Phase 2
Completed N=2,499
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
Vaccines · Meningococcal Vaccines
Source: ClinicalTrials.gov NCT01461993 ↗
Enrolled (actual)
2,499
Serious AEs
1.3%
Results posted
Nov 2014
Primary outcomePrimary: Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens — 451.8; 550.3; 892.9; 1084.3 titer
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens |
451.8; 550.3; 892.9; 1084.3; 3695.4; 4763.4 | — |
| PRIMARY Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] |
53.3; 57.8; 25.8; 28.0 | — |
| PRIMARY Percentage of Participants With at Least One Adverse Event (AE) |
43.9; 41.7; 49.5 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV) |
99.4; 99.3; 99.6; 99.5; 99.6; 99.5 | — |
| SECONDARY Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants |
1.4; 2.1; 1.5; 1.4; 1.6; 2.4 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) |
13.7; 16.4; 83.0; 85.8; 94.0; 96.3 | — |
| SECONDARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level |
15.2; 18.8; 14.2; 17.4; 9.4; 10.6 | — |
| SECONDARY Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT) |
9.6; 9.9; 31.9; 33.7; 5.0; 5.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01461993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.