Clinical trial NCT01830855: 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
Official title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 3596
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female subject aged \>=10 and \<19 years at the time of enrollment.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. 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.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
5. 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.
6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
7. Current chronic use of systemic antibiotics.
8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Primary outcomes:
measure: 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
timeFrame: One month after third bivalent rLP2086 vaccination
measure: hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine
timeFrame: One month after third bivalent rLP2086 vaccination
measure: Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination
timeFrame: Within 7 Days after first vaccination
measure: Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination
timeFrame: Within 7 Days after second vaccination
measure: Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination
timeFrame: Within 7 Days after third vaccination
measure: Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
timeFrame: Within 7 Days after first vaccination
measure: Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
timeFrame: Within 7 Days after second vaccination
measure: Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
timeFrame: Within 7 Days after third vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination
timeFrame: Within 30 days after first vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination
timeFrame: Within 30 days after second vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination
timeFrame: Within 30 days after third vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
timeFrame: From the first vaccination up to 1 month after the third vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase
timeFrame: From 1 month after third vaccination up to 6 months after the third vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period
timeFrame: From the first vaccination up to 6 month after the third vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination
timeFrame: Within 30 days after first vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination
timeFrame: Within 30 days after second vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination
timeFrame: Within 30 days after third vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase
timeFrame: From the first vaccination up to 1 month after the third vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase
timeFrame: From 1 month after third vaccination up to 6 months after the third vaccination
measure: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period
timeFrame: From the first vaccination up to 6 month after the third vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination
timeFrame: Within 30 days after first vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination
timeFrame: 30 days after second vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination
timeFrame: Within 30 days after third vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
timeFrame: Within 30 Days After any Vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
timeFrame: From the first vaccination up to 1 month after the third vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase
timeFrame: From 1 month after third vaccination up to 6 months after the third vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period
timeFrame: From the first vaccination up to 6 month after the third vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination
timeFrame: Within 30 days after first vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination
timeFrame: Within 30 days after second vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination
timeFrame: Within 30 days after third vaccination
measure: Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase
timeFrame: From the first vaccination up to 1 month after the third vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination
timeFrame: Within 30 minutes after first vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination
timeFrame: Within 30 minutes after second vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination
timeFrame: Within 30 minutes after third vaccination
measure: Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase
timeFrame: From the first vaccination up to 1 month after the third vaccination
Secondary outcomes:
measure: 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
timeFrame: Before first vaccination, 1 month after third vaccination
measure: 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
timeFrame: Before first vaccination, 1 month after third vaccination (Vac)
measure: 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
timeFrame: Before first vaccination, 1 month after third vaccination
measure: 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
timeFrame: Before vaccination 1, 1 Month after Vaccination 2
measure: 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
timeFrame: One month after second Bivalent rLP2086 vaccination
measure: 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
timeFrame: One month after second, third vaccination
measure: 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
timeFrame: Before vaccination (Vac) 1, 1 Month after Vac 2
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
timeFrame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
measure: 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
timeFrame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
measure: 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
timeFrame: One month after third bivalent rLP2086 vaccination
measure: 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
timeFrame: One month after third bivalent rLP2086 vaccination (Vac)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates, PC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatrics
state: Alabama
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners/Clinical Research Advantage, Inc.
state: Colorado
city: Hialeah
country: United States
facility: Aga Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Accelovance
state: Florida
city: Melbourne
country: United States
facility: Accelovance
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research Center
state: Georgia
city: DeKalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: Indianapolis
country: United States
facility: Northpoint Pediatrics
state: Indiana
city: Mishawaka
country: United States
facility: Accelovance, Inc.
state: Indiana
city: Mishawaka
country: United States
facility: Optimal Research, LLC
state: Indiana
city: New Albany
country: United States
facility: Nassim, McMonigle, Mescia & Associates
state: Indiana
city: Augusta
country: United States
facility: Augusta Family Practice
state: Kansas
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Kentucky
city: MT. Sterling
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Mt. Sterling
country: United States
facility: Mt. Sterling Pediatrics
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Eunice
country: United States
facility: David B. Ware, MD
state: Louisiana
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas, LLC
state: Louisiana
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Niles
country: United States
facility: Southwestern Medical Clinic Lakeland HealthCare Affiliate
state: Michigan
city: Saint Paul
country: United States
facility: Allina Health Bandana Square Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Bellevue
country: United States
facility: Bellevue Urgent Care
state: Nebraska
city: Bellevue
country: United States
facility: Pioneer Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, Llc
state: Nebraska
city: Mineola
country: United States
facility: Winthrop Division of Pediatric Infectious Diseases
state: New York
city: Mineola
country: United States
facility: Winthrop Pediatric Associates
state: New York
city: Mineola
country: United States
facility: Winthrop University Pharmacy
state: New York
city: Mineola
country: United States
facility: Winthrop-University Hospital - Clinical Trials Center
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Asheboro
country: United States
facility: Asheboro Research Associates
state: North Carolina
city: Cary
country: United States
facility: Cary Pediatric Center
state: North Carolina
city: Raleigh
country: United States
facility: Capitol Pediatrics & Adolescent Center PLLC
state: North Carolina
city: Cleveland
country: United States
facility: Dr. Shelly David Senders, MD Inc. dba Senders Pediatrics
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatrics, Inc.
state: Ohio
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: PEAK Research, LLC
state: Pennsylvania
city: Kingsport
country: United States
facility: Holston Medical Group - Suite 3B
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group Laboratory
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Lebanon
country: United States
facility: Cumberland Pediatrics Associates
state: Tennessee
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Sudbury
country: Canada
facility: Medicor Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Hartley Garfield Medicine Professional Corporation
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique Medicale St-Louis (recherche) Inc.
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Brandys nad Labem - Stara Boleslav
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci,Centrum ockovani a cestovni mediciny
city: Hradec Kralove
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Odolena Voda
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czech Republic
facility: MUDr. Elena Adamkova
city: Pardubice
country: Czech Republic
facility: Zdravotnicke stredisko Dubina v.o.s.
city: Praha 6
country: Czech Republic
facility: Ordinace praktickeho lekare pro deti a dorost
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Jarvenpaa
country: Finland
facility: Jarvenpaa Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Vantaa
country: Finland
facility: Vantaa East Vaccine Research Clinic
city: Wuerzburg
country: Germany
facility: Central Laboratory and Vaccination Centre, Stiftung Juliusspital
state: Bavaria
city: Bramsche
country: Germany
facility: Kinderarztpraxis Dr. Thomas Adelt
city: Kehl
country: Germany
facility: Gemeinschaftspraxis für Kinder- und Jugendmedizin Dres. Behre, Burgert, Günkel
city: Genova
country: Italy
facility: Dipartimento di Scienze della Salute
city: Milano
country: Italy
facility: UOC di Pediatria 1
city: Ragusa
country: Italy
facility: Azienda Sanitaria Provinciale di Ragusa
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria di Sassari
city: Sassari
country: Italy
facility: Servizio di Igiene e Sanita Pubblica
city: Krakow
country: Poland
facility: oddzial Neuroinfekcji i Neurologii Dzieciecel, Krakowski Szpital Specjalistyczny im.J ana Pawla II
state: Malopolska
city: Krakow
country: Poland
facility: Wojewodzka Poradnia Szczepien Ochronnych
state: Malopolska
city: Debica
country: Poland
facility: Prywatny Gabinet Lekarski dr n med. Jerzy Brzostek
city: Kielczow
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego lek.med. Agata Slawin
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o.
city: Lunlin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap Sp.z o.o. ul.
city: Siemianowice Slaskie
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Wroclaw
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Beata Stecka
city: Southampton
country: United Kingdom
facility: NIHR Wellcome Trust Clinical Research Facility
state: Hampshire
city: Bristol
country: United Kingdom
facility: University of Bristol, Clinical Research and Imaging Centre
city: London
country: United Kingdom
facility: St. George's University of London**
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group, University of Oxford
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.
citation: Beeslaar J, Absalon J, Anderson AS, Eiden JJ, Balmer P, Harris SL, Jones TR, O'Neill RE, Pregaldien JL, Radley D, Maansson R, Ginis J, Srivastava A, Perez JL. MenB-FHbp Vaccine Protects Against Diverse Meningococcal Strains in Adolescents and Young Adults: Post Hoc Analysis of Two Phase 3 Studies. Infect Dis Ther. 2020 Sep;9(3):641-656. doi: 10.1007/s40121-020-00319-0. Epub 2020 Jul 22.
citation: Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.
citation: Ostergaard L, Vesikari T, Absalon J, Beeslaar J, Ward BJ, Senders S, Eiden JJ, Jansen KU, Anderson AS, York LJ, Jones TR, Harris SL, O'Neill R, Radley D, Maansson R, Pregaldien JL, Ginis J, Staerke NB, Perez JL; B1971009 and B1971016 Trial Investigators. A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults. N Engl J Med. 2017 Dec 14;377(24):2349-2362. doi: 10.1056/NEJMoa1614474.