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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01352793
First received: May 11, 2011
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.


Condition Intervention Phase
Meningitis, Meningococcal
Biological: rLP2086 vaccine
Biological: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active Controlled, Observer Blinded Trial to Assess the Safety and Tolerability of a Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rLP2086) Vaccine Given in Healthy Subjects Aged ≥10 to <26 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of subjects with at least one SAE occurring during the time period from the first study vaccination through 6 months after last study vaccination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with at least one medically attended adverse event occurring during the time period within 30 days after each vaccination. [ Time Frame: 1, 3, 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with at least 1 SAE 30 days after each vaccination, any vaccination, during the vaccination phase, and during the follow-up phase. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with at least 1 newly diagnosed chronic 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: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with at least 1 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: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects reporting at least 1 immediate AE after each vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Subject's days missing school or work due to AEs during the vaccination phase [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 5700
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086 vaccine
rLP2086 vaccine
Biological: rLP2086 vaccine
120 mcg, 3 doses, at month 0, 2, and 6.
control
The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
Biological: control
HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

  • Previous vaccination with Hepatitis A virus vaccine
  • Previous vaccination with investigational meningococcal B vaccine
  • History of culture-proven N. meningitidis serogroup B disease
  • Any neuroinflammatory or autoimmune condition
  • Any immune defect that would prevent an effective response to the study vaccine
  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: NCT01352793

  Show 78 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: NCT01352793     History of Changes
Other Study ID Numbers: B1971014
Study First Received: May 11, 2011
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
phase 3 safety study
5700 healthy subjects
3 vaccine doses at month 0
2
and 6
control HAV/saline/HAV

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014