A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

NCT01830855

Last updated date
Study Location
Birmingham Pediatric Associates, PC
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female subject aged >=10 and <19 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Previous vaccination with any meningococcal serogroup B vaccine.


2. Subjects who have received prior HAV vaccination.


3. 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.


4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.


5. 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.


6. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).


7. Current chronic use of systemic antibiotics.


8. Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.


9. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ?10 to <19 Years
Official Title  ICMJE A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years
Brief Summary This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE
  • Biological: rLP2086
    0.5 mL dose, given at 0, 2 and 6 months (lot 1)
  • Biological: rLP2086
    0.5 mL dose, given at 0, 2 and 6 months (lot 2)
  • Biological: rLP2086
    0.5 mL dose, given at 0, 2 and 6 months (lot 3)
  • Biological: Havrix (HAV)
    0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
  • Biological: Saline
    0.5 mL dose of sterile normal saline for injection.
Study Arms  ICMJE
  • Experimental: rLP2086 lot 1
    Intervention: Biological: rLP2086
  • Experimental: rLP2086 lot 2
    Intervention: Biological: rLP2086
  • Experimental: rLP2086 lot 3
    Intervention: Biological: rLP2086
  • Active Comparator: Control
    Havrix (HAV) and Saline
    Interventions:
    • Biological: Havrix (HAV)
    • Biological: Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
3596
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2013)
3600
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subject aged >=10 and <19 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 have received prior HAV vaccination.
  3. 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.
  4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  5. 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.
  6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  7. Current chronic use of systemic antibiotics.
  8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
  9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   Finland,   Germany,   Italy,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01830855
Other Study ID Numbers  ICMJE B1971009
6108A1-3001 ( Other Identifier: Alias Study Number )
2010-023873-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP