Clinical trial NCT01323270: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Vaccine
rLP2086
Repevax
N Meningitidis Serogroup B
Meningitis
Keywords: Healthy adolescents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 753
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen
timeFrame: 1 month after Vaccination 1
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Vaccination 1 up to 1 month after Vaccination 3
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens
timeFrame: 1 month after Vaccination 1
measure: GMC for Acellular Pertussis Antigens
timeFrame: 1 month after Vaccination 1
measure: Geometric Mean Titer (GMT) for Poliomyelitis Antigens
timeFrame: 1 month after Vaccination 1
measure: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level
timeFrame: 1 month after Vaccination 3
Other outcomes:
measure: Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)
timeFrame: Before vaccination 1, 1 month after Vaccination 2, 3
measure: Geometric Mean Fold-Rise (GMFR) for IgG
timeFrame: Before Vaccination 1, 1 month after Vaccination 2, 3
Locations:
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Ita-Helsinki Vaccine Research Clinic
city: Järvenpää
country: Finland
facility: Järvenpää Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Lahti
country: Finland
facility: Lahti Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampereen Yliopisto University Of Tampere
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Tampere
country: Finland
facility: Vaccine Research Center
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Vantaa
country: Finland
facility: Vantaa Vaccine Research Clinic
city: Bad Sobernheim
country: Germany
facility: Gemeinschaftspraxis Dr. med. Guido Hein, Dr. med. Rainer Lauf
city: Baunatal
country: Germany
facility: Gerhard Bleckmann Kinder- und Jugendarzt
city: Bramsche
country: Germany
facility: Kinderarzt-Praxis
city: Kehl
country: Germany
facility: Gemeinschaftspraxis fuer Kinder- und Jugendmedizin Dres. Behre, Burgert, Gunkel
city: Luebeck
country: Germany
facility: Dr. med. Sobhi Mahdi Kinderarzt und Jugendmedizin
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Schwaebisch-Hall
country: Germany
facility: Dr. Michael Vomstein, Hermann Oesterle, Kinder- und Jugendaerzte
city: Vellmar
country: Germany
facility: Thomas Lenz & (Frau) Dr. med. Marin Eggers
city: Weilheim
country: Germany
facility: Dres.T. Schmitz, H. Knee, Ch, Wittermann Fachaerztliche
city: Welzheim
country: Germany
facility: Gemeinschaftspraxis fuer Kinder und Jugendliche Welzheim
city: Debica
country: Poland
facility: Gabinet Lekarski
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny, im. Jana Pawla II
city: Leczna
country: Poland
facility: NZOZ Salmed
city: Lodz
country: Poland
facility: Specjalistyczna Praktyka Lekarska Gravita
city: Lubartow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Pediatryczny
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap
city: Oborniki Slaskie
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
city: Poznan
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Przychodnia Wieku Rozwojowego
city: Siemianowice Slaskie
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.