NCT00808028

A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug In Healthy Adolescents Aged 11 To 18 Years

Completed Phase 2 Results posted Last updated 27 March 2015

What this trial tests

Phase 2 trial testing meningococcal B rLP2086 vaccine. in Meningitis, Meningococcal in 538 participants. Completed in 1 March 2014.

Timeline

1 February 2009

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	538
Start date	1 February 2009
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	27 locations across Australia, Poland, Spain

Drugs / interventions tested

• meningococcal B rLP2086 vaccine.
• meningococcal B rLP2086 vaccine.
• meningococcal B rLP2086 vaccine.
• normal saline (placebo) — full drug profile →

Conditions studied

• Meningitis, Meningococcal — all drugs for Meningitis, Meningococcal →

Sponsor

Pfizer — full company profile →

Who can join

Adults 11 to 18, any sex, with Meningitis, Meningococcal. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial.
   Richmond PC, Marshall HS, Nissen MD, Jiang Q, et al · · 2012 · cited 98× · PMID 22569484 · DOI 10.1016/s1473-3099(12)70087-7
2. Role of factor H binding protein in Neisseria meningitidis virulence and its potential as a vaccine candidate to broadly protect against meningococcal disease.
   McNeil LK, Zagursky RJ, Lin SL, Murphy E, et al · · 2013 · cited 80× · PMID 23699256 · DOI 10.1128/mmbr.00056-12
3. Routinely vaccinating adolescents against meningococcus: targeting transmission & disease.
   Vetter V, Baxter R, Denizer G, Sáfadi MA, et al · · 2016 · cited 53× · PMID 26651380 · DOI 10.1586/14760584.2016.1130628
4. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial.
   Marshall HS, Richmond PC, Beeslaar J, Jiang Q, et al · · 2017 · cited 23× · PMID 27745812 · DOI 10.1016/s1473-3099(16)30314-0
5. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data.
   Beeslaar J, Peyrani P, Absalon J, Maguire J, et al · · 2020 · cited 2× · PMID 32681472 · DOI 10.1007/s40121-020-00322-5