A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
- Conditions
- Meningococcal Vaccine
- Interventions
- Biological: rLP2086Biological: Havrix (HAV)Biological: Saline
- Registration Number
- NCT01830855
- Lead Sponsor
- Pfizer
- Brief Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3596
- Male or female subject aged >=10 and <19 years at the time of enrollment.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
- Previous vaccination with any meningococcal serogroup B vaccine.
- Subjects who have received prior HAV vaccination.
- Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rLP2086 lot 1 rLP2086 - rLP2086 lot 2 rLP2086 - Control Havrix (HAV) Havrix (HAV) and Saline rLP2086 lot 3 rLP2086 - Control Saline Havrix (HAV) and Saline
- Primary Outcome Measures
Name Time Method Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1 One month after third bivalent rLP2086 vaccination Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine One month after third bivalent rLP2086 vaccination Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination Within 7 Days after first vaccination Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination Within 7 Days after second vaccination Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination Within 7 Days after third vaccination Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination Within 7 Days after first vaccination Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination Within 7 Days after second vaccination Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination Within 30 days after first vaccination Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination Within 30 days after second vaccination Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination Within 30 days after third vaccination Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase From 1 month after third vaccination up to 6 months after the third vaccination Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period From the first vaccination up to 6 month after the third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination Within 30 days after first vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination Within 30 days after any vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period From the first vaccination up to 6 month after the third vaccination Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination Within 7 Days after third vaccination Here, N signifies participants with known values reporting specific characteristic.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination Within 30 days after first vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination Within 30 days after second vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination Within 30 days after third vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination Within 30 days after any vaccination Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination Within 30 days after third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination Within 30 Days After any Vaccination Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination Within 30 days after third vaccination Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase From 1 month after third vaccination up to 6 months after the third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination 30 days after second vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase From 1 month after third vaccination up to 6 months after the third vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period From the first vaccination up to 6 month after the third vaccination Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination Within 30 days after first vaccination Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination Within 30 days after second vaccination Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination Within 30 Days after any vaccination Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination Within 30 minutes after second vaccination Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination Within 30 minutes after third vaccination Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination Within 30 minutes after first vaccination
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination One month after second, third vaccination hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination Before vaccination (Vac) 1, 1 Month after Vac 2 Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 Before first vaccination, 1 month after third vaccination (Vac) Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1 Before first vaccination, 1 month after third vaccination Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1 One month after second Bivalent rLP2086 vaccination Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.
hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1 Before first vaccination, 1 month after third vaccination Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination One month after third bivalent rLP2086 vaccination Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1 Before vaccination 1, 1 Month after Vaccination 2 Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.
Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination One month after third bivalent rLP2086 vaccination (Vac)
Trial Locations
- Locations (91)
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Southeastern Pediatrics
🇺🇸Dothan, Alabama, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Colorado Springs Health Partners/Clinical Research Advantage, Inc.
🇺🇸Colorado Springs, Colorado, United States
Aga Clinical Trials
🇺🇸Hialeah, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Accelovance
🇺🇸Melbourne, Florida, United States
North Georgia Clinical Research Center
🇺🇸Dalton, Georgia, United States
Northern Illinois Research Associates
🇺🇸DeKalb, Illinois, United States
Accelovance, Inc.
🇺🇸Mishawaka, Indiana, United States
Optimal Research, LLC
🇺🇸Mishawaka, Indiana, United States
Nassim, McMonigle, Mescia & Associates
🇺🇸New Albany, Indiana, United States
Augusta Family Practice
🇺🇸Augusta, Kansas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Central Kentucky Research Associates, Inc.
🇺🇸MT. Sterling, Kentucky, United States
Mt. Sterling Pediatrics
🇺🇸Mt. Sterling, Kentucky, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
David B. Ware, MD
🇺🇸Eunice, Louisiana, United States
ACC Pediatric Research
🇺🇸Haughton, Louisiana, United States
Allina Health Bandana Square Clinic
🇺🇸Saint Paul, Minnesota, United States
Benchmark Research
🇺🇸Metairie, Louisiana, United States
Southwestern Medical Clinic Lakeland HealthCare Affiliate
🇺🇸Niles, Michigan, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Bellevue Urgent Care
🇺🇸Bellevue, Nebraska, United States
Winthrop Division of Pediatric Infectious Diseases
🇺🇸Mineola, New York, United States
Winthrop Pediatric Associates
🇺🇸Mineola, New York, United States
Winthrop-University Hospital - Clinical Trials Center
🇺🇸Mineola, New York, United States
Winthrop University Pharmacy
🇺🇸Mineola, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Asheboro Research Associates
🇺🇸Asheboro, North Carolina, United States
Cary Pediatric Center
🇺🇸Cary, North Carolina, United States
Capitol Pediatrics & Adolescent Center PLLC
🇺🇸Raleigh, North Carolina, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Ohio Pediatrics, Inc.
🇺🇸Dayton, Ohio, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Uniontown, Pennsylvania, United States
PEAK Research, LLC
🇺🇸Upper St. Clair, Pennsylvania, United States
Liberty Family Practice
🇺🇸Erie, Pennsylvania, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States
Pediatric Research of Charlottesville
🇺🇸Charlottesville, Virginia, United States
Advanced Pediatrics
🇺🇸Vienna, Virginia, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Medicor Research Inc.
🇨🇦Sudbury, Ontario, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Dr. Hartley Garfield Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Ordinace praktickeho lekare pro deti a dorost
🇨🇿Praha 6, Czech Republic
ALPHA Recherche Clinique
🇨🇦Quebec, Canada
Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny
🇨🇿Hradec Kralove, Czech Republic
Clinique Medicale St-Louis (recherche) Inc.
🇨🇦Quebec, Canada
MUDr. Elena Adamkova
🇨🇿Pardubice, Czech Republic
Helsinki East Vaccine Research Clinic
🇫🇮Helsinki, Finland
Zdravotnicke stredisko Dubina v.o.s.
🇨🇿Pardubice, Czech Republic
Jarvenpaa Vaccine Research Clinic
🇫🇮Jarvenpaa, Finland
Oulu Vaccine Research Clinic
🇫🇮Oulu, Finland
Vantaa East Vaccine Research Clinic
🇫🇮Vantaa, Finland
Central Laboratory and Vaccination Centre, Stiftung Juliusspital
🇩🇪Wuerzburg, Bavaria, Germany
Kinderarztpraxis Dr. Thomas Adelt
🇩🇪Bramsche, Germany
Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel
🇩🇪Kehl, Germany
Wojewodzka Poradnia Szczepien Ochronnych
🇵🇱Krakow, Malopolska, Poland
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
🇵🇱Siemianowice Slaskie, Poland
St. George's University of London**
🇬🇧London, United Kingdom
University of Bristol, Clinical Research and Imaging Centre
🇬🇧Bristol, United Kingdom
Oxford Vaccine Group, University of Oxford
🇬🇧Oxford, United Kingdom
Dipartimento di Scienze della Salute
🇮🇹Genova, Italy
UOC di Pediatria 1
🇮🇹Milano, Italy
Azienda Sanitaria Provinciale di Ragusa
🇮🇹Ragusa, Italy
Azienda Ospedaliero Universitaria di Sassari
🇮🇹Sassari, Italy
Servizio di Igiene e Sanita Pubblica
🇮🇹Sassari, Italy
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
Horizon Research Group of Opelousas, LLC
🇺🇸Eunice, Louisiana, United States
oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II
🇵🇱Krakow, Malopolska, Poland
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Holston Medical Group - Suite 3B
🇺🇸Kingsport, Tennessee, United States
Cumberland Pediatrics Associates
🇺🇸Lebanon, Tennessee, United States
Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek
🇵🇱Debica, Poland
NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin
🇵🇱Kielczow, Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o.
🇵🇱Lublin, Poland
Holston Medical Group Laboratory
🇺🇸Kingsport, Tennessee, United States
Pioneer Clinical Research, LLC
🇺🇸Bellevue, Nebraska, United States
NZOZ Praktyka Lekarza Rodzinnego Beata Stecka
🇵🇱Wroclaw, Poland
NIHR Wellcome Trust Clinical Research Facility
🇬🇧Southampton, Hampshire, United Kingdom
NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul.
🇵🇱Lunlin, Poland
Birmingham Pediatric Associates, PC
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
California Research Foundation
🇺🇸San Diego, California, United States
Northpoint Pediatrics
🇺🇸Indianapolis, Indiana, United States
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research, Llc
🇺🇸Omaha, Nebraska, United States
Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
🇺🇸Cleveland, Ohio, United States