Clinical trial NCT01352793: A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Official title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal
Keywords: phase 3 safety study
5700 healthy subjects
3 vaccine doses at month 0
2
and 6
control HAV/saline/HAV
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 5715
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

* Previous vaccination with Hepatitis A virus vaccine
* Previous vaccination with investigational meningococcal B vaccine
* History of culture-proven N. meningitidis serogroup B disease
* Any neuroinflammatory or autoimmune condition
* Any immune defect that would prevent an effective response to the study vaccine

Primary outcomes:
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
timeFrame: Vaccination 1 up to 6 months after Vaccination 3
measure: Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
timeFrame: Within 30 days after Vaccination 1
measure: Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
timeFrame: Within 30 days after Vaccination 2
measure: Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3
timeFrame: Within 30 days after Vaccination 3
Secondary outcomes:
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods
timeFrame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)
measure: Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods
timeFrame: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)
measure: Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods
timeFrame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)
measure: Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods
timeFrame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)
measure: Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination
timeFrame: Within 30 minutes after Vaccination 1, 2, 3
measure: Number of Days Participant Missed School or Work Due to Adverse Events (AEs)
timeFrame: Vaccination 1 up to 1 month after Vaccination 3
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Accelovance,Inc.
state: Alabama
city: Chandler
country: United States
facility: Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
state: Arizona
city: Chandler
country: United States
facility: Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
state: Arizona
city: Tempe
country: United States
facility: Cassidy Medical Group/Clinical Research Advantage
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: San Diego
country: United States
facility: Accelovance. Inc
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: Vista
country: United States
facility: Cassidy Medical Group/Clinical Research Advantage
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Optimal Research, LLC
state: Florida
city: Melbourne
country: United States
facility: Accelovance
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Mishawaka
country: United States
facility: Accelovance,Inc.
state: Indiana
city: Council Bluffs
country: United States
facility: Clinical Research Advantage,Inc/Ridge Family Practice
state: Iowa
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Fremont
country: United States
facility: Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP
state: Nebraska
city: Fremont
country: United States
facility: Prairie Fields Family Medicine/Clinical Research Advantage
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research. Inc.
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Katy
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. - Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. - Jordan River Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville
state: Virginia
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Sherwood
country: Australia
facility: AusTrials Pty Ltd
state: Queensland
city: North Adelaide
country: Australia
facility: Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics
state: South Australia
city: Subiaco
country: Australia
facility: Telethon Institute for Child Health Research
city: Temuco
country: Chile
facility: Centro De Investigacion Clinica Del Sur
state: Araucania
city: Santiago
country: Chile
facility: Hospital Clinico de la Pontificia Universidad Catolica de Chile/
state: Region Metropolitana
city: Santiago
country: Chile
facility: Centro de Estudios de Vacunas, CESFAM Gabriela Mistral
state: Region Metropolitana
city: Conchali
country: Chile
facility: Cesfam Dr. Jose Symon Ojeda
state: Santiago
city: Santiago
country: Chile
facility: Hospital Luis Calvo Mackenna
city: Jindrichuv Hradec
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
city: Plzen
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 2
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Tynec nad Sazavou
country: Czech Republic
facility: Prakticky Lekar Pro Deti a Mladez
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Skejby
city: Rakvere
country: Estonia
facility: Eraarst Kersti Veidrik Ou
city: Tallinn
country: Estonia
facility: Innomedica OU
city: Tallinn
country: Estonia
facility: Merekivi Perearstid OU
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Hamburg
country: Germany
facility: Clinical Trial Center North
city: Hamburg
country: Germany
facility: Clinical Trial Center North GmbH & Co.KG
city: Hamburg
country: Germany
facility: Bernhard Nocht Centre for Clinical Trials (BNCCT)
city: Wuerzburg
country: Germany
facility: Juliusspital Wuerzburg
city: Kaunas
country: Lithuania
facility: JSC "InMedica"
city: Kaunas
country: Lithuania
facility: Saules Family Medicine Centre
city: Kaunas
country: Lithuania
facility: Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases
city: Kaunas
country: Lithuania
facility: LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE
city: Vilnius
country: Lithuania
facility: Centro poliklinika, Public Institution
city: Debica
country: Poland
facility: Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im Jana Pawla II
city: Krakow
country: Poland
facility: Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
city: Lubartow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
city: Oborniki Slaskie
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
city: Poznan
country: Poland
facility: Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
city: Siemianowice Slaskie
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
city: Valencia
country: Spain
facility: Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir
city: Malmo
country: Sweden
facility: Vaccinenheten Barn- och ungdomsmedicinska kliniken
state: SE
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus, Institution för Pediatrik
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.