Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
NCT ID: NCT02534935
Last Updated: 2021-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
396 participants
INTERVENTIONAL
2015-08-31
2020-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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rLP2086 vaccine
Arm stratified by age:
≥12 to \<18 months and ≥18 to \<24 months
rLP2086 vaccine
60 mcg or 120mcg at 0, 2 and 6 months
Control
Arm stratified by age:
≥12 to \<18 months and ≥18 to \<24 months
Pediatric HAV vaccine
0.5-mL dose at months 0 and 6. Normal saline at month 2.
Interventions
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rLP2086 vaccine
60 mcg or 120mcg at 0, 2 and 6 months
Pediatric HAV vaccine
0.5-mL dose at months 0 and 6. Normal saline at month 2.
Eligibility Criteria
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Inclusion Criteria
* Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
* Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
* Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
* Contraindication to vaccination with any HAV vaccine or known latex allergy.
* 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 disorder of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
* Current chronic use of systemic antibiotics.
* Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
* Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
12 Months
24 Months
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Canberra Hospital
Canberra, Garran, Australian Capital Territory, Australia
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, Australia
Maroubra Medical Centre
Maroubra, New South Wales, Australia
Women's And Children's Hospital
North Adelaide, South Australia, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital
Nedlands, Western Australia, Australia
Ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
Medicentrum 6 s.r.o
Praha 6 - Vokovice, , Czechia
Prakticky Lekar Pro Deti A Mladez
Týnec nad Sázavou, , Czechia
Espoo Vaccine Research Clinic
Espoo, , Finland
Helsinki South Vaccine Research Clinic
Helsinki, , Finland
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Jarvenpaa Vaccine Research Center
Järvenpää, , Finland
Pori Vaccine Research Clinic
Pori, , Finland
Tampere Vaccine Research Clinic
Tampere, , Finland
Turku Vaccine Research Clinic
Turku, , Finland
NZOZ Vitamed
Bydgoszcz, , Poland
Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
Dębica, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka
Krakow, , Poland
Specjalistyczna Praktyka Lekarska GRAVITA
Lodz, , Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap sp. z o.o
Lublin, , Poland
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, , Poland
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Oddzial Pediatryczny
Trzebnica, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob
Wroclaw, , Poland
Countries
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References
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Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-004400-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971035
Identifier Type: -
Identifier Source: org_study_id
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