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

March 27, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

538

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Queensland Paediatric Infectious Diseases (QPID) Laboratory
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Department of Paediatrics, Women's & Children's Hospital
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Royal Children's Hospital
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Children's Clinical Research Facility, Vaccine Trials Group (VTG),
  • Poland
      • Debica, Poland, 39-200
        • ZOZ w Debicy, Poradnia Chorob Zakaznych
      • Krakow, Poland, 31-202
        • SP ZOZ Krakowski Szpital Specjalistyczny im. Jana Pawla II w Krakowie
      • Krakow, Poland, 31-503
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
      • Leczna, Poland, 21-010
        • NZOZ Salmed
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
      • Lubartow, Poland, 21-100
        • SPZOZ w Lubartowie, Oddzial Pediatryczny, ul. Cicha 14
      • Lublin, Poland, 20-044
        • Eskulap Sp. z o. o., ul. Weteranow 46
      • Melno, Poland, 86-330
        • SP ZOZ, Poradnia Dziecieca w Grucie
      • Oborniki Slaskie, Poland, 55-120
        • NZOZ Pratyka Lekarza Rodzinnego Alina Grocka-Wlazlak
      • Poznan, Poland, 61-734
        • Specjalistyczny ZOZ nad Matka i Dzieckiem w Poznaniu Oddzial Obserwacyjno-Zakazny A
      • Siemianowice Slaskie, Poland, 41-03
        • NZLA Michalkowice, Jarosz i Partnerzy
      • Torun, Poland, 87-100
        • NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia
      • Trzebnica, Poland, 55-100
        • Oddzial Dzieciecy Szpital im. Swietej Jadwigi Slaskiej
      • Wroclaw, Poland, 50-345
        • Klinika Pediatrii i Chorob Infekcyjnych
      • Wroclaw, Poland, 50-345
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Spain
      • Almeria, Spain, 04120
        • Clinica Virgen del Mar
      • Barcelona, Spain, 08195
        • Hospital General de Cataluña
      • Madrid, Spain, 28041
        • Hospital U. 12 de Octubre
      • Valencia, Spain, 46024
        • Centro de Salud Nazaret
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital U. de Getafe
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Complexo Hospitalario Xeral-Cies de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
dose level 1 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
EXPERIMENTAL: 2
dose level 2 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
EXPERIMENTAL: 3
dose level 3 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
PLACEBO_COMPARATOR: 4
normal saline (placebo)
Other: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
6 month after vaccination 3 up to 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 month before vaccination 1, 1 month after vaccination 2, 3

Other Outcome Measures

Outcome Measure
Time Frame
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
Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (ESTIMATE)

December 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6108A1-2001
  • B1971005 (OTHER: Alias Study Number)
  • 2008-007789-51 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meningitis, Meningococcal

Clinical Trials on meningococcal B rLP2086 vaccine.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe