A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
NCT01352845 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3301
Last updated 2016-02-23
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.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
rLP2086
0.5 mL dose, given at 0, 2 and 6 months
- OTHER
-
Placebo
0.5 mL dose, given at 0, 2 and 6 months
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2015-02-28
- Completion
- 2015-02-28
Countries
- United States
- Canada
- Denmark
- Finland
- Poland
- Spain
Study Locations
More Related Trials
-
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
NCT03135834 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
NCT00808028 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
NCT00387725 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
NCT00879814 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
NCT02531698 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
NCT04318548 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
NCT00387569 ·Status: COMPLETED ·Phase: PHASE1
-
Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose
NCT01543087 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
NCT00297687 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
NCT01461980 ·Status: COMPLETED ·Phase: PHASE2
-
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
NCT01768117 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
NCT01154088 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
NCT00297817 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
NCT00126945 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
NCT01911221 ·Status: COMPLETED ·Phase: PHASE3
-
Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers
NCT06284915 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
NCT01367158 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
NCT01165242 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
NCT00471081 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612
NCT00390143 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
NCT00196950 ·Status: COMPLETED ·Phase: PHASE2
-
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
NCT00728260 ·Status: COMPLETED
-
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
NCT01272180 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
NCT07135986 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3