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.

NCT ID: NCT01323270

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 753 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-18
• Study Completion Date: 2013-02-19

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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Conditions

Meningococcal Vaccine; rLP2086; Repevax; N Meningitidis Serogroup B; Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

rLP2086

rLP2086 and Repevax

Group Type: EXPERIMENTAL

rLP2086

Intervention Type: BIOLOGICAL

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

Repevax

Intervention Type: BIOLOGICAL

0.5 mL dose, given at 0 months.

Saline and Repevax

Saline and Repevax

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: BIOLOGICAL

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

Repevax

Intervention Type: BIOLOGICAL

0.5 mL dose, given at 0 months.

Interventions

rLP2086

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

Intervention Type: BIOLOGICAL

Repevax

0.5 mL dose, given at 0 months.

Intervention Type: BIOLOGICAL

Saline

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

Intervention Type: BIOLOGICAL

Repevax

0.5 mL dose, given at 0 months.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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, 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Espoo Vaccine Research Clinic

Espoo, , Finland

Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Ita-Helsinki Vaccine Research Clinic

Helsinki, , Finland

Järvenpää Vaccine Research Clinic

Järvenpää, , Finland

Kokkola Vaccine Research Clinic

Kokkola, , Finland

Lahti Vaccine Research Clinic

Lahti, , Finland

Oulu Vaccine Research Clinic

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Seinäjoki Vaccine Research Clinic

Seinäjoki, , Finland

Tampereen Yliopisto University Of Tampere

Tampere, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Vaccine Research Center

Tampere, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Vantaa Vaccine Research Clinic

Vantaa, , Finland

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

Bad Sobernheim, , Germany

Gerhard Bleckmann Kinder- und Jugendarzt

Baunatal, , Germany

Kinderarzt-Praxis

Bramsche, , Germany

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

Kehl, , Germany

Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin

Lübeck, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , Germany

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

Schwäbisch Hall, , Germany

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

Vellmar, , Germany

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

Weilheim, , Germany

Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim

Welzheim, , Germany

Gabinet Lekarski

Dębica, , Poland

Krakowski Szpital Specjalistyczny, im. Jana Pawla II

Krakow, , Poland

Specjalistyczna Praktyka Lekarska Gravita

Lodz, , Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny

Lubartów, , Poland

NZOZ Praktyka Lekarza Rodzinnego Eskulap

Lublin, , Poland

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak

Oborniki Śląskie, , Poland

Specjalistyczny ZOZ nad Matka i Dzieckiem, Przychodnia Wieku Rozwojowego

Poznan, , Poland

NZLA Michalkowice Jarosz i Partnerzy

Siemianowice Śląskie, , Poland

NZOZ Nasz Lekarz

Torun, , Poland

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

Trzebnica, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, , Poland

NZOZ Salmed

Łęczna, , Poland

Countries

Finland; Germany; Poland

References

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.

Reference Type: DERIVED

PMID: 35164991 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32681472 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26803328 (View on PubMed)

Other Identifiers

6108A1-2008

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022449-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1971010

Identifier Type: -

Identifier Source: org_study_id