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
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| ClinicalTrials.gov Identifier: NCT01461993 |
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Recruitment Status :
Completed
First Posted : October 28, 2011
Results First Posted : November 26, 2014
Last Update Posted : December 19, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vaccines Meningococcal Vaccines | Biological: rLP2086 and Gardasil Biological: rLP2086 Biological: Gardasil | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2499 participants |
| Allocation: | Randomized |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Actual Study Start Date : | September 28, 2011 |
| Actual Primary Completion Date : | July 6, 2013 |
| Actual Study Completion Date : | July 6, 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group 1
rLP2086 + Gardasil
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Biological: rLP2086 and Gardasil
Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6. |
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Placebo Comparator: Group 2
rLP2086 and saline
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Biological: rLP2086
Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6. |
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Active Comparator: Group 3
Saline + Gardasil
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Biological: Gardasil
Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6. |
Primary Outcome Measures :
- Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens [ Time Frame: 1 month after Vaccination 3 ]
- Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] [ Time Frame: 1 month after Vaccination 3 ]
- Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ]
Secondary Outcome Measures :
- Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV) [ Time Frame: 1 month after Vaccination 3 ]
- Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants [ Time Frame: Before vaccination 1 ]
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) [ Time Frame: Before vaccination 1, 1 month after vaccination (Vac) 2, 3 ]
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level [ Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3 ]
- Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT) [ Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461993
Locations
Show 87 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01461993 |
| Other Study ID Numbers: |
B1971011 6108A1-2007 ( Other Identifier: Alias Study Number ) |
| First Posted: | October 28, 2011 Key Record Dates |
| Results First Posted: | November 26, 2014 |
| Last Update Posted: | December 19, 2018 |
| Last Verified: | November 2018 |
Keywords provided by Pfizer:
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vaccine rLP2086 Gardasil HPV meningitis B |
N. meningitidis serogroup B adolescents single-blind Meningococcal Vaccines |