Clinical trial NCT00808028: A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Official title: A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis, Meningococcal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 538
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment.
* 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:

* History of any invasive meningococcal disease.
* 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.

Primary outcomes:
measure: Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
timeFrame: Before vaccination 1 up to 1 month after vaccination 2
measure: Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
timeFrame: Before vaccination 1 up to 1 month after vaccination 3
measure: Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
timeFrame: Vaccination 1 upto 1 Month after vaccination 3
measure: Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
timeFrame: 6 month after vaccination 3 up to 48 months
Secondary outcomes:
measure: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
timeFrame: 1 month before vaccination 1, 1 month after vaccination 2, 3
Other outcomes:
measure: Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
timeFrame: Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3
Locations:
city: Herston
country: Australia
facility: Queensland Paediatric Infectious Diseases (QPID) Laboratory
state: Queensland
city: North Adelaide
country: Australia
facility: Department of Paediatrics, Women's & Children's Hospital
state: South Australia
city: Carlton
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Subiaco
country: Australia
facility: Children's Clinical Research Facility, Vaccine Trials Group (VTG),
state: Western Australia
city: Debica
country: Poland
facility: ZOZ w Debicy, Poradnia Chorob Zakaznych
city: Krakow
country: Poland
facility: SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
city: Krakow
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
city: Leczna
country: Poland
facility: NZOZ Salmed
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
city: Lubartow
country: Poland
facility: SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
city: Lublin
country: Poland
facility: Eskulap Sp. z o. o., ul. Weteranow 46
city: Melno
country: Poland
facility: SP ZOZ, Poradnia Dziecieca w Grucie
city: Oborniki Slaskie
country: Poland
facility: NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
city: Poznan
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
city: Siemianowice Slaskie
country: Poland
facility: NZLA Michalkowice, Jarosz i Partnerzy
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
city: Trzebnica
country: Poland
facility: Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
city: Wroclaw
country: Poland
facility: Klinika Pediatrii i Chorob Infekcyjnych
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: La Coruna
city: Getafe
country: Spain
facility: Hospital U. de Getafe
state: Madrid
city: Vigo
country: Spain
facility: Complexo Hospitalario Xeral-Cies de Vigo
state: Pontevedra
city: Almeria
country: Spain
facility: Clinica Virgen del Mar
city: Barcelona
country: Spain
facility: Hospital General de Cataluna
city: Madrid
country: Spain
facility: Hospital U. 12 de Octubre
city: Valencia
country: Spain
facility: Centro de Salud Nazaret
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.