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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
538

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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