Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Phase 2
Completed
- Conditions
- Healthy
- Registration Number
- NCT00387725
- Lead Sponsor
- Pfizer
- Brief Summary
Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
Inclusion Criteria
- Aged 8 to 14 years at the time of enrollment.
- Healthy male or female subjects
- Negative urine pregnancy test for female subjects
Exclusion Criteria
Exclusion Criteria
- Prior vaccination with a meningococcal B vaccine
- Prior meningococcal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 1 month after Dose 3 Percentage of Participants With at Least One Adverse Event (AE) Dose 1 up to 1 month after Dose 3 Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 1 month after Dose 2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Herston, Queensland, Australia
Princess Margaret Hospital for Children
🇦🇺Subiaco, Western Australia, Australia
Sir Albert Sakzewski Virus Research Centre (SASVRC)
🇦🇺Herston, Australia
Women's & Children's Hospital
🇦🇺North Adelaide, Australia
The Telethon Institute for Child Health Research
🇦🇺Subiaco, Australia
National Centre for Immunisation
🇦🇺Westmead, Australia
Department of Paediatrics and Child Health
🇦🇺Woden, Australia
Sydney Children's Hospital🇦🇺Randwick, New South Wales, Australia