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.

NCT01323270 | Completed Phase 2 Results DMC

• 3 other identifiers: B19710106108A1-20082010-022449-38
• Study Type: interventional
• Target: 753
• Locations: 3 countries
• Sites: 36

Brief Summary

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.

Conditions

Meningococcal Vaccine; rLP2086; Repevax; N Meningitidis Serogroup B; Meningitis

Keywords

Healthy adolescents

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen

  1 month after Vaccination 1

• Percentage of Participants With at Least One Adverse Event (AE)

  Vaccination 1 up to 1 month after Vaccination 3

Secondary Outcomes (4)

• Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens

  1 month after Vaccination 1

• GMC for Acellular Pertussis Antigens

  1 month after Vaccination 1

• Geometric Mean Titer (GMT) for Poliomyelitis Antigens

  1 month after Vaccination 1

• Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level

  1 month after Vaccination 3

Other Outcomes (2)

• Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)

  Before vaccination 1, 1 month after Vaccination 2, 3

• Geometric Mean Fold-Rise (GMFR) for IgG

  Before Vaccination 1, 1 month after Vaccination 2, 3

Study Arms (2)

rLP2086

EXPERIMENTAL

rLP2086 and Repevax

Biological: rLP2086; Biological: Repevax

Saline and Repevax

PLACEBO COMPARATOR

Saline and Repevax

Biological: Saline; Biological: Repevax

Interventions

rLP2086 BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months.

rLP2086

Repevax BIOLOGICAL

0.5 mL dose, given at 0 months.

rLP2086

Saline BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months.

Saline and Repevax

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (36)

Espoo Vaccine Research Clinic

Espoo, 02100, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Ita-Helsinki Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Järvenpää Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Lahti Vaccine Research Clinic

Lahti, 15140, Finland

Location

Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampereen Yliopisto University Of Tampere

Tampere, 33014, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Vaccine Research Center

Tampere, FIN-33014, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Vantaa Vaccine Research Clinic

Vantaa, 01300, Finland

Location

Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf

Bad Sobernheim, 55566, Germany

Location

Gerhard Bleckmann Kinder- und Jugendarzt

Baunatal, 34225, Germany

Location

Kinderarzt-Praxis

Bramsche, 49565, Germany

Location

Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel

Kehl, 77694, Germany

Location

Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin

Lübeck, 23566, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, 55131, Germany

Location

Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte

Schwäbisch Hall, 74523, Germany

Location

Thomas Lenz & (Frau) Dr. med. Marin Eggers

Vellmar, 34246, Germany

Location

Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche

Weilheim, 82362, Germany

Location

Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim

Welzheim, 73642, Germany

Location

Gabinet Lekarski

Dębica, 39-200, Poland

Location

Krakowski Szpital Specjalistyczny, im. Jana Pawla II

Krakow, 31-202, Poland

Location

Specjalistyczna Praktyka Lekarska Gravita

Lodz, 91-347, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny

Lubartów, 21-100, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Eskulap

Lublin, 20-044, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, 55-120, Poland

Location

Specjalistyczny ZOZ nad Matka i Dzieckiem, Przychodnia Wieku Rozwojowego

Poznan, 61-825, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy

Siemianowice Śląskie, 41-103, Poland

Location

NZOZ Nasz Lekarz

Torun, 87-100, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

Trzebnica, 55-100, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, 50-345, Poland

Location

NZOZ Salmed

Łęczna, 21-010, Poland

Location

Related Publications (3)

• Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

  PMID: 35164991 DERIVED

• Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.

  PMID: 32681472 DERIVED

• Vesikari T, Wysocki J, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Perez JL. Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):180-7. doi: 10.1093/jpids/piv064. Epub 2016 Jan 23.

  PMID: 26803328 DERIVED

MeSH Terms

Conditions

Meningitis

Interventions

factor H-binding protein, Neisseria meningitidis; Sodium Chloride

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: March 25, 2011
• Study Start: March 18, 2011
• Primary Completion: October 8, 2012
• Study Completion: February 19, 2013
• Last Updated: October 27, 2022
• Results First Posted: November 26, 2014

Record last verified: 2022-10

Locations

PL (12); DE (10); FI (14)