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

A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens 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 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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Biological: Vaccine; Biological: Vaccine; Biological: Vaccine; Biological: Vaccine; Biological: Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1714
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brandys nad Labem - Stara Boleslav, Czechia, 25001
    • Ordinace praktického lékaře pro děti a dorost
  • Chlumec nad Cidlinou, Czechia, 50351
    • Ordinace praktického lékaře pro děti a dorost
  • Holice, Czechia, 53401
    • Ordinace praktického lékaře pro děti a dorost
  • Hradec Kralove, Czechia, 50005
    • Fakultni nemocnice Hradec Kralove
  • Hradec Kralove, Czechia, 50004
    • Ordinace praktického lékaře pro děti a dorost
  • Hradec Kralove, Czechia, 50002
    • Ordinace praktického lékaře pro děti a dorost
  • Jindrichuv Hradec, Czechia, 37701
    • Ordinace praktického lékaře pro děti a dorost
  • Odolena Voda, Czechia, 25070
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 53002
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 53012
    • Ordinace praktického lékaře pro děti a dorost
  • Praha - Horni Pocernice, Czechia, 19300
    • Ordinace praktického lékaře pro děti a dorost
  • Praha - Nusle, Czechia, 14000
    • Ordinace praktického lékaře pro děti a dorost
  • Praha 1, Czechia, 11000
    • Ordinace praktického lékaře pro děti a dorost
  • Praha 6, Czechia, 16000
    • Ordinace praktického lékaře pro děti a dorost
  • Praha 6 - Petriny, Czechia, 16200
    • Ordinace praktického lékaře pro děti a dorost
  • Sezemice, Czechia, 53304
    • Ordinace praktického lékaře pro děti a dorost
• Denmark
  • Aarhus N, Denmark, 8200
    • Infektionsmedicinsk Afdeling Q
• Finland
  • Espoo, Finland, 02230
    • Espoo Vaccine Research Clinic
  • Helsinki, Finland, 00100
    • Helsinki South Vaccine Research Clinic
  • Helsinki, Finland, 00930
    • Helsinki East Vaccine Research Clinic
  • Järvenpää, Finland, 04400
    • Järvenpää Vaccine Research Clinic
  • Kokkola, Finland, 67100
    • Kokkola Vaccine Research Centre
  • Lahti, Finland, 15140
    • Lahti Vaccine Research Clinic
  • Oulu, Finland, 90220
    • Oulu Vaccine Research Clinic
  • Pori, Finland, 28100
    • Porin Rokotetutkimusklinikka
  • Seinäjoki, Finland, 60100
    • Seinäjoki Vaccine Research Clinic
  • Tampere, Finland, 33100
    • Tampere Vaccine Research Clinic
  • Turku, Finland, 20520
    • Turku Vaccine Research Clinic
  • Vantaa, Finland, 01300
    • Vantaa East Vaccine Research Clinic
• Germany
  • Bad Saulgau, Germany, 88348
    • Arztpraxis
  • Bramsche, Germany, 49565
    • Kinderarzt-Praxis
  • Kleve, Germany, 47533
    • Arztpraxis
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Neumuenster, Germany, 24534
    • Arztpraxis
  • Neumuenster, Germany, 24534
    • Kinderarztpraxis
  • Neustadt/Aisch, Germany, 91413
    • Kinderarztpraxis
• Poland
  • Debica, Poland, 39-200
    • Gabinet Lekarski
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny, im. Jana Pawla II
  • Krakow, Poland, 31-223
    • NZOZ "HIPOKRATES-II" Sp. z o.o.
  • Leczna, Poland, 21-010
    • NZOZ Salmed
  • Lubartow, Poland, 21-100
    • Nzoz "Anamed" S.C
  • Lublin, Poland, 20-044
    • NZOZ Praktyka Lekarza Rodzinnego Eskulap
  • Oborniki Slaskie, Poland, 55-120
    • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
  • Poznan, Poland, 61709
    • Specjalistyczny ZOZ nad Matka i Dzieckiem,
  • 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
• Spain
  • Almeria, Spain, 04120
    • Hospital Virgen del Mar
  • Barcelona, Spain, 08042
    • Cap Roquetes-Canteres
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46011
    • Centro de Salud Malvarrosa
  • Valencia, Spain, 46023
    • Centro de Salud Trafalgar
  • Valencia, Spain, 46020
    • Centro Superior de Investigacion en Salud Publica
  • Valencia, Spain, 46020
    • Centro Superior de Salud Publica
  • Valencia, Spain, 46021
    • Centro de Salud Republica Argentina
  • Barcelona
    • SANT Vicenç DEL Horts, Barcelona, Spain, 08620
      • Cap Vila Vella
    • Sant Cugat Del Valles, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • Girona
    • Blanes, Girona, Spain, 17300
      • Institut Pediatric Mares-Riera
  • Valencia
    • Paiporta, Valencia, Spain, 46200
      • Centro de Salud de Paiporta
    • Quart de Poblet, Valencia, Spain, 46930
      • Centro de Salud Quart de Poblet
• Sweden
  • Eskilstuna, Sweden, 631 88
    • Malarsjukhuset, Infektionsmottagningen
  • Malmo, Sweden, 205 02
    • Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum
  • Orebro, Sweden, 703 62
    • CRS, Clinical Research Support

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• 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, 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Group 1; Biological: Vaccine; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; Other Names: Group 2; Biological: Vaccine; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; Other Names: Group 3; Biological: Vaccine; rLP2086 at visits 1 and 3, saline at visits 2 and 5; Other Names: Group 4; Biological: Vaccine; rLP2086 at visits 3 and 5, saline at visits 1 and 2; Other Names: Group 5
Experimental: Group 2; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2	Biological: Vaccine; rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3; Other Names: Group 1; Biological: Vaccine; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; Other Names: Group 2; Biological: Vaccine; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; Other Names: Group 3; Biological: Vaccine; rLP2086 at visits 1 and 3, saline at visits 2 and 5; Other Names: Group 4; Biological: Vaccine; rLP2086 at visits 3 and 5, saline at visits 1 and 2; Other Names: Group 5
Experimental: Group 3; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3	Biological: Vaccine; rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3; Other Names: Group 1; Biological: Vaccine; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; Other Names: Group 2; Biological: Vaccine; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; Other Names: Group 3; Biological: Vaccine; rLP2086 at visits 1 and 3, saline at visits 2 and 5; Other Names: Group 4; Biological: Vaccine; rLP2086 at visits 3 and 5, saline at visits 1 and 2; Other Names: Group 5
Experimental: Group 4; rLP2086 at visits 1 and 3, saline at visits 2 and 5	Biological: Vaccine; rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3; Other Names: Group 1; Biological: Vaccine; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; Other Names: Group 2; Biological: Vaccine; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; Other Names: Group 3; Biological: Vaccine; rLP2086 at visits 1 and 3, saline at visits 2 and 5; Other Names: Group 4; Biological: Vaccine; rLP2086 at visits 3 and 5, saline at visits 1 and 2; Other Names: Group 5
Experimental: Group 5; rLP2086 at visits 3 and 5, saline at visits 1 and 2	Biological: Vaccine; rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3; Other Names: Group 1; Biological: Vaccine; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; Other Names: Group 2; Biological: Vaccine; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; Other Names: Group 3; Biological: Vaccine; rLP2086 at visits 1 and 3, saline at visits 2 and 5; Other Names: Group 4; Biological: Vaccine; rLP2086 at visits 3 and 5, saline at visits 1 and 2; Other Names: Group 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 month after Injection 4
Percentage of Participants Reporting At Least 1 Adverse Event (AE)	Injection 1 up to 1 month after Injection 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants	1 month after Injection 4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)	Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Percentage of Participants Achieving hSBA Titer >=LLOQ	Before Injection 1, 1 Month after Injection 2, 3, 4
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level	Before Injection 1, 1 Month after Injection 2, 3, 4

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer	1 month after Injection 2, 3, 4

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, Ostergaard L, Diez-Domingo J, Wysocki J, Flodmark CE, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Crowther G, Perez JL. Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):152-60. doi: 10.1093/jpids/piv039. Epub 2015 Aug 4.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2011
• Primary Completion (Actual): May 3, 2012
• Study Completion (Actual): September 18, 2012

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 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: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: B1971012; 6108A1-2003 (Other Identifier: Alias Study Number); 2009-014493-18 (EudraCT Number)