Clinical trial NCT01299480: 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
Official title: A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Vaccine
Keywords: Healthy adolescents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 1714
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 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.


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, 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

Primary outcomes:
measure: 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
timeFrame: 1 month after Injection 4
measure: Percentage of Participants Reporting At Least 1 Adverse Event (AE)
timeFrame: Injection 1 up to 1 month after Injection 4
Secondary outcomes:
measure: Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
timeFrame: 1 month after Injection 4
measure: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
timeFrame: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
measure: Percentage of Participants Achieving hSBA Titer >=LLOQ
timeFrame: Before Injection 1, 1 Month after Injection 2, 3, 4
measure: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
timeFrame: Before Injection 1, 1 Month after Injection 2, 3, 4
Other outcomes:
measure: Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer
timeFrame: 1 month after Injection 2, 3, 4
Locations:
city: Brandys nad Labem - Stara Boleslav
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Chlumec nad Cidlinou
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Holice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradec Kralove
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradec Kralove
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Odolena Voda
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha - Horni Pocernice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha - Nusle
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 1
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 6 - Petriny
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 6
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Sezemice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Aarhus N
country: Denmark
facility: Infektionsmedicinsk Afdeling Q
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Järvenpää
country: Finland
facility: Järvenpää Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Centre
city: Lahti
country: Finland
facility: Lahti Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Porin Rokotetutkimusklinikka
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Vantaa
country: Finland
facility: Vantaa East Vaccine Research Clinic
city: Bad Saulgau
country: Germany
facility: Arztpraxis
city: Bramsche
country: Germany
facility: Kinderarzt-Praxis
city: Kleve
country: Germany
facility: Arztpraxis
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Neumuenster
country: Germany
facility: Arztpraxis
city: Neumuenster
country: Germany
facility: Kinderarztpraxis
city: Neustadt/Aisch
country: Germany
facility: Kinderarztpraxis
city: Debica
country: Poland
facility: Gabinet Lekarski
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny, im. Jana Pawla II
city: Krakow
country: Poland
facility: NZOZ "Hipokrates-II" Sp. z o.o.
city: Leczna
country: Poland
facility: NZOZ Salmed
city: Lubartow
country: Poland
facility: Nzoz "Anamed" S.C
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,
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: Sant Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: SANT Vicenç DEL Horts
country: Spain
facility: Cap Vila Vella
state: Barcelona
city: Blanes
country: Spain
facility: Institut Pediatric Mares-Riera
state: Girona
city: Paiporta
country: Spain
facility: Centro de Salud de Paiporta
state: Valencia
city: Quart de Poblet
country: Spain
facility: Centro de Salud Quart de Poblet
state: Valencia
city: Almeria
country: Spain
facility: Hospital Virgen Del Mar
city: Barcelona
country: Spain
facility: Cap Roquetes-Canteres
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Centro de Salud Malvarrosa
city: Valencia
country: Spain
facility: Centro Superior de Investigacion en Salud Publica
city: Valencia
country: Spain
facility: Centro Superior de Salud Publica
city: Valencia
country: Spain
facility: Centro de Salud Republica Argentina
city: Valencia
country: Spain
facility: Centro de Salud Trafalgar
city: Eskilstuna
country: Sweden
facility: Malarsjukhuset, Infektionsmottagningen
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus Malmo, Barn- och Ungdomscentrum
city: Orebro
country: Sweden
facility: CRS, Clinical Research Support
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, Ostergaard L, Diez-Domingo J, Wysocki J, Flodmark CE, Beeslaar J, Eiden J, Jiang Q, Jansen KU, Jones TR, Harris SL, O'Neill RE, York LJ, Crowther G, Perez JL. Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents. J Pediatric Infect Dis Soc. 2016 Jun;5(2):152-60. doi: 10.1093/jpids/piv039. Epub 2015 Aug 4.