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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01352793
First received: May 11, 2011
Last updated: April 11, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352793

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  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: April 11, 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
Meningitis, Bacterial
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014