A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Phase 3

Completed

Conditions: Meningitis, Meningococcal

Interventions: Biological: control
Biological: rLP2086 vaccine

Registration Number: NCT01352793

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5715

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.
rLP2086 vaccine	rLP2086 vaccine	rLP2086 vaccine

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study	Vaccination 1 up to 6 months after Vaccination 3	An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1	Within 30 days after Vaccination 1	A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2	Within 30 days after Vaccination 2	A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3	Within 30 days after Vaccination 3	A medically attended AE was defined as a non-serious AE that required medical attention.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination	Within 30 minutes after Vaccination 1, 2, 3	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Number of Days Participant Missed School or Work Due to Adverse Events (AEs)	Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods	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)	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods	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)	A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods	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)	A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods	Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.

Trial Locations

Locations (77): Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
🇺🇸
Tempe, Arizona, United States
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
🇺🇸
Tempe, Arizona, United States
Optimal Research, LLC
🇺🇸
Melbourne, Florida, United States
Accelovance. Inc
🇺🇸
San Diego, California, United States
Centro de Estudios de Vacunas, CESFAM Gabriela Mistral
🇨🇱
Santiago, Region Metropolitana, Chile
Hospital Luis Calvo Mackenna
🇨🇱
Santiago, Chile
Hospital Clinico de la Pontificia Universidad Catolica de Chile/
🇨🇱
Santiago, Region Metropolitana, Chile
Samostatna ordinace praktickeho lekare pro deti a dorost
🇨🇿
Jindrichuv Hradec, Czech Republic
Merekivi Perearstid OU
🇪🇪
Tallinn, Estonia
Krakowski Szpital Specjalistyczny im Jana Pawla II
🇵🇱
Krakow, Poland
Prakticky Lekar Pro Deti a Mladez
🇨🇿
Tynec nad Sazavou, Czech Republic
Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱
Krakow, Poland
Innomedica OU
🇪🇪
Tallinn, Estonia
Merelahe Family Doctors Centre
🇪🇪
Tallinn, Estonia
LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE
🇱🇹
Kaunas, Lithuania
NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
🇵🇱
Oborniki Slaskie, Poland
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
🇵🇱
Siemianowice Slaskie, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
🇵🇱
Wroclaw, Poland
NZOZ Nasz Lekarz
🇵🇱
Torun, Poland
Jean Brown Research
🇺🇸
Salt Lake City, Utah, United States
Accelovance,Inc.
🇺🇸
Mishawaka, Indiana, United States
Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
🇺🇸
Chandler, Arizona, United States
Cassidy Medical Group/Clinical Research Advantage
🇺🇸
Vista, California, United States
Harrisburg Family Medical Center
🇺🇸
Harrisburg, Arkansas, United States
Benchmark Research
🇺🇸
Fort Worth, Texas, United States
Avail Clinical Research, LLC
🇺🇸
DeLand, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Accelovance
🇺🇸
Melbourne, Florida, United States
Miami Research Associates
🇺🇸
South Miami, Florida, United States
Clinical Research Advantage,Inc/Ridge Family Practice
🇺🇸
Council Bluffs, Iowa, United States
Kentucky Pediatric/Adult Research
🇺🇸
Bardstown, Kentucky, United States
Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP
🇺🇸
Fremont, Nebraska, United States
Prairie Fields Family Medicine/Clinical Research Advantage
🇺🇸
Fremont, Nebraska, United States
Rochester Clinical Research, Inc.
🇺🇸
Rochester, New York, United States
Rapid Medical Research. Inc.
🇺🇸
Cleveland, Ohio, United States
Ohio Pediatric Research Association
🇺🇸
Dayton, Ohio, United States
Coastal Carolina Research Center
🇺🇸
Mt. Pleasant, South Carolina, United States
PMG Research of Bristol
🇺🇸
Bristol, Tennessee, United States
Research Across America
🇺🇸
Katy, Texas, United States
Tekton Research
🇺🇸
Austin, Texas, United States
West Houston Clinical Research Service
🇺🇸
Houston, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸
San Antonio, Texas, United States
J. Lewis Research, Inc. - Foothill Family Clinic
🇺🇸
Salt Lake City, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
🇺🇸
South Jordan, Utah, United States
Advanced Clinical Research
🇺🇸
West Jordan, Utah, United States
PI-Coor Clinical Research, LLC
🇺🇸
Burke, Virginia, United States
Pediatric Research of Charlottesville
🇺🇸
Charlottesville, Virginia, United States
Australian Clinical Research Network
🇦🇺
Maroubra, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺
Westmead, New South Wales, Australia
AusTrials Pty Ltd
🇦🇺
Sherwood, Queensland, Australia
Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics
🇦🇺
North Adelaide, South Australia, Australia
Telethon Institute for Child Health Research
🇦🇺
Subiaco, Australia
Centro De Investigacion Clinica Del Sur
🇨🇱
Temuco, Araucania, Chile
Cesfam Dr. Jose Symon Ojeda
🇨🇱
Conchali, Santiago, Chile
Ordinace praktickeho lekare pro deti a dorost
🇨🇿
Praha 2, Czech Republic
Aarhus Universitetshospital, Skejby
🇩🇰
Aarhus N, Denmark
Eraarst Kersti Veidrik Ou
🇪🇪
Rakvere, Estonia
Tampere Vaccine Research Clinic
🇫🇮
Tampere, Finland
Pori Vaccine Research Clinic
🇫🇮
Pori, Finland
Turku Vaccine Research Clinic
🇫🇮
Turku, Finland
Clinical Trial Center North
🇩🇪
Hamburg, Germany
Clinical Trial Center North GmbH & Co.KG
🇩🇪
Hamburg, Germany
Bernhard Nocht Centre for Clinical Trials (BNCCT)
🇩🇪
Hamburg, Germany
Juliusspital Wuerzburg
🇩🇪
Wuerzburg, Germany
JSC "InMedica"
🇱🇹
Kaunas, Lithuania
Saules Family Medicine Centre
🇱🇹
Kaunas, Lithuania
Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases
🇱🇹
Kaunas, Lithuania
Centro poliklinika, Public Institution
🇱🇹
Vilnius, Lithuania
Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek
🇵🇱
Debica, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
🇵🇱
Lubartow, Poland
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
🇵🇱
Poznan, Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
🇵🇱
Trzebnica, Poland
Instituto Hispalense de Pediatria
🇪🇸
Sevilla, Spain
Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir
🇪🇸
Valencia, Spain
Vaccinenheten Barn- och ungdomsmedicinska kliniken
🇸🇪
Malmo, SE, Sweden
Norrlands Universitetssjukhus, Institution för Pediatrik
🇸🇪
Umeå, Sweden
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸
Salt Lake City, Utah, United States