A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
- Conditions
- Healthy
- Interventions
- Biological: rLP2086Other: Placebo
- Registration Number
- NCT01352845
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3301
- Male or female subject aged >=18 and <26 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 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 rLP2086 - Control Placebo Steril normal saline solution
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase From the first vaccination up to 1 month after the third vaccination 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 One month after third bivalent rLP2086 vaccination Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination Within 7 days after second 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 (AE) Within 30 Days After Third Vaccination Within 30 days after third vaccination 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 Medically Attended AE Within 30 Days After First Vaccination Within 30 days after first vaccination Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination Within 30 days after second 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 the third vaccination Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination Within 7 days after third 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) 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 Within 30 Days After Second Vaccination Within 30 days after second 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 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination Within 30 days after any 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 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) Throughout the Study Period From the first vaccination up to 6 month after the third 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 Vaccination Phase From the first vaccination up to 1 month after the third vaccination Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period From the first vaccination up to 6 month after the third vaccination Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination Within 30 minutes after first vaccination Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination Within 30 minutes after second vaccination Number of Days Participants 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 Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination Within 7 days after first vaccination Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination Within 7 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 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 Within 30 Days After First Vaccination Within 30 days after first 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 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 Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination Within 30 minutes 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 Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination Within 7 days after second vaccination Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination Within 30 days after any vaccination
- Secondary Outcome Measures
Name Time Method 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 Before first vaccination, 1 month after third 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: Group 1 Before vaccination 1, 1 Month after Vaccination 2 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 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 endpoint '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'.
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 Before Vaccination (Vac) 1, 1 Month after Vac 2, 3 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 One month after third bivalent rLP2086 vaccination hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1 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 First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1 Before first vaccination, 1 month after third vaccination (Vac) 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 Before first vaccination, 1 month after third vaccination 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 One month after second Bivalent rLP2086 vaccination 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 One month after third bivalent rLP2086 vaccination
Trial Locations
- Locations (54)
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Clinical Research Advantage, Inc./Desert Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
Anaheim Clinical Trials LLC
🇺🇸Anaheim, California, United States
eStudySite
🇺🇸La Mesa, California, United States
Broward Research Group
🇺🇸Hollyood, Florida, United States
Altus Research Inc.
🇺🇸Lake Worth, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Johnson County Clin-Trials, Inc.
🇺🇸Lenexa, Kansas, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Pioneer Clinical Research, LLC
🇺🇸Bellevue, Nebraska, United States
Meridian Clinical Research,
🇺🇸Omaha, Nebraska, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
PEAK Research, LLC
🇺🇸Upper St. Clair, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Research Across America
🇺🇸Katy, Texas, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Dr. Calvin Powell Professional Medical Corporation
🇨🇦Bay Roberts, Newfoundland and Labrador, Canada
Canadian Center for Vaccinology - IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Milestone Research
🇨🇦London, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
🇨🇦Sarnia, Ontario, Canada
Pro-Recherche Inc.
🇨🇦St-Romuald, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre
🇨🇦Pierrefonds, Quebec, Canada
Aarhus Universitetshospital Skejby
🇩🇰Aarhus N, Denmark
Kokkola Vaccine Research Clinic
🇫🇮Kokkola, Finland
FOM (Fundacion Oftalmologica del Mediterraneo) - FISABIO
🇪🇸Valencia, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC
🇺🇸Tempe, Arizona, United States
Benchmark Research
🇺🇸Metairie, Louisiana, United States
Milford Emergency Associates, Inc.
🇺🇸Milford, Massachusetts, United States
Bellevue Urgent Care
🇺🇸Bellevue, Nebraska, United States
Devonshire Clinical Research Inc.
🇨🇦Woodstock, Ontario, Canada
Clinique Medicale St-Louis Inc.
🇨🇦Sainte-Foy, Québec, Quebec, Canada
Centre hospitalier universitaire de Québec
🇨🇦Quebec, Canada
Espoo Vaccine Research Clinic
🇫🇮Espoo, Finland
Helsinki South Vaccine Research Clinic
🇫🇮Helsinki, Finland
Seinäjoki Vaccine Research Clinic
🇫🇮Seinäjoki, Finland
NZOZ Centrum Medyczne Graniczna Sp. z o.o.
🇵🇱Katowice, Poland
Specjalistyczna Poradnia Medyczna Przyladek Zdrowia
🇵🇱Krakow, Poland
NZOZ Salmed s.c.
🇵🇱Leczna, Poland
CAP Balenya
🇪🇸Balenya, Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
CAP Centelles
🇪🇸Centelles, Barcelona, Spain
CAP El Remei
🇪🇸Vic, Barcelona, Spain
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Coastal Medical
🇺🇸East Greenwich, Rhode Island, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States