A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

October 26, 2022 updated by: Pfizer

A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

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.
1714

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

  • Czechia
      • Brandys nad Labem - Stara Boleslav, Czechia, 25001
        • Ordinace praktického lékaře pro děti a dorost
      • Chlumec nad Cidlinou, Czechia, 50351
        • Ordinace praktického lékaře pro děti a dorost
      • Holice, Czechia, 53401
        • Ordinace praktického lékaře pro děti a dorost
      • Hradec Kralove, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Hradec Kralove, Czechia, 50004
        • Ordinace praktického lékaře pro děti a dorost
      • Hradec Kralove, Czechia, 50002
        • Ordinace praktického lékaře pro děti a dorost
      • Jindrichuv Hradec, Czechia, 37701
        • Ordinace praktického lékaře pro děti a dorost
      • Odolena Voda, Czechia, 25070
        • Ordinace praktického lékaře pro děti a dorost
      • Pardubice, Czechia, 53002
        • Ordinace praktického lékaře pro děti a dorost
      • Pardubice, Czechia, 53012
        • Ordinace praktického lékaře pro děti a dorost
      • Praha - Horni Pocernice, Czechia, 19300
        • Ordinace praktického lékaře pro děti a dorost
      • Praha - Nusle, Czechia, 14000
        • Ordinace praktického lékaře pro děti a dorost
      • Praha 1, Czechia, 11000
        • Ordinace praktického lékaře pro děti a dorost
      • Praha 6, Czechia, 16000
        • Ordinace praktického lékaře pro děti a dorost
      • Praha 6 - Petriny, Czechia, 16200
        • Ordinace praktického lékaře pro děti a dorost
      • Sezemice, Czechia, 53304
        • Ordinace praktického lékaře pro děti a dorost
  • Denmark
      • Aarhus N, Denmark, 8200
        • Infektionsmedicinsk Afdeling Q
  • Finland
      • Espoo, Finland, 02230
        • Espoo Vaccine Research Clinic
      • Helsinki, Finland, 00100
        • Helsinki South Vaccine Research Clinic
      • Helsinki, Finland, 00930
        • Helsinki East Vaccine Research Clinic
      • Järvenpää, Finland, 04400
        • Järvenpää Vaccine Research Clinic
      • Kokkola, Finland, 67100
        • Kokkola Vaccine Research Centre
      • Lahti, Finland, 15140
        • Lahti Vaccine Research Clinic
      • Oulu, Finland, 90220
        • Oulu Vaccine Research Clinic
      • Pori, Finland, 28100
        • Porin Rokotetutkimusklinikka
      • Seinäjoki, Finland, 60100
        • Seinäjoki Vaccine Research Clinic
      • Tampere, Finland, 33100
        • Tampere Vaccine Research Clinic
      • Turku, Finland, 20520
        • Turku Vaccine Research Clinic
      • Vantaa, Finland, 01300
        • Vantaa East Vaccine Research Clinic
  • Germany
      • Bad Saulgau, Germany, 88348
        • Arztpraxis
      • Bramsche, Germany, 49565
        • Kinderarzt-Praxis
      • Kleve, Germany, 47533
        • Arztpraxis
      • Mainz, Germany, 55131
        • UNIVERSITAETSMEDIZIN der Johannes Gutenberg-Universitaet Mainz
      • Neumuenster, Germany, 24534
        • Arztpraxis
      • Neumuenster, Germany, 24534
        • Kinderarztpraxis
      • Neustadt/Aisch, Germany, 91413
        • Kinderarztpraxis
  • Poland
      • Debica, Poland, 39-200
        • Gabinet Lekarski
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny, im. Jana Pawla II
      • Krakow, Poland, 31-223
        • NZOZ "HIPOKRATES-II" Sp. z o.o.
      • Leczna, Poland, 21-010
        • NZOZ Salmed
      • Lubartow, Poland, 21-100
        • Nzoz "Anamed" S.C
      • Lublin, Poland, 20-044
        • NZOZ Praktyka Lekarza Rodzinnego Eskulap
      • Oborniki Slaskie, Poland, 55-120
        • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
      • Poznan, Poland, 61709
        • Specjalistyczny ZOZ nad Matka i Dzieckiem,
      • Siemianowice Slaskie, Poland, 41-103
        • NZLA Michalkowice Jarosz i Partnerzy
      • Torun, Poland, 87-100
        • NZOZ Nasz Lekarz
      • Trzebnica, Poland, 55-100
        • Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
  • Spain
      • Almeria, Spain, 04120
        • Hospital Virgen del Mar
      • Barcelona, Spain, 08042
        • Cap Roquetes-Canteres
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46011
        • Centro de Salud Malvarrosa
      • Valencia, Spain, 46023
        • Centro de Salud Trafalgar
      • Valencia, Spain, 46020
        • Centro Superior de Investigacion en Salud Publica
      • Valencia, Spain, 46020
        • Centro Superior de Salud Publica
      • Valencia, Spain, 46021
        • Centro de Salud Republica Argentina
    • Barcelona
      • SANT Vicenç DEL Horts, Barcelona, Spain, 08620
        • Cap Vila Vella
      • Sant Cugat Del Valles, Barcelona, Spain, 08195
        • Hospital General De Catalunya
    • Girona
      • Blanes, Girona, Spain, 17300
        • Institut Pediatric Mares-Riera
    • Valencia
      • Paiporta, Valencia, Spain, 46200
        • Centro de Salud de Paiporta
      • Quart de Poblet, Valencia, Spain, 46930
        • Centro de Salud Quart de Poblet
  • Sweden
      • Eskilstuna, Sweden, 631 88
        • Malarsjukhuset, Infektionsmottagningen
      • Malmo, Sweden, 205 02
        • Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum
      • Orebro, Sweden, 703 62
        • CRS, Clinical Research Support

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 (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
  • Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Male or female subject aged ≥11 and <19 years at the time of enrollment.
  • Available for the entire study period and can be reached by telephone.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
  • Negative urine pregnancy test for female subjects.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
  • History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
  • Current chronic use of systemic antibiotics.
  • Participation in other studies during study participation. Participation in purely observational studies is acceptable.
  • Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  • Subject is pregnant or breastfeeding.
  • Subject is a direct descendant of study site or Pfizer personnel

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 Assignment
  • 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: Group 1
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Names:
  • Group 1
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Names:
  • Group 2
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Names:
  • Group 3
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Names:
  • Group 4
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Names:
  • Group 5
Experimental: Group 2
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Names:
  • Group 1
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Names:
  • Group 2
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Names:
  • Group 3
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Names:
  • Group 4
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Names:
  • Group 5
Experimental: Group 3
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Names:
  • Group 1
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Names:
  • Group 2
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Names:
  • Group 3
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Names:
  • Group 4
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Names:
  • Group 5
Experimental: Group 4
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Names:
  • Group 1
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Names:
  • Group 2
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Names:
  • Group 3
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Names:
  • Group 4
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Names:
  • Group 5
Experimental: Group 5
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Biological: Vaccine
rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Other Names:
  • Group 1
Biological: Vaccine
rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Other Names:
  • Group 2
Biological: Vaccine
rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Other Names:
  • Group 3
Biological: Vaccine
rLP2086 at visits 1 and 3, saline at visits 2 and 5
Other Names:
  • Group 4
Biological: Vaccine
rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other Names:
  • Group 5

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 Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
Time Frame: 1 month after Injection 4
1 month after Injection 4
Percentage of Participants Reporting At Least 1 Adverse Event (AE)
Time Frame: Injection 1 up to 1 month after Injection 4
Injection 1 up to 1 month after Injection 4

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 hSBA Titer >=LLOQ: Group 3 Participants
Time Frame: 1 month after Injection 4
1 month after Injection 4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Time Frame: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Percentage of Participants Achieving hSBA Titer >=LLOQ
Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4
Before Injection 1, 1 Month after Injection 2, 3, 4
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4
Before Injection 1, 1 Month after Injection 2, 3, 4

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
Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer
Time Frame: 1 month after Injection 2, 3, 4
1 month after Injection 2, 3, 4

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

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 (Actual)

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.
March 3, 2011

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.
May 3, 2012

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.
September 18, 2012

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).
February 15, 2011

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.
February 16, 2011

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.
February 18, 2011

Study Record Updates

Last Update Posted (Actual)

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.
October 27, 2022

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.
October 26, 2022

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.
October 1, 2022

More Information

Terms related to this study

Keywords

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.
  • B1971012
  • 6108A1-2003 (Other Identifier: Alias Study Number)
  • 2009-014493-18 (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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