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Meningococcal VaccinePhase 2NCT01323270

A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

A Phase 2 study testing rLP2086, Repevax and Saline in people with Meningococcal Vaccine and rLP2086, run by Pfizer at 36 sites in 3 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 it is tolerated when given together with Repevax. The 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, rLP2086, Repevax
What is being tested?
rLP2086, Repevax and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
753 participants
Where
36 sitesin 3 countries
Study dates
18 Mar 2011to 19 Feb 2013
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, 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.
  • Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
  • 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.
  • Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
  • 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.
Show all 17Show fewer
  • 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 a direct descendant (eg, child, grandchild or other family member) of study site or Pfizer personnel.
  • Subject is pregnant or breastfeeding.

Trial locations and contacts

36 sites in 3 countries.

36 sites in 3 countries

Finland14 sites

  • Espoo Vaccine Research Clinic

    Espoo, 02100

  • Helsinki South Vaccine Research Clinic

    Helsinki, 00100

  • Ita-Helsinki Vaccine Research Clinic

    Helsinki, 00930

  • Järvenpää Vaccine Research Clinic

    Jarvenpaa, 04400

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • Lahti Vaccine Research Clinic

    Lahti, 15140

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinäjoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampereen Yliopisto University Of Tampere

    Tampere, 33014

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Vaccine Research Center

    Tampere, FIN-33014

  • Turku Vaccine Research Clinic

    Turku, 20520

  • Vantaa Vaccine Research Clinic

    Vantaa, 01300

Other trials in Finland

Poland12 sites

  • Gabinet Lekarski

    Dębica, 39-200

  • Krakowski Szpital Specjalistyczny, im. Jana Pawla II

    Krakow, 31-202

  • NZOZ Salmed

    Łęczna, 21-010

  • Specjalistyczna Praktyka Lekarska Gravita

    Lodz, 91-347

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny

    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, Przychodnia Wieku Rozwojowego

    Poznan, 61-825

  • 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

  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

    Wroclaw, 50-345

Other trials in Poland

Germany10 sites

  • Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf

    Bad Sobernheim, 55566

  • Gerhard Bleckmann Kinder- und Jugendarzt

    Baunatal, 34225

  • Kinderarzt-Praxis

    Bramsche, 49565

  • Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel

    Kehl, 77694

  • Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin

    Lübeck, 23566

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131

  • Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte

    Schwäbisch Hall, 74523

  • Thomas Lenz & (Frau) Dr. med. Marin Eggers

    Vellmar, 34246

  • Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche

    Weilheim, 82362

  • Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim

    Welzheim, 73642

Other trials in Germany

About this study

Official title: A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly 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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Being tested
rLP2086, Repevax, Saline
Keywords
Healthy adolescents
Medical subject headings
Meningitis

What participants receive

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

  • rLP2086Biological

    0.5 mL dose, given at 0, 2 and 6 months.

  • RepevaxBiological

    0.5 mL dose, given at 0 months.

  • SalineBiological

    0.5 mL dose, given at 0, 2 and 6 months.

  • RepevaxBiological

    0.5 mL dose, given at 0 months.

Study groups in NCT01323270
Study groupRoleWhat they receive
rLP2086ExperimentalrLP2086 and Repevax
Receives: Biological: rLP2086; Biological: Repevax
Saline and RepevaxPlacebo comparatorSaline and Repevax
Receives: Biological: Saline; Biological: Repevax

What is being measured

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

  1. Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen

    Measured: 1 month after Vaccination 1

  2. Percentage of Participants With at Least One Adverse Event (AE)

    Measured: Vaccination 1 up to 1 month after Vaccination 3

Secondary outcomes (4)

  1. Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens

    Measured: 1 month after Vaccination 1

  2. GMC for Acellular Pertussis Antigens

    Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)

    Measured: 1 month after Vaccination 1

  3. Geometric Mean Titer (GMT) for Poliomyelitis Antigens

    Measured: 1 month after Vaccination 1

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

    Measured: 1 month after Vaccination 3

Timeline

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

  1. First posted25 Mar 2011 (estimated)
  2. Study start18 Mar 2011
  3. Primary completion8 Oct 2012
  4. Study completion19 Feb 2013

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
753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323270
Sponsor's protocol ID
B1971010
Other IDs
6108A1-2008, 2010-022449-38
Status last verified
Oct 2022
First submitted
17 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, Wysocki J, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Perez JL. Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):180-7. doi: 10.1093/jpids/piv064. Epub 2016 Jan 23.

    PubMed 26803328

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rLP2086, Repevax and Saline in people with Meningococcal Vaccine and rLP2086, run by Pfizer at 36 sites in 3 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 8 inclusion and 17 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 36 sites in Finland, Poland, Germany. 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. Some participants in this study may receive a placebo. 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 26 Nov 2014). 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 Prespecified Criteria for the Concomitant Antigen (time frame: 1 month after Vaccination 1). 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 NCT01323270, 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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