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
NCT ID: NCT01299480
Last Updated: 2022-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1714 participants
INTERVENTIONAL
2011-03-03
2012-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group 1
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Group 2
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Group 3
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Group 4
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Group 5
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Interventions
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Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ordinace praktickeho lekare pro deti a dorost
Brandýs nad Labem-Stará Boleslav, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Chlumec nad Cidlinou, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Holice, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Odolena Voda, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Pardubice, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Pardubice, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Prague, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Prague, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Praha - Horni Pocernice, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Praha - Nusle, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Praha 6 - Petriny, , Czechia
Ordinace praktickeho lekare pro deti a dorost
Sezemice, , Czechia
Infektionsmedicinsk Afdeling Q
Aarhus N, , Denmark
Espoo Vaccine Research Clinic
Espoo, , Finland
Helsinki South Vaccine Research Clinic
Helsinki, , Finland
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Järvenpää Vaccine Research Clinic
Järvenpää, , Finland
Kokkola Vaccine Research Centre
Kokkola, , Finland
Lahti Vaccine Research Clinic
Lahti, , Finland
Oulu Vaccine Research Clinic
Oulu, , Finland
Porin Rokotetutkimusklinikka
Pori, , Finland
Seinäjoki Vaccine Research Clinic
Seinäjoki, , Finland
Tampere Vaccine Research Clinic
Tampere, , Finland
Turku Vaccine Research Clinic
Turku, , Finland
Vantaa East Vaccine Research Clinic
Vantaa, , Finland
Arztpraxis
Bad Saulgau, , Germany
Kinderarzt-Praxis
Bramsche, , Germany
Arztpraxis
Kleve, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Arztpraxis
Neumünster, , Germany
Kinderarztpraxis
Neumünster, , Germany
Kinderarztpraxis
Neustadt/Aisch, , Germany
Gabinet Lekarski
Dębica, , Poland
Krakowski Szpital Specjalistyczny, im. Jana Pawla II
Krakow, , Poland
NZOZ "Hipokrates-II" Sp. z o.o.
Krakow, , Poland
Nzoz "Anamed" S.C
Lubartów, , Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap
Lublin, , Poland
NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Śląskie, , Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem,
Poznan, , Poland
NZLA Michalkowice Jarosz i Partnerzy
Siemianowice Śląskie, , Poland
NZOZ Nasz Lekarz
Torun, , Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
Trzebnica, , Poland
NZOZ Salmed
Łęczna, , Poland
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Cap Vila Vella
SANT Vicenç DEL Horts, Barcelona, Spain
Institut Pediatric Mares-Riera
Blanes, Girona, Spain
Centro de Salud de Paiporta
Paiporta, Valencia, Spain
Centro de Salud Quart de Poblet
Quart de Poblet, Valencia, Spain
Hospital Virgen Del Mar
Almería, , Spain
Cap Roquetes-Canteres
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro de Salud Malvarrosa
Valencia, , Spain
Centro Superior de Investigacion en Salud Publica
Valencia, , Spain
Centro Superior de Salud Publica
Valencia, , Spain
Centro de Salud Republica Argentina
Valencia, , Spain
Centro de Salud Trafalgar
Valencia, , Spain
Malarsjukhuset, Infektionsmottagningen
Eskilstuna, , Sweden
Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum
Malmo, , Sweden
CRS, Clinical Research Support
Örebro, , Sweden
Countries
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References
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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.
Other Identifiers
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6108A1-2003
Identifier Type: OTHER
Identifier Source: secondary_id
2009-014493-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971012
Identifier Type: -
Identifier Source: org_study_id
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