A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
NCT ID: NCT00808028
Last Updated: 2015-04-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
538 participants
INTERVENTIONAL
2009-02-28
2014-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
NCT00387725
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
NCT01299480
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
NCT01352793
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
NCT00387569
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
NCT00879814
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
dose level 1 rLP2086 vaccine
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
2
dose level 2 rLP2086 vaccine
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
3
dose level 3 rLP2086 vaccine
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
4
normal saline (placebo)
normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Negative urine pregnancy test for all female subjects.
* Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion Criteria
* A previous anaphylactic or severe vaccine-associated adverse reaction.
* Any clinically significant chronic disease.
* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
* Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
11 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, Australia
Department of Paediatrics, Women's & Children's Hospital
North Adelaide, South Australia, Australia
Royal Children's Hospital
Carlton, Victoria, Australia
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
Subiaco, Western Australia, Australia
ZOZ w Debicy, Poradnia Chorob Zakaznych
Dębica, , Poland
SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Krakow, , Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
Krakow, , Poland
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lodz, , Poland
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, , Poland
SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
Lubartów, , Poland
Eskulap Sp. z o. o., ul. Weteranow 46
Lublin, , Poland
SP ZOZ, Poradnia Dziecieca w Grucie
Mełno, , Poland
NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Śląskie, , Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
Poznan, , Poland
NZLA Michalkowice, Jarosz i Partnerzy
Siemianowice Śląskie, , Poland
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
Torun, , Poland
Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
Trzebnica, , Poland
Klinika Pediatrii i Chorob Infekcyjnych
Wroclaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, , Poland
NZOZ Salmed
Łęczna, , Poland
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruna, Spain
Hospital U. de Getafe
Getafe, Madrid, Spain
Hospital U. 12 de Octubre
Madrid, Madrid, Spain
Complexo Hospitalario Xeral-Cies de Vigo
Vigo, Pontevedra, Spain
Clinica Virgen del Mar
Almería, , Spain
Hospital General de Cataluna
Barcelona, , Spain
Centro de Salud Nazaret
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Marshall HS, Richmond PC, Beeslaar J, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Lee SS, Perez JL; 6108A12001 Study Investigators. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017 Jan;17(1):58-67. doi: 10.1016/S1473-3099(16)30314-0. Epub 2016 Oct 11.
Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1971005
Identifier Type: OTHER
Identifier Source: secondary_id
2008-007789-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6108A1-2001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.