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.

Phase 2

Completed

• Conditions: Repevax; rLP2086; Meningitis; Meningococcal Vaccine; N Meningitidis Serogroup B
• Interventions: Biological: rLP2086; Biological: Saline; Biological: Repevax

• Registration Number: NCT01323270
• 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 it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-17
• Study Start: 2011-03-18
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2012-10-08
• Study Completion: 2013-02-19
• Results First Submitted: 2014-11-21
• Results First Submitted QC: 2014-11-21
• Results First Posted: 2014-11-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 753

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rLP2086	rLP2086	rLP2086 and Repevax
rLP2086	Repevax	rLP2086 and Repevax
Saline and Repevax	Saline	Saline and Repevax
Saline and Repevax	Repevax	Saline and Repevax

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen	1 month after Vaccination 1
Percentage of Participants With at Least One Adverse Event (AE)	Vaccination 1 up to 1 month after Vaccination 3

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) for Poliomyelitis Antigens	1 month after Vaccination 1
Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens	1 month after Vaccination 1
GMC for Acellular Pertussis Antigens	1 month after Vaccination 1	Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level	1 month after Vaccination 3

Trial Locations

Locations (36)

Järvenpää Vaccine Research Clinic; 🇫🇮 Järvenpää, Finland

Tampere Vaccine Research Clinic; 🇫🇮 Tampere, Finland

Gabinet Lekarski; 🇵🇱 Debica, Poland

NZOZ Nasz Lekarz; 🇵🇱 Torun, Poland

Kokkola Vaccine Research Clinic; 🇫🇮 Kokkola, Finland

Vaccine Research Center; 🇫🇮 Tampere, Finland

Vantaa Vaccine Research Clinic; 🇫🇮 Vantaa, Finland

Espoo Vaccine Research Clinic; 🇫🇮 Espoo, Finland

Ita-Helsinki Vaccine Research Clinic; 🇫🇮 Helsinki, Finland

NZOZ Praktyka Lekarza Rodzinnego Eskulap; 🇵🇱 Lublin, Poland

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

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu; 🇵🇱 Wroclaw, Poland

Lahti Vaccine Research Clinic; 🇫🇮 Lahti, Finland

Oulu Vaccine Research Clinic; 🇫🇮 Oulu, Finland

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

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

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

Pori Vaccine Research Clinic; 🇫🇮 Pori, Finland

Gerhard Bleckmann Kinder- und Jugendarzt; 🇩🇪 Baunatal, Germany

Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin; 🇩🇪 Luebeck, Germany

Helsinki South Vaccine Research Clinic; 🇫🇮 Helsinki, Finland

Tampereen Yliopisto University Of Tampere; 🇫🇮 Tampere, Finland

Seinäjoki Vaccine Research Clinic; 🇫🇮 Seinäjoki, Finland

Turku Vaccine Research Clinic; 🇫🇮 Turku, Finland

Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf; 🇩🇪 Bad Sobernheim, Germany

Kinderarzt-Praxis; 🇩🇪 Bramsche, Germany

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

Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel; 🇩🇪 Kehl, Germany

Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte; 🇩🇪 Schwaebisch-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

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

NZOZ Salmed; 🇵🇱 Leczna, Poland

Specjalistyczna Praktyka Lekarska Gravita; 🇵🇱 Lodz, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny; 🇵🇱 Lubartow, Poland