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Meningococcal VaccinePhase 2NCT01299480

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

A Phase 2 study testing Vaccine in people with Meningococcal Vaccine, run by Pfizer at 63 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Vaccine
What is being tested?
Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,714 participants
Where
63 sitesin 7 countries
Study dates
3 Mar 2011to 18 Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 15Show fewer
  • 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

Trial locations and contacts

63 sites in 7 countries.

63 sites in 7 countries

Czechia16 sites

  • Ordinace praktickeho lekare pro deti a dorost

    Brandýs nad Labem-Stará Boleslav, 25001

  • Ordinace praktickeho lekare pro deti a dorost

    Chlumec nad Cidlinou, 50351

  • Ordinace praktickeho lekare pro deti a dorost

    Holice, 53401

  • Ordinace praktickeho lekare pro deti a dorost

    Hradec Králové, 50002

  • Ordinace praktickeho lekare pro deti a dorost

    Hradec Králové, 50004

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 37701

  • Ordinace praktickeho lekare pro deti a dorost

    Odolena Voda, 25070

  • Ordinace praktickeho lekare pro deti a dorost

    Pardubice, 53002

  • Ordinace praktickeho lekare pro deti a dorost

    Pardubice, 53012

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 11000

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 16000

  • Ordinace praktickeho lekare pro deti a dorost

    Praha - Horni Pocernice, 19300

  • Ordinace praktickeho lekare pro deti a dorost

    Praha - Nusle, 14000

  • Ordinace praktickeho lekare pro deti a dorost

    Praha 6 - Petriny, 16200

  • Ordinace praktickeho lekare pro deti a dorost

    Sezemice, 53304

Other trials in Czechia

Spain13 sites

  • Hospital Virgen Del Mar

    Almería, 04120

  • Cap Roquetes-Canteres

    Barcelona, 08042

  • Institut Pediatric Mares-Riera

    Blanes, Girona, 17300

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro de Salud de Paiporta

    Paiporta, Valencia, 46200

  • Centro de Salud Quart de Poblet

    Quart de Poblet, Valencia, 46930

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

  • Cap Vila Vella

    SANT Vicenç DEL Horts, Barcelona, 08620

  • Centro de Salud Malvarrosa

    Valencia, 46011

  • Centro Superior de Investigacion en Salud Publica

    Valencia, 46020

  • Centro Superior de Salud Publica

    Valencia, 46020

  • Centro de Salud Republica Argentina

    Valencia, 46021

  • Centro de Salud Trafalgar

    Valencia, 46023

Other trials in Spain

Finland12 sites

  • Espoo Vaccine Research Clinic

    Espoo, 02230

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Helsinki East Vaccine Research Clinic

    Helsinki, 00930

  • Järvenpää Vaccine Research Clinic

    Jarvenpaa, 04400

  • Kokkola Vaccine Research Centre

    Kokkola, 67100

  • Lahti Vaccine Research Clinic

    Lahti, 15140

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Porin Rokotetutkimusklinikka

    Pori, 28100

  • Seinäjoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

  • Vantaa East Vaccine Research Clinic

    Vantaa, 01300

Other trials in Finland

Poland11 sites

  • Gabinet Lekarski

    Dębica, 39-200

  • Krakowski Szpital Specjalistyczny, im. Jana Pawla II

    Krakow, 31-202

  • NZOZ "Hipokrates-II" Sp. z o.o.

    Krakow, 31-223

  • NZOZ Salmed

    Łęczna, 21-010

  • Nzoz "Anamed" S.C

    Lubartów, 21-100

  • NZOZ Praktyka Lekarza Rodzinnego Eskulap

    Lublin, 20-044

  • NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

    Oborniki Śląskie, 55-120

  • Specjalistyczny ZOZ nad Matka i Dzieckiem,

    Poznan, 61709

  • NZLA Michalkowice Jarosz i Partnerzy

    Siemianowice Śląskie, 41-103

  • NZOZ Nasz Lekarz

    Torun, 87-100

  • Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

    Trzebnica, 55-100

Other trials in Poland

Germany7 sites

  • Arztpraxis

    Bad Saulgau, 88348

  • Kinderarzt-Praxis

    Bramsche, 49565

  • Arztpraxis

    Kleve, 47533

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Arztpraxis

    Neumünster, 24534

  • Kinderarztpraxis

    Neumünster, 24534

  • Kinderarztpraxis

    Neustadt/Aisch, 91413

Other trials in Germany

Sweden3 sites

  • Malarsjukhuset, Infektionsmottagningen

    Eskilstuna, 631 88

  • Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum

    Malmö, 205 02

  • CRS, Clinical Research Support

    Örebro, 703 62

Other trials in Sweden

Denmark1 site

  • Infektionsmedicinsk Afdeling Q

    Aarhus N, 8200

Other trials in Denmark

About this study

Official title: 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.

Being tested
Vaccine
Keywords
Healthy adolescents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VaccineBiological

    Also called Group 1

    rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3

  • VaccineBiological

    Also called Group 2

    rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2

  • VaccineBiological

    Also called Group 3

    rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3

  • VaccineBiological

    Also called Group 4

    rLP2086 at visits 1 and 3, saline at visits 2 and 5

  • VaccineBiological

    Also called Group 5

    rLP2086 at visits 3 and 5, saline at visits 1 and 2

Study groups in NCT01299480
Study groupRoleWhat they receive
Group 1ExperimentalrLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Receives: Biological: Vaccine
Group 2ExperimentalrLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Receives: Biological: Vaccine
Group 3ExperimentalrLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Receives: Biological: Vaccine
Group 4ExperimentalrLP2086 at visits 1 and 3, saline at visits 2 and 5
Receives: Biological: Vaccine
Group 5ExperimentalrLP2086 at visits 3 and 5, saline at visits 1 and 2
Receives: Biological: Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month after Injection 4

  2. Percentage of Participants Reporting At Least 1 Adverse Event (AE)

    Measured: Injection 1 up to 1 month after Injection 4

Secondary outcomes (4)

  1. Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants

    Measured: 1 month after Injection 4

  2. Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)

    Measured: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4

  3. Percentage of Participants Achieving hSBA Titer >=LLOQ

    Measured: Before Injection 1, 1 Month after Injection 2, 3, 4

  4. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

    Measured: Before Injection 1, 1 Month after Injection 2, 3, 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2011 (estimated)
  2. Study start3 Mar 2011
  3. Primary completion3 May 2012
  4. Study completion18 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01299480
Sponsor's protocol ID
B1971012
Other IDs
6108A1-2003, 2009-014493-18, 2009
Status last verified
Oct 2022
First submitted
15 Feb 2011
Last updated
27 Oct 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35164991

  • 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.

    PubMed 32681472

  • Vesikari T, Ostergaard L, Diez-Domingo J, Wysocki J, Flodmark CE, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Crowther G, Perez JL. Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):152-60. doi: 10.1093/jpids/piv039. Epub 2015 Aug 4.

    PubMed 26407272

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaccine in people with Meningococcal Vaccine, run by Pfizer at 63 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Czechia, Spain, Finland, Poland, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01299480, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.

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