NCT00808028

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2

Geographic Reach
3 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 14, 2015

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

December 12, 2008

Results QC Date

March 27, 2015

Last Update Submit

March 27, 2015

Conditions

Meningitis, Meningococcal

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    Before vaccination 1 up to 1 month after vaccination 3

  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 1

    Vaccination 1 upto 1 Month after vaccination 3

  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 2

    6 month after vaccination 3 up to 48 months

Secondary Outcomes (1)

  • Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level

    1 month before vaccination 1, 1 month after vaccination 2, 3

Other Outcomes (1)

  • Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B

    Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3

Study Arms (4)

1

EXPERIMENTAL

dose level 1 rLP2086 vaccine

Biological: meningococcal B rLP2086 vaccine.

2

EXPERIMENTAL

dose level 2 rLP2086 vaccine

Biological: meningococcal B rLP2086 vaccine.

3

EXPERIMENTAL

dose level 3 rLP2086 vaccine

Biological: meningococcal B rLP2086 vaccine.

4

PLACEBO COMPARATOR

normal saline (placebo)

Other: normal saline (placebo)

Interventions

meningococcal B rLP2086 vaccine.BIOLOGICAL

vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

1
normal saline (placebo)OTHER

vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

4

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment.
  • Negative urine pregnancy test for all female subjects.
  • Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

You may not qualify if:

  • History of any invasive meningococcal disease.
  • A previous anaphylactic or severe vaccine-associated adverse reaction.
  • Any clinically significant chronic disease.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
  • Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Queensland Paediatric Infectious Diseases (QPID) Laboratory

Herston, Queensland, 4029, Australia

Location

Department of Paediatrics, Women's & Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital

Carlton, Victoria, 3053, Australia

Location

Children's Clinical Research Facility, Vaccine Trials Group (VTG),

Subiaco, Western Australia, 6008, Australia

Location

ZOZ w Debicy, Poradnia Chorob Zakaznych

Dębica, 39-200, Poland

Location

SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie

Krakow, 31-202, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,

Krakow, 31-503, Poland

Location

Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi

Lodz, 91-347, Poland

Location

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

Lodz, 91-347, Poland

Location

SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14

Lubartów, 21-100, Poland

Location

Eskulap Sp. z o. o., ul. Weteranow 46

Lublin, 20-044, Poland

Location

SP ZOZ, Poradnia Dziecieca w Grucie

Mełno, 86-330, Poland

Location

NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, 55-120, Poland

Location

Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A

Poznan, 61-734, Poland

Location

NZLA Michalkowice, Jarosz i Partnerzy

Siemianowice Śląskie, 41-03, Poland

Location

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia

Torun, 87-100, Poland

Location

Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej

Trzebnica, 55-100, Poland

Location

Klinika Pediatrii i Chorob Infekcyjnych

Wroclaw, 50-345, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Wroclaw, 50-345, Poland

Location

NZOZ Salmed

Łęczna, 21-010, Poland

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital U. de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital U. 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Complexo Hospitalario Xeral-Cies de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Clinica Virgen del Mar

Almería, 04120, Spain

Location

Hospital General de Cataluna

Barcelona, 08195, Spain

Location

Centro de Salud Nazaret

Valencia, 46024, Spain

Location

Related Publications (4)

  • Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

    PMID: 35164991DERIVED

  • Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.

    PMID: 32681472DERIVED

  • Marshall HS, Richmond PC, Beeslaar J, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Lee SS, Perez JL; 6108A12001 Study Investigators. Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2017 Jan;17(1):58-67. doi: 10.1016/S1473-3099(16)30314-0. Epub 2016 Oct 11.

    PMID: 27745812DERIVED

  • Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garces-Sanchez M, Martinon-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. 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. Lancet Infect Dis. 2012 Aug;12(8):597-607. doi: 10.1016/S1473-3099(12)70087-7. Epub 2012 May 7.

    PMID: 22569484DERIVED

Related Links

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2008

First Posted

December 15, 2008

Study Start

February 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 14, 2015

Results First Posted

April 14, 2015

Record last verified: 2015-03

Locations

PL(16)ES(7)AU(4)