The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
538
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Time frame: Before vaccination 1 up to 1 month after vaccination 2
Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Time frame: Before vaccination 1 up to 1 month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Time frame: Vaccination 1 upto 1 Month after vaccination 3
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Time frame: 6 month after vaccination 3 up to 48 months
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Time frame: 1 month before vaccination 1, 1 month after vaccination 2, 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, Australia
Department of Paediatrics, Women's & Children's Hospital
North Adelaide, South Australia, Australia
Royal Children's Hospital
Carlton, Victoria, Australia
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
Subiaco, Western Australia, Australia
ZOZ w Debicy, Poradnia Chorob Zakaznych
Dębica, Poland
SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
Krakow, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
Krakow, Poland
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lodz, Poland
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, Poland
SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
Lubartów, Poland
...and 17 more locations