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 - Full Text View

Purpose

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	Intervention	Phase
Vaccines Meningococcal Vaccines	Biological: rLP2086 and Gardasil Biological: rLP2086 Biological: Gardasil	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	A Phase 2, Randomized, Active-Controlled, Observer-Blinded Trial, to Assess the Safety, Tolerability, and Immunogenicity of Gardasil (HPV) Vaccine and Bivalent rLP2086 Vaccine When Administered Concomitantly in Healthy Subjects Aged >= 11 to <18 Years

Further study details as provided by Pfizer:

Primary Outcome Measures:

The geometric mean titers (GMTs) of the 4 HPV antigens (HPV 6, HPV 11, HPV 16, and HPV 18) measured at 1 month after the third vaccination (Visit 5) of Gardasil®, among subjects in Groups 1 and 3. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
hSBA geometric mean titers (GMTs) of the 2 primary strains (PMB80 [A22], PMB2948 [B24]), measured at 1-month after the third vaccination (Visit 5) of bivalent rLP2086 vaccine, among subjects in Groups 1 and 2. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
Proportion of subjects reporting local reactions, systemic reactions, antipyretic use after each vaccination [ Time Frame: Month 0, 2, 6 ] [ Designated as safety issue: Yes ]
Proportion of subjects with at least one SAE during the following intervals: 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the followup phase, and throughout the study period. [ Time Frame: Month 1, 3, 7, 12 ] [ Designated as safety issue: Yes ]
Proportion of subjects with at least one AE during the following intervals: 30 days after each vaccination, 30 days after any vaccination, and during the vaccination phase. [ Time Frame: Month 1, 3, 7, ] [ Designated as safety issue: Yes ]
Proportion of subjects reporting at least one immediate adverse event after each vaccination. [ Time Frame: Month 0,2,6 ] [ Designated as safety issue: Yes ]
Proportion of subjects reporting at least one newly diagnosed major illnesses, during the follow-up phase [from 1 month after the last study vaccination (Visit 5) through 6 months after the third study vaccination (Visit 6)] [ Time Frame: Month 7-12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The seroconversion rate for each of the 4 HPV antigens, 1 month after the third vaccination (Visit 5) of Gardasil® for subjects with baseline seronegative in Groups 1 and 3. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
Proportion of subjects with baseline seropositive for each of the 4 HPV antigens [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ), ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, ≥1:128 for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], [ Time Frame: Months 0, 3, 7 ] [ Designated as safety issue: No ]
PMB2948 [B24], PMB2707 [B44]) at each applicable blood draw time point. [ Time Frame: Months 0, 3, 7 ] [ Designated as safety issue: No ]
hSBA geometric mean titers (GMTs) for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], PMB2948 [B24], PMB2707 [B44]) at each applicable blood sampling time point. [ Time Frame: Months 0, 3, 7 ] [ Designated as safety issue: No ]

Enrollment:	2500
Study Start Date:	September 2011
Estimated Study Completion Date:	July 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1 rLP2086 + Gardasil	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.
Placebo Comparator: Group 2 rLP2086 and saline	Biological: rLP2086 Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
Active Comparator: Group 3 Saline + Gardasil	Biological: Gardasil Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461993

Show 74 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01461993 History of Changes
Other Study ID Numbers:	B1971011, 6108A1-2007
Study First Received:	September 28, 2011
Last Updated:	June 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

vaccine
rLP2086
Gardasil
HPV
meningitis B

N. meningitidis serogroup B
adolescents
single-blind
Meningococcal Vaccines

ClinicalTrials.gov processed this record on June 18, 2013