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

Phase 2

Completed

• Conditions: Meningococcal Vaccine
• Interventions: Biological: Vaccine

• Registration Number: NCT01299480
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-03-03
• Primary Completion: 2012-05-03
• Study Completion: 2012-09-18
• Results First Submitted: 2014-11-21
• Results First Submitted QC: 2015-06-02
• Results First Posted: 2015-06-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1714

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Vaccine	rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
Group 5	Vaccine	rLP2086 at visits 3 and 5, saline at visits 1 and 2
Group 3	Vaccine	rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
Group 2	Vaccine	rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
Group 4	Vaccine	rLP2086 at visits 1 and 3, saline at visits 2 and 5

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting At Least 1 Adverse Event (AE)	Injection 1 up to 1 month after Injection 4
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	1 month after Injection 4

Secondary Outcome Measures

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

Trial Locations

Locations (46)

Krakowski Szpital Specjalistyczny, im. Jana Pawla II; 🇵🇱 Krakow, Poland

Gabinet Lekarski; 🇵🇱 Debica, Poland

Nzoz "Anamed" S.C; 🇵🇱 Lubartow, Poland

NZLA Michalkowice Jarosz i Partnerzy; 🇵🇱 Siemianowice Slaskie, Poland

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny; 🇵🇱 Trzebnica, Poland

Centro de Salud de Paiporta; 🇪🇸 Paiporta, Valencia, Spain

Tampere Vaccine Research Clinic; 🇫🇮 Tampere, Finland

Ordinace praktickeho lekare pro deti a dorost; 🇨🇿 Sezemice, Czechia

Fakultni nemocnice Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

Infektionsmedicinsk Afdeling Q; 🇩🇰 Aarhus N, Denmark

Järvenpää Vaccine Research Clinic; 🇫🇮 Järvenpää, Finland

Helsinki South Vaccine Research Clinic; 🇫🇮 Helsinki, Finland

Lahti Vaccine Research Clinic; 🇫🇮 Lahti, Finland

Turku Vaccine Research Clinic; 🇫🇮 Turku, Finland

Arztpraxis; 🇩🇪 Neumuenster, Germany

Kinderarzt-Praxis; 🇩🇪 Bramsche, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; 🇩🇪 Mainz, Germany

Kinderarztpraxis; 🇩🇪 Neustadt/Aisch, Germany

NZOZ "Hipokrates-II" Sp. z o.o.; 🇵🇱 Krakow, Poland

NZOZ Praktyka Lekarza Rodzinnego Eskulap; 🇵🇱 Lublin, Poland

NZOZ Nasz Lekarz; 🇵🇱 Torun, Poland

Centro de Salud Malvarrosa; 🇪🇸 Valencia, Spain

Hospital Virgen Del Mar; 🇪🇸 Almeria, Spain

Centro de Salud Quart de Poblet; 🇪🇸 Quart de Poblet, Valencia, Spain

Cap Roquetes-Canteres; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Malarsjukhuset, Infektionsmottagningen; 🇸🇪 Eskilstuna, Sweden

Centro Superior de Investigacion en Salud Publica; 🇪🇸 Valencia, Spain

Centro Superior de Salud Publica; 🇪🇸 Valencia, Spain

Centro de Salud Republica Argentina; 🇪🇸 Valencia, Spain

Centro de Salud Trafalgar; 🇪🇸 Valencia, Spain

Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum; 🇸🇪 Malmo, Sweden

CRS, Clinical Research Support; 🇸🇪 Orebro, Sweden

Institut Pediatric Mares-Riera; 🇪🇸 Blanes, Girona, Spain

Cap Vila Vella; 🇪🇸 SANT Vicenç DEL Horts, Barcelona, Spain

NZOZ Salmed; 🇵🇱 Leczna, Poland

Seinäjoki Vaccine Research Clinic; 🇫🇮 Seinäjoki, Finland

Espoo Vaccine Research Clinic; 🇫🇮 Espoo, Finland

Helsinki East Vaccine Research Clinic; 🇫🇮 Helsinki, Finland

Kokkola Vaccine Research Centre; 🇫🇮 Kokkola, Finland

Porin Rokotetutkimusklinikka; 🇫🇮 Pori, Finland

Oulu Vaccine Research Clinic; 🇫🇮 Oulu, Finland

Vantaa East Vaccine Research Clinic; 🇫🇮 Vantaa, Finland

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak; 🇵🇱 Oborniki Slaskie, Poland

Specjalistyczny ZOZ nad Matka i Dzieckiem,; 🇵🇱 Poznan, Poland

Hospital General de Catalunya; 🇪🇸 Sant Cugat Del Valles, Barcelona, Spain