A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01323270
First received: February 17, 2011
Last updated: April 27, 2015
Last verified: April 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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.


Condition Intervention Phase
Meningococcal Vaccine
rLP2086
Repevax
N Meningitidis Serogroup B
Meningitis
Biological: rLP2086
Biological: Repevax
Biological: Saline
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 Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >/= 11 To <19 Years

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen [ Time Frame: 1 month after Vaccination 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens [ Time Frame: 1 month after Vaccination 1 ] [ Designated as safety issue: No ]
  • GMC for Acellular Pertussis Antigens [ Time Frame: 1 month after Vaccination 1 ] [ Designated as safety issue: No ]
    Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)

  • Geometric Mean Titer (GMT) for Poliomyelitis Antigens [ Time Frame: 1 month after Vaccination 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level [ Time Frame: 1 month after Vaccination 3 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT) [ Time Frame: Before vaccination 1, 1 month after Vaccination 2, 3 ] [ Designated as safety issue: No ]
  • Geometric Mean Fold-Rise (GMFR) for IgG [ Time Frame: Before Vaccination 1, 1 month after Vaccination 2, 3 ] [ Designated as safety issue: No ]

Enrollment: 753
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rLP2086
rLP2086 and Repevax
Biological: rLP2086
0.5 mL dose, given at 0, 2 and 6 months.
Biological: Repevax
0.5 mL dose, given at 0 months.
Placebo Comparator: Saline and Repevax
Saline and Repevax
Biological: Saline
0.5 mL dose, given at 0, 2 and 6 months.
Biological: Repevax
0.5 mL dose, given at 0 months.

  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, 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.
  • Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
  • 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.
  • Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
  • 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 a direct descendant (eg, child, grandchild or other family member) of study site or Pfizer personnel.
  • Subject is pregnant or breastfeeding.
  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: NCT01323270

Locations
Finland
Espoo Vaccine Research Clinic
Espoo, Finland, 02100
Helsinki South Vaccine Research Clinic
Helsinki, Finland, 00100
Ita-Helsinki Vaccine Research Clinic
Helsinki, Finland, 00930
Järvenpää Vaccine Research Clinic
Järvenpää, Finland, 04400
Kokkola Vaccine Research Clinic
Kokkola, Finland, 67100
Lahti Vaccine Research Clinic
Lahti, Finland, 15140
Oulu Vaccine Research Clinic
Oulu, Finland, 90220
Pori Vaccine Research Clinic
Pori, Finland, 28100
Seinäjoki Vaccine Research Clinic
Seinäjoki, Finland, 60100
Tampere Vaccine Research Clinic
Tampere, Finland, 33100
Tampereen Yliopisto University Of Tampere
Tampere, Finland, 33014
Vaccine Research Center
Tampere, Finland, FIN-33014
Turku Vaccine Research Clinic
Turku, Finland, 20520
Vantaa Vaccine Research Clinic
Vantaa, Finland, 01300
Germany
Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf
Bad Sobernheim, Germany, 55566
Gerhard Bleckmann Kinder- und Jugendarzt
Baunatal, Germany, 34225
Kinderarzt-Praxis
Bramsche, Germany, 49565
Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel
Kehl, Germany, 77694
Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin
Luebeck, Germany, 23566
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany, 55131
Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte
Schwaebisch-Hall, Germany, 74523
Thomas Lenz & (Frau) Dr. med. Marin Eggers
Vellmar, Germany, 34246
Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche
Weilheim, Germany, 82362
Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim
Welzheim, Germany, 73642
Poland
Gabinet Lekarski
Debica, Poland, 39-200
Krakowski Szpital Specjalistyczny, im. Jana Pawla II
Krakow, Poland, 31-202
NZOZ Salmed
Leczna, Poland, 21-010
Specjalistyczna Praktyka Lekarska Gravita
Lodz, Poland, 91-347
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny
Lubartow, Poland, 21-100
NZOZ Praktyka Lekarza Rodzinnego Eskulap
Lublin, Poland, 20-044
NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Slaskie, Poland, 55-120
Specjalistyczny ZOZ nad Matka i Dzieckiem, Przychodnia Wieku Rozwojowego
Poznan, Poland, 61-825
NZLA Michalkowice Jarosz i Partnerzy
Siemianowice Slaskie, Poland, 41-103
NZOZ Nasz Lekarz
Torun, Poland, 87-100
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
Trzebnica, Poland, 55-100
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, Poland, 50-345
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: NCT01323270     History of Changes
Other Study ID Numbers: B1971010, 6108A1-2008, 2010-022449-38
Study First Received: February 17, 2011
Results First Received: November 21, 2014
Last Updated: April 27, 2015
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Pfizer:
Healthy adolescents

ClinicalTrials.gov processed this record on September 02, 2015