A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
| Status: | Completed |
|---|---|
| Conditions: | Vaccines |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 11 - 17 |
| Updated: | 12/21/2018 |
| Start Date: | September 28, 2011 |
| End Date: | July 6, 2013 |
A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years
This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil
(human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be
randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection
being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and
saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent
children between the ages of 11 and 17 years old.
(human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be
randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection
being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and
saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent
children between the ages of 11 and 17 years old.
Inclusion Criteria:
- Male or female subjects from 11 to 17 years old at the time of they start the study.
- Subject must be healthy which will be determined by obtaining subject's medical
history, receiving a physical examination and by judgment of the investigator.
Exclusion Criteria:
- Previous vaccination with any meningococcal serogroup B vaccine.
- Previous vaccination with any HPV vaccine.
- Contraindication to vaccination with Gardasil or any HPV vaccine.
We found this trial at
79
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Tulsa, Oklahoma 74127
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Tulsa, Oklahoma 74127
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