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A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Primary Purpose

Meningitis, Meningococcal

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
meningococcal B rLP2086 vaccine.
meningococcal B rLP2086 vaccine.
meningococcal B rLP2086 vaccine.
normal saline (placebo)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Queensland Paediatric Infectious Diseases (QPID) Laboratory
  • Department of Paediatrics, Women's & Children's Hospital
  • Royal Children's Hospital
  • Children's Clinical Research Facility, Vaccine Trials Group (VTG),
  • ZOZ w Debicy, Poradnia Chorob Zakaznych
  • SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
  • NZOZ Salmed
  • Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
  • SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
  • Eskulap Sp. z o. o., ul. Weteranow 46
  • SP ZOZ, Poradnia Dziecieca w Grucie
  • NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
  • Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
  • NZLA Michalkowice, Jarosz i Partnerzy
  • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
  • Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
  • Klinika Pediatrii i Chorob Infekcyjnych
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Hospital Clinico Universitario de Santiago de Compostela
  • Hospital U. de Getafe
  • Complexo Hospitalario Xeral-Cies de Vigo
  • Clinica Virgen del Mar
  • Hospital General de Cataluna
  • Hospital U. 12 de Octubre
  • Centro de Salud Nazaret

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

dose level 1 rLP2086 vaccine

dose level 2 rLP2086 vaccine

dose level 3 rLP2086 vaccine

normal saline (placebo)

Outcomes

Primary Outcome Measures

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
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
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2008
Last Updated
March 27, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00808028
Brief Title
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
538 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
dose level 1 rLP2086 vaccine
Arm Title
2
Arm Type
Experimental
Arm Description
dose level 2 rLP2086 vaccine
Arm Title
3
Arm Type
Experimental
Arm Description
dose level 3 rLP2086 vaccine
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
normal saline (placebo)
Intervention Type
Biological
Intervention Name(s)
meningococcal B rLP2086 vaccine.
Intervention Description
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention Type
Biological
Intervention Name(s)
meningococcal B rLP2086 vaccine.
Intervention Description
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention Type
Biological
Intervention Name(s)
meningococcal B rLP2086 vaccine.
Intervention Description
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention Type
Other
Intervention Name(s)
normal saline (placebo)
Intervention Description
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Primary Outcome Measure Information:
Title
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
Title
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
Title
Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Time Frame
Vaccination 1 upto 1 Month after vaccination 3
Title
Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Time Frame
6 month after vaccination 3 up to 48 months
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
Time Frame
Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Queensland Paediatric Infectious Diseases (QPID) Laboratory
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Department of Paediatrics, Women's & Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Children's Hospital
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Children's Clinical Research Facility, Vaccine Trials Group (VTG),
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
ZOZ w Debicy, Poradnia Chorob Zakaznych
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Facility Name
NZOZ Salmed
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
City
Lubartow
ZIP/Postal Code
21-100
Country
Poland
Facility Name
Eskulap Sp. z o. o., ul. Weteranow 46
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
SP ZOZ, Poradnia Dziecieca w Grucie
City
Melno
ZIP/Postal Code
86-330
Country
Poland
Facility Name
NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
City
Oborniki Slaskie
ZIP/Postal Code
55-120
Country
Poland
Facility Name
Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
City
Poznan
ZIP/Postal Code
61-734
Country
Poland
Facility Name
NZLA Michalkowice, Jarosz i Partnerzy
City
Siemianowice Slaskie
ZIP/Postal Code
41-03
Country
Poland
Facility Name
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Klinika Pediatrii i Chorob Infekcyjnych
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital U. de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Complexo Hospitalario Xeral-Cies de Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Clinica Virgen del Mar
City
Almeria
ZIP/Postal Code
04120
Country
Spain
Facility Name
Hospital General de Cataluna
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital U. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro de Salud Nazaret
City
Valencia
ZIP/Postal Code
46024
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35164991
Citation
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.
Results Reference
derived
PubMed Identifier
32681472
Citation
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.
Results Reference
derived
PubMed Identifier
27745812
Citation
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.
Results Reference
derived
PubMed Identifier
22569484
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6108A1-2001&StudyName=A%20Study%20Evaluating%20Safety%20And%20Immunogenicity%20Of%20Meningococcal%20B%20Rlp2086%20Vaccine%20In%20Adolescents
Description
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A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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