A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years. (B1971016)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01352845
First received: May 11, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.


Condition Intervention Phase
Healthy
Biological: rLP2086
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered As a 3-dose Regimen in Healthy Young Adults Aged >=18 to <26 Years

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects with titer ≥ lower limit of quantitation (LLOQ) for all of the 4 primary test strains combined, at 1 month after the third vaccination with bivalent rLP2086 vaccine. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 4- fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains. [ Time Frame: Baseline, month 7 ] [ Designated as safety issue: No ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit. [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit. [ Time Frame: Month 2 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 SAE 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period. [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccination and during the vaccination phase. [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting at least 1 immediate AE after each vaccination. [ Time Frame: Month 0 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting at least 1 immediate AE after each vaccination. [ Time Frame: Month 2 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting at least 1 immediate AE after each vaccination. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Subject's days missing school or work due to AEs during the vaccination phase. [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with a titer ≥ lower limit of quantitation (LLOQ) for each of 10 test strains 1 month after the third vaccination. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary test strains at baseline with bivalent rLP2086 vaccine. [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary test strains 1 month after the second vaccination with bivalent rLP2086 vaccine. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 4- fold increase in titer from baseline to 1 month after the second vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets. [ Time Frame: Baseline, month 3 ] [ Designated as safety issue: No ]
  • Geometric mean titers at baseline with bivalent rLP2086 for each of the primary test strain sets. [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Geometric mean titers 1 month after the second vaccination with bivalent rLP2086 for each of the primary test strain sets. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Geometric mean titers 1 month after the third vaccination with bivalent rLP2086 for each of the primary test strain sets. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving hSBA titers of ≥LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at baseline for each of the primary test strains sets. [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving hSBA titers of ≥LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 1 month after the second vaccination with bivalent rLP2086 vaccine for each of the [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • primary test strains sets. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving hSBA titers of ≥LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • primary test strains sets. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 3- fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets. [ Time Frame: Baseline, month 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving at least a 2- fold increase in titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the primary test strains sets. [ Time Frame: Baseline, month 7 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a titer ≥ lower limit of quantitation (LLOQ) for each of 10 test strains at baseline [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving hSBA titers of ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at baseline for each of 10 test strains. [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving hSBA titers of ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 1 month after the third vaccination with bivalent rLP2086 vaccine for each of 10 test strains. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
  • Geometric mean titers at baseline for each of 10 test strain sets. [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Geometric mean titers 1 month after the third vaccination with bivalent rLP2086 for each of 10 test strain sets. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3300
Study Start Date: May 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086 Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months
Placebo Comparator: Control
Steril normal saline solution
Other: Placebo
0.5 mL dose, given at 0, 2 and 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subject aged >=18 and <26 years at the time of enrollment.
  2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

  1. Previous vaccination with any meningococcal serogroup B vaccine.
  2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
  3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  4. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
  5. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  6. Current chronic use of systemic antibiotics.
  7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
  8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352845

  Show 62 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01352845     History of Changes
Other Study ID Numbers: B1971016, 6108A1-2004
Study First Received: May 11, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 20, 2014