A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
- Conditions
- Meningitis, Meningococcal
- Registration Number
- NCT01352793
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5715
- Healthy subjects aged 10 to 25 years.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study Vaccination 1 up to 6 months after Vaccination 3 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.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 Within 30 days after Vaccination 1 A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 Within 30 days after Vaccination 2 A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 Within 30 days after Vaccination 3 A medically attended AE was defined as a non-serious AE that required medical attention.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination Within 30 minutes after Vaccination 1, 2, 3 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.
Number of Days Participant Missed School or Work Due to Adverse Events (AEs) Vaccination 1 up to 1 month after Vaccination 3 Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods 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) 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.
Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods 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) 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.
Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods 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) A medically attended AE was defined as a non-serious AE that required medical attention.
Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) 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.
Trial Locations
- Locations (77)
Accelovance,Inc.
🇺🇸Mishawaka, Indiana, United States
Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC
🇺🇸Tempe, Arizona, United States
Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Cassidy Medical Group/Clinical Research Advantage
🇺🇸Vista, California, United States
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address
🇺🇸Tempe, Arizona, United States
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
Accelovance. Inc
🇺🇸San Diego, California, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Scroll for more (67 remaining)Accelovance,Inc.🇺🇸Mishawaka, Indiana, United States