Clinical trial NCT02531698: A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
Official title: A Phase 2, Randomized, Controlled, Observer-blinded Study To Describe The Immunogenicity, Safety, And Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent Rlp2086) In Healthy Subjects Aged >/= 24 Months To <10 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MENINGOCOCCAL INFECTION
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 400
Sex: ALL
Minimum age (years): 24
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated.


Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
2. Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
3. Male or female subjects aged ≥24 months and \<10 years at time of randomization, stratified equally by age (≥24 months to \<4 years or ≥4 years to \<10 years).
4. Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
6. Subject must have received all vaccinations in the relevant national immunization program (NIP) for their age group.
7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
8. Negative urine pregnancy test for all female subjects who are biologically capable of having children.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Contraindication to vaccination with any HAV vaccine or known latex allergy.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or subjects receiving allergen immunotherapy with a licensed product and who are not on stable maintenance doses.
5. A previous anaphylactic reaction to any vaccine or vaccine-related component.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. A known or suspected defect 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, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Additional details will be provided in the study reference manual (SRM).
8. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
9. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
10. Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
11. Current chronic use of systemic antibiotics.
12. Participation in other studies involving investigational product(s)/device(s) (Phases 1-4) within 28 days before administration of the first study vaccination. Participation in purely observational studies is acceptable.
13. Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
14. 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.
15. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
16. Subjects who are children of investigational site staff members directly involved in the conduct of the study and their family members, subjects who are children of site staff members otherwise supervised by the investigator, or subjects who are children of Pfizer employees directly involved in the conduct of the study.

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 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1
timeFrame: Within 30 Days after Vaccination 1
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2
timeFrame: Within 30 Days after Vaccination 2
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3
timeFrame: Within 30 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) 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) 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) Throughout the Study
timeFrame: From Vaccination 1 up to 6 months after Vaccination 3
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1
timeFrame: Within 30 Days after Vaccination 1
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2
timeFrame: Within 30 Days after Vaccination 2
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3
timeFrame: Within 30 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase
timeFrame: From the Vaccination 1 up to 1 month after the Vaccination 3
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase
timeFrame: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
measure: Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study
timeFrame: From the Vaccination 1 up to 6 months after the Vaccination 3
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1
timeFrame: Within 30 Days after Vaccination 1
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2
timeFrame: Within 30 Days after Vaccination 2
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3
timeFrame: Within 30 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
timeFrame: From the Vaccination 1 up to 1 month after the Vaccination 3
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase
timeFrame: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
measure: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study
timeFrame: From the Vaccination 1 up to 6 months after the Vaccination 3
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1
timeFrame: Within 30 Days after Vaccination 1
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2
timeFrame: Within 30 Days after Vaccination 2
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3
timeFrame: Within 30 Days after Vaccination 3
measure: Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
timeFrame: From the Vaccination 1 up to 1 month after the Vaccination 3
measure: Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1
timeFrame: Within 30 minutes after Vaccination 1
measure: Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2
timeFrame: Within 30 minutes after Vaccination 2
measure: Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3
timeFrame: Within 30 minutes after Vaccination 3
measure: Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase
timeFrame: From the Vaccination 1 up to 1 month after the Vaccination 3
Secondary outcomes:
measure: Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3
timeFrame: 1 month 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 and 6 Months After Vaccination 3
timeFrame: 1 month after Vaccination 2 and 6 months after Vaccination 3
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, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3
measure: Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
timeFrame: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
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 Center
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Debica
country: Poland
facility: Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
city: Kielczow
country: Poland
facility: Praktyka Lekarza Rodzinnego-Slawin Sp. z o.o.
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Krakow
country: Poland
facility: Hanna Czajka - Indywidualna Specjalistyczna Praktyka Lekarska
city: Leczna
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
city: Poznan
country: Poland
facility: Specjalistyczna Przychodnia Medycyny Wieku Rozwojowego
city: Siemianowice Slaskie
country: Poland
facility: Niepubliczny Zaklad Lecznictwa Ambulatoryjnego "Michalkowice"Jarosz i Partnerzy Spolka Lekarska
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: 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.