Clinical trial NCT01352845: A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 3301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: 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 the immune response elicited by this vaccine when given to healthy young adults. 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 \>=18 and \<26 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 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.
3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
4. 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.
5. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6. Current chronic use of systemic antibiotics.
7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
8. 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 Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
timeFrame: One month after third bivalent rLP2086 vaccination
measure: Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
timeFrame: Within 7 days after first vaccination
measure: Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
timeFrame: Within 7 days after second vaccination
measure: Percentage of Participants Reporting Pre-specified 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 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 (AE) Within 30 Days After Any Vaccination
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (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 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 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) 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) 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 Reporting at Least 1 Medically Attended Adverse Event 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: Within 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 the third vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
timeFrame: Within 30 minutes after first vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
timeFrame: Within 30 minutes after second vaccination
measure: Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
timeFrame: Within 30 minutes after third vaccination
measure: Number of Days Participants 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 >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: 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: 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: 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: Group 1
timeFrame: One month after second Bivalent rLP2086 vaccination
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: Group 1
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 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
timeFrame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3
measure: hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1
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 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 Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1
timeFrame: One month after third bivalent rLP2086 vaccination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc./Desert Clinical Research, LLC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: Hollyood
country: United States
facility: Broward Research Group
state: Florida
city: Lake Worth
country: United States
facility: Altus Research Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc.
state: Kansas
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Milford
country: United States
facility: Milford Emergency Associates, Inc.
state: Massachusetts
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Bellevue
country: United States
facility: Bellevue Urgent Care
state: Nebraska
city: Bellevue
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Bellevue
country: United States
facility: Pioneer Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research,
state: Nebraska
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Upper St. Clair
country: United States
facility: PEAK Research, LLC
state: Pennsylvania
city: East Greenwich
country: United States
facility: Coastal Medical
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Katy
country: United States
facility: Research Across America
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Bay Roberts
country: Canada
facility: Dr. Calvin Powell Professional Medical Corporation
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology - IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic and Medical Centre
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre
state: Quebec
city: Sainte-Foy, Québec
country: Canada
facility: Clinique Medicale St-Louis Inc.
state: Quebec
city: St-Romuald
country: Canada
facility: Pro-Recherche Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier universitaire de Québec
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Katowice
country: Poland
facility: NZOZ Centrum Medyczne Graniczna Sp. z o.o.
city: Krakow
country: Poland
facility: Specjalistyczna Poradnia Medyczna Przyladek Zdrowia
city: Leczna
country: Poland
facility: NZOZ Salmed s.c.
city: Balenya
country: Spain
facility: CAP Balenya
state: Barcelona
city: Centelles
country: Spain
facility: CAP Centelles
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Vic
country: Spain
facility: CAP El Remei
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Valencia
country: Spain
facility: FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
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.