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
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.
Inclusion Criteria:
Exclusion Criteria:
Moreno Valley, California 92557, United States
Fargo, North Dakota 58103, United States
Tulsa, Oklahoma 74127, United States
Tulsa, Oklahoma 74127, United States
League City, Texas 77573, United States
Charlottesville, Virginia 22911, United States