Clinical trial NCT02534935: Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Official title: A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal B Disease
Keywords: Phase 2 Immunogenicity
Safety
Tolerability Study
rLP2086 Vaccine
Healthy Toddlers
Neisseria meningitidis
Duration of Immunogenicity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 396
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.


Eligibility criteria: Inclusion Criteria:

* Male or female subject aged 12 to \<15 months or 18 to \<24 months during sentinel-cohort enrollment, Or,12 to \<24 months during expanded-cohort enrollment.
* 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 any meningococcal serogroup B vaccine.
* 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.

Primary outcomes:
measure: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
timeFrame: within 7 Days after Vaccination 1
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
timeFrame: within 7 Days after Vaccination 2
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
timeFrame: within 7 Days after Vaccination 3
measure: Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
timeFrame: within 7 Days after Vaccination 1
measure: Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
timeFrame: within 7 Days after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
timeFrame: within 7 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1
timeFrame: within 30 Days after Vaccination 1
measure: Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2
timeFrame: within 30 Days after Vaccination 2
measure: Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3
timeFrame: within 30 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination
timeFrame: within 30 Days after any Vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
timeFrame: From the Vaccination 1 up to 1 month after Vaccination 3
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase
timeFrame: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3
timeFrame: From Vaccination 1 up to 6 months after Vaccination 3
Secondary outcomes:
measure: Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3
timeFrame: 1, 6, 12, 24 months after Vaccination 3
measure: Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2
timeFrame: 1 month (Mon) after Vaccination (Vac) 2
measure: Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains
timeFrame: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
measure: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
timeFrame: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination
timeFrame: Within 7 days after booster vaccination
measure: Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination
timeFrame: Within 7 days after booster vaccination
measure: Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination
timeFrame: Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)
measure: Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination
timeFrame: Booster vaccination up to 1 month after booster vaccination
measure: Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination
timeFrame: Within 30 minutes after booster vaccination
measure: Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination
timeFrame: Before booster vaccination and 1 month after booster vaccination
measure: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination
timeFrame: Before booster vaccination and 1 month after booster vaccination
Other outcomes:
Locations:
city: Canberra, Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Maroubra
country: Australia
facility: Australian Clinical Research Network (ACRN)
state: New South Wales
city: Maroubra
country: Australia
facility: Maroubra Medical Centre
state: New South Wales
city: North Adelaide
country: Australia
facility: Women's And Children's Hospital
state: South Australia
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
city: Nedlands
country: Australia
facility: Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital
state: Western Australia
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec
country: Czechia
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
city: Praha 6 - Vokovice
country: Czechia
facility: Medicentrum 6 s.r.o
city: Tynec Nad Sazavou
country: Czechia
facility: Prakticky Lekar Pro Deti A Mladez
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: Jarvenpaa
country: Finland
facility: Jarvenpaa Vaccine Research Center
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Debica
country: Poland
facility: Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
city: Krakow
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka
city: Lodz
country: Poland
facility: Specjalistyczna Praktyka Lekarska GRAVITA
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap sp. z o.o
city: Siemianowice Slaskie
country: Poland
facility: Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Oddzial Pediatryczny
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.