A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01299480
First received: February 15, 2011
Last updated: June 2, 2015
Last verified: June 2015
  Purpose

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.


Condition Intervention Phase
Meningococcal Vaccine
Biological: Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants [ Time Frame: 1 month after Injection 4 ] [ Designated as safety issue: No ]
  • Percentage of Participants Reporting At Least 1 Adverse Event (AE) [ Time Frame: Injection 1 up to 1 month after Injection 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants [ Time Frame: 1 month after Injection 4 ] [ Designated as safety issue: No ]
  • Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) [ Time Frame: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving hSBA Titer >=LLOQ [ Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level [ Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer [ Time Frame: 1 month after Injection 2, 3, 4 ] [ Designated as safety issue: No ]

Enrollment: 1714
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Name: Group 1
Experimental: Group 2
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Name: Group 2
Experimental: Group 3
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Name: Group 3
Experimental: Group 4
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Name: Group 4
Experimental: Group 5
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Name: Group 5

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
  • Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Male or female subject aged ≥11 and <19 years at the time of enrollment.
  • Available for the entire study period and can be reached by telephone.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
  • Negative urine pregnancy test for female subjects.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
  • Current chronic use of systemic antibiotics.
  • Participation in other studies during study participation. Participation in purely observational studies is acceptable.
  • Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  • Subject is pregnant or breastfeeding.
  • Subject is a direct descendant of study site or Pfizer personnel
  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: NCT01299480

  Show 63 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: NCT01299480     History of Changes
Other Study ID Numbers: B1971012, 6108A1-2003, 2009-014493-18
Study First Received: February 15, 2011
Results First Received: November 21, 2014
Last Updated: June 2, 2015
Health Authority: Iceland: Ministry of Health and Social Security

Keywords provided by Pfizer:
Healthy adolescents

ClinicalTrials.gov processed this record on July 30, 2015