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: November 28, 2012
Last verified: November 2012
  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:
  • The primary endpoint for the co-primary objectives are the proportion of subjects achieving an rLP2086-specific SBA titer >=1:4 , for each of the 4 primary strains, measured 1 month after the third vaccination with rLP2086 vaccine (in groups 1 and 2). [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SBA titers for each of the 4 primary strains at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving an rLP2086-specific SBA titer 1:4, for each of the 4 primary strains, at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a 4-fold rise on rLP2086-specific SBA titer from baseline (day 1) to each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:8 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:16 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:32 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:64 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Proportions of subjects achieving rLP2086-specific SBA titers >=1:128 at each blood sampling time point [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Fold-rise for the following: • Fold-rise from baseline to month 7; • Fold-rise from baseline to month 3; • Fold-rise from baseline to month 2. [ Time Frame: day 1, month 2, month 3, month 7, ] [ Designated as safety issue: No ]
  • Incidence rates of local reactions, systemic events, use of anti-pyretic medication and unsolicted AEs/SAEs [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 1713
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

  Hide Study Locations
Locations
Czech Republic
Pfizer Investigational Site
Brandys nad Labem - Stara Boleslav, Czech Republic, 25001
Pfizer Investigational Site
Chlumec nad Cidlinou, Czech Republic, 50351
Pfizer Investigational Site
Holice, Czech Republic, 53401
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50005
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50002
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 50004
Pfizer Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
Pfizer Investigational Site
Odolena Voda, Czech Republic, 25070
Pfizer Investigational Site
Pardubice, Czech Republic, 53002
Pfizer Investigational Site
Pardubice, Czech Republic, 53012
Pfizer Investigational Site
Praha - Horni Pocernice, Czech Republic, 19300
Pfizer Investigational Site
Praha - Nusle, Czech Republic, 14000
Pfizer Investigational Site
Praha 1, Czech Republic, 11000
Pfizer Investigational Site
Praha 6, Czech Republic, 16000
Pfizer Investigational Site
Praha 6 - Petriny, Czech Republic, 16200
Pfizer Investigational Site
Sezemice, Czech Republic, 53304
Denmark
Pfizer Investigational Site
Aarhus N, Denmark, 8200
Finland
Pfizer Investigational Site
Espoo, Finland, 02100
Pfizer Investigational Site
Helsinki, Finland, 00930
Pfizer Investigational Site
Helsinki, Finland, 00100
Pfizer Investigational Site
Järvenpää, Finland, 04400
Pfizer Investigational Site
Kokkola, Finland, 67100
Pfizer Investigational Site
Lahti, Finland, 15140
Pfizer Investigational Site
Oulu, Finland, 90220
Pfizer Investigational Site
Pori, Finland, 28100
Pfizer Investigational Site
Seinäjoki, Finland, 60100
Pfizer Investigational Site
Tampere, Finland, 33100
Pfizer Investigational Site
Turku, Finland, 20520
Pfizer Investigational Site
Vantaa, Finland, 01300
Germany
Pfizer Investigational Site
Bad Saulgau, Germany, 88348
Pfizer Investigational Site
Bramsche, Germany, 49565
Pfizer Investigational Site
Kleve, Germany, 47533
Pfizer Investigational Site
Mainz, Germany, 55131
Pfizer Investigational Site
Neumuenster, Germany, 24534
Pfizer Investigational Site
Neustadt/Aisch, Germany, 91413
Poland
Pfizer Investigational Site
Debica, Poland, 39-200
Pfizer Investigational Site
Krakow, Poland, 31-223
Pfizer Investigational Site
Krakow, Poland, 31-202
Pfizer Investigational Site
Leczna, Poland, 21-010
Pfizer Investigational Site
Lubartow, Poland, 21-100
Pfizer Investigational Site
Lublin, Poland, 20-044
Pfizer Investigational Site
Oborniki Slaskie, Poland, 55-120
Pfizer Investigational Site
Poznan, Poland, 61-825
Pfizer Investigational Site
Siemianowice Slaskie, Poland, 41-103
Pfizer Investigational Site
Torun, Poland, 87-100
Pfizer Investigational Site
Trzebnica, Poland, 55-100
Spain
Pfizer Investigational Site
Sant Cugat Del Valles, Barcelona, Spain, 08195
Pfizer Investigational Site
Sant Vicenç Del Horts, Barcelona, Spain, 08620
Pfizer Investigational Site
Blanes, Girona, Spain, 17300
Pfizer Investigational Site
Almeria, Spain, 04120
Pfizer Investigational Site
Barcelona, Spain, 08042
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Valencia, Spain, 46020
Sweden
Pfizer Investigational Site
Eskilstuna, Sweden, 631 88
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Orebro, Sweden, 703 62
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
Study First Received: February 15, 2011
Last Updated: November 28, 2012
Health Authority: Iceland: Ministry of Health and Social Security

Keywords provided by Pfizer:
Healthy adolescents

ClinicalTrials.gov processed this record on October 23, 2014