Meningitis, Meningococcal Clinical Trial
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
| Verified date | February 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 5715 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 10 Years to 25 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Australian Clinical Research Network | Maroubra | New South Wales |
| Australia | Vaccinology and Immunology Research Trials Unit (VIRTU), Discipline of Paediatrics | North Adelaide | South Australia |
| Australia | AusTrials Pty Ltd | Sherwood | Queensland |
| Australia | Telethon Institute for Child Health Research | Subiaco | |
| Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
| Chile | Cesfam Dr. Jose Symon Ojeda | Conchali | Santiago |
| Chile | Centro de Estudios de Vacunas, CESFAM Gabriela Mistral | Santiago | Region Metropolitana |
| Chile | Hospital Clinico de la Pontificia Universidad Catolica de Chile/ | Santiago | Region Metropolitana |
| Chile | Hospital Luis Calvo Mackenna | Santiago | |
| Chile | Centro De Investigacion Clinica Del Sur | Temuco | Araucania |
| Czech Republic | Ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | |
| Czech Republic | Samostatna ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | |
| Czech Republic | Samostatna ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec | |
| Czech Republic | Ordinace praktickeho lekare pro deti a dorost | Plzen | |
| Czech Republic | Ordinace praktickeho lekare pro deti a dorost | Praha 2 | |
| Czech Republic | Prakticky Lekar Pro Deti a Mladez | Tynec nad Sazavou | |
| Denmark | Aarhus Universitetshospital, Skejby | Aarhus N | |
| Estonia | Eraarst Kersti Veidrik Ou | Rakvere | |
| Estonia | Innomedica OU | Tallinn | |
| Estonia | Merekivi Perearstid OU | Tallinn | |
| Estonia | Merelahe Family Doctors Centre | Tallinn | |
| Finland | Pori Vaccine Research Clinic | Pori | |
| Finland | Tampere Vaccine Research Clinic | Tampere | |
| Finland | Turku Vaccine Research Clinic | Turku | |
| Germany | Bernhard Nocht Centre for Clinical Trials (BNCCT) | Hamburg | |
| Germany | Clinical Trial Center North | Hamburg | |
| Germany | Clinical Trial Center North GmbH & Co.KG | Hamburg | |
| Germany | Juliusspital Wuerzburg | Wuerzburg | |
| Lithuania | JSC "InMedica" | Kaunas | |
| Lithuania | Kaunas Clinical Hospital, Public Institution, Clinic of Infectious Diseases | Kaunas | |
| Lithuania | LITHUANIAN HEALTH SCIENCE UNIVERSITY HOSPITAL, CLINIC of FAMILY MEDICINE | Kaunas | |
| Lithuania | Saules Family Medicine Centre | Kaunas | |
| Lithuania | Centro poliklinika, Public Institution | Vilnius | |
| Poland | Prywatny Gabinet Lekarski Dr.n.med.Jerzy Brzostek | Debica | |
| Poland | Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska | Krakow | |
| Poland | Krakowski Szpital Specjalistyczny im Jana Pawla II | Krakow | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny | Lubartow | |
| Poland | NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak | Oborniki Slaskie | |
| Poland | Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu | Poznan | |
| Poland | NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska | Siemianowice Slaskie | |
| Poland | NZOZ Nasz Lekarz | Torun | |
| Poland | Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny | Trzebnica | |
| Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu | Wroclaw | |
| Spain | Instituto Hispalense de Pediatria | Sevilla | |
| Spain | Clinicas Universitarias. Universidad Catolica de Valencia San Vicente Martir | Valencia | |
| Sweden | Vaccinenheten Barn- och ungdomsmedicinska kliniken | Malmo | SE |
| Sweden | Norrlands Universitetssjukhus, Institution för Pediatrik | Umeå | |
| United States | Benchmark Research | Austin | Texas |
| United States | Tekton Research | Austin | Texas |
| United States | Kentucky Pediatric/Adult Research | Bardstown | Kentucky |
| United States | PMG Research of Bristol | Bristol | Tennessee |
| United States | PI-Coor Clinical Research, LLC | Burke | Virginia |
| United States | Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC | Chandler | Arizona |
| United States | Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC | Chandler | Arizona |
| United States | Pediatric Research of Charlottesville | Charlottesville | Virginia |
| United States | Rapid Medical Research. Inc. | Cleveland | Ohio |
| United States | Clinical Research Advantage,Inc/Ridge Family Practice | Council Bluffs | Iowa |
| United States | Research Across America | Dallas | Texas |
| United States | Ohio Pediatric Research Association | Dayton | Ohio |
| United States | Avail Clinical Research, LLC | DeLand | Florida |
| United States | Benchmark Research | Fort Worth | Texas |
| 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 | Harrisburg Family Medical Center | Harrisburg | Arkansas |
| United States | West Houston Clinical Research Service | Houston | Texas |
| United States | Accelovance,Inc. | Huntsville | Alabama |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | Research Across America | Katy | Texas |
| United States | Accelovance | Melbourne | Florida |
| United States | Optimal Research, LLC | Melbourne | Florida |
| United States | Accelovance,Inc. | Mishawaka | Indiana |
| United States | Coastal Carolina Research Center | Mt. Pleasant | South Carolina |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| United States | J. Lewis Research, Inc. - Foothill Family Clinic | Salt Lake City | Utah |
| United States | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah |
| United States | Jean Brown Research | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | Accelovance. Inc | San Diego | California |
| United States | Benchmark Research | San Francisco | California |
| United States | J. Lewis Research, Inc. - Jordan River Family Medicine | South Jordan | Utah |
| United States | Miami Research Associates | South Miami | Florida |
| United States | Cassidy Medical Group/Clinical Research Advantage | Tempe | Arizona |
| United States | 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 | Cassidy Medical Group/Clinical Research Advantage | Vista | California |
| United States | Advanced Clinical Research | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Chile, Czech Republic, Denmark, Estonia, Finland, Germany, Lithuania, Poland, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | 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. | 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) | Yes |
| Secondary | Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | A medically attended AE was defined as a non-serious AE that required medical attention. | 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) | Yes |
| Secondary | Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | 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. | 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) | Yes |
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | 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. | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) | Yes |
| Secondary | Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | 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. | Within 30 minutes after Vaccination 1, 2, 3 | Yes |
| Secondary | Number of Days Participant Missed School or Work Due to Adverse Events (AEs) | Vaccination 1 up to 1 month after Vaccination 3 | Yes |
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