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.

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 Greater Than Or Equal To 11 To <19 Years

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.

Study Overview

• Status: Completed
• Conditions: Meningitis; Meningococcal Vaccine; rLP2086; Repevax; N Meningitidis Serogroup B
• Intervention / Treatment: Biological: rLP2086; Biological: Repevax; Biological: Saline

• Study Type: Interventional
• Enrollment (Actual): 753
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Biological: Repevax; 0.5 mL dose, given at 0 months.; Biological: Saline; 0.5 mL dose, given at 0, 2 and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With at Least One Adverse Event (AE)	Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen	1 month after Vaccination 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens		1 month after Vaccination 1
GMC for Acellular Pertussis Antigens	Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)	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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2011
• Primary Completion (Actual): October 8, 2012
• Study Completion (Actual): February 19, 2013

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Healthy adolescents
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis
• Other Study ID Numbers: B1971010; 6108A1-2008 (Other Identifier: Alias Study Number); 2010-022449-38 (EudraCT Number)