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

NCT01352793 | Completed Phase 3 Results DMC

• 3 other identifiers: B19710142009-015198-116108A1-3003
• Study Type: interventional
• Target: 5,715
• Locations: 11 countries
• Sites: 84

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.

Conditions

Meningitis, Meningococcal

Keywords

phase 3 safety study; 5700 healthy subjects; 3 vaccine doses at month 0; 2; and 6; control HAV/saline/HAV

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study

  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.

  Vaccination 1 up to 6 months after Vaccination 3

• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1

  A medically attended AE was defined as a non-serious AE that required medical attention.

  Within 30 days after Vaccination 1

• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2

  A medically attended AE was defined as a non-serious AE that required medical attention.

  Within 30 days after Vaccination 2

• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3

  A medically attended AE was defined as a non-serious AE that required medical attention.

  Within 30 days after Vaccination 3

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination

  Within 30 minutes after Vaccination 1, 2, 3

Study Arms (2)

rLP2086 vaccine

EXPERIMENTAL

rLP2086 vaccine

Biological: rLP2086 vaccine

control

OTHER

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

Biological: control

Interventions

rLP2086 vaccine BIOLOGICAL

120 mcg, 3 doses, at month 0, 2, and 6.

rLP2086 vaccine

control BIOLOGICAL

HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.

control

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects aged 10 to 25 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (86)

Accelovance,Inc.

Huntsville, Alabama, 35802, United States

Location

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC

Chandler, Arizona, 85224, United States

Location

Cassidy Medical Group/Clinical Research Advantage

Tempe, Arizona, 85282, United States

Location

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Tempe, Arizona, 85282, United States

Location

Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address

Tempe, Arizona, 85282, United States

Location

Harrisburg Family Medical Center

Harrisburg, Arkansas, 72432, United States

Location

Accelovance. Inc

San Diego, California, 92108, United States

Location

Benchmark Research

San Francisco, California, 94102, United States

Location

Cassidy Medical Group/Clinical Research Advantage

Vista, California, 92083, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Accelovance

Melbourne, Florida, 32935, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Accelovance,Inc.

Mishawaka, Indiana, 46545, United States

Location

Clinical Research Advantage,Inc/Ridge Family Practice

Council Bluffs, Iowa, 51503, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP

Fremont, Nebraska, 68025, United States

Location

Prairie Fields Family Medicine/Clinical Research Advantage

Fremont, Nebraska, 68025, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Rapid Medical Research. Inc.

Cleveland, Ohio, 44122, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

West Houston Clinical Research Service

Houston, Texas, 77055, United States

Location

Research Across America

Katy, Texas, 77450, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

J. Lewis Research, Inc. - Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

J. Lewis Research, Inc. - Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Pediatric Research of Charlottesville

Charlottesville, Virginia, 22902, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

AusTrials Pty Ltd

Sherwood, Queensland, 4075, Australia

Location

Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics

North Adelaide, South Australia, 5006, Australia

Location

Telethon Institute for Child Health Research

Subiaco, 6008, Australia

Location

Centro De Investigacion Clinica Del Sur

Temuco, Región de la Araucanía, 4781156, Chile

Location

Cesfam Dr. Jose Symon Ojeda

Conchalí, Santiago Metropolitan, 8550442, Chile

Location

Hospital Clinico de la Pontificia Universidad Catolica de Chile/

Santiago, Santiago Metropolitan, 8330034, Chile

Location

Centro de Estudios de Vacunas, CESFAM Gabriela Mistral

Santiago, Santiago Metropolitan, 886000, Chile

Location

Hospital Luis Calvo Mackenna

Santiago, 7500539, Chile

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 37701, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Pilsen, 30138, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Prague, 120 00, Czechia

Location

Prakticky Lekar Pro Deti a Mladez

Týnec nad Sázavou, 257 41, Czechia

Location

Aarhus Universitetshospital, Skejby

Aarhus N, 8200, Denmark

Location

Eraarst Kersti Veidrik Ou

Rakvere, 44316, Estonia

Location

Innomedica OU

Tallinn, 10117, Estonia

Location

Merekivi Perearstid OU

Tallinn, 10617, Estonia

Location

Merelahe Family Doctors Centre

Tallinn, 10617, Estonia

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Clinical Trial Center North

Hamburg, 20246, Germany

Location

Clinical Trial Center North GmbH & Co.KG

Hamburg, 20251, Germany

Location

Bernhard Nocht Centre for Clinical Trials (BNCCT)

Hamburg, 20359, Germany

Location

Juliusspital Wuerzburg

Würzburg, 97070, Germany

Location

JSC "InMedica"

Kaunas, 48259, Lithuania

Location

Saules Family Medicine Centre

Kaunas, LT-49449, Lithuania

Location

Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases

Kaunas, LT47116, Lithuania

Location

LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE

Kaunas, LT50009, Lithuania

Location

Centro poliklinika, Public Institution

Vilnius, LT01117, Lithuania

Location

Krakowski Szpital Specjalistyczny im Jana Pawla II

Krakow, Poland, 31-202, Poland

Location

Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek

Dębica, 39-200, Poland

Location

Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, 31-302, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny

Lubartów, 21-100, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, 55-120, Poland

Location

Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu

Poznan, 61-709, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, 41-103, Poland

Location

NZOZ Nasz Lekarz

Torun, 87-100, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

Trzebnica, 55-100, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

Wroclaw, 50-345, Poland

Location

Instituto Hispalense de Pediatria

Seville, Sevilla, 41014, Spain

Location

Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir

Valencia, Valencia, 46001, Spain

Location

Vaccinenheten Barn- och ungdomsmedicinska kliniken

Malmo, SE, 205 02, Sweden

Location

Norrlands Universitetssjukhus, Institution för Pediatrik

Umeå, 90185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35164991 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 11, 2015
• Results First Posted: March 11, 2015

Record last verified: 2015-02

Locations

LI (5); US (39); CL (5); FI (3); ES (4); AU (5); DE (4); DK (1); PL (10); SE (2); CZ (6)