstock | New York | 30189 | — |
| Capitol Pediatrics and Adolescent Center, 3801 Computer Drive Suite 200 | Raleigh | North Carolina | 27609 | — |
| Ohio Pediatric Research Association, 7371 Brandt Pike Suite C | Huber Heights | Ohio | 45424 | — |
| Omega Medical Research, 400 Bald Hill Road | Warwick | Rhode Island | 02886 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01424644, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2014 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01424644 live on ClinicalTrials.gov.