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

NCT ID: NCT02531698

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-31

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.

Conditions

MENINGOCOCCAL INFECTION

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bivalent rLP2086

Bivalent rLP2086 (containing 60 μg each of a purified subfamily A and subfamily B rLP2086 protein, adsorbed to aluminum in a sterile buffered isotonic suspension) in a 0.5-mL dose for injection.

Group Type: EXPERIMENTAL

Bivalent rLP2086 Vaccine

Intervention Type: BIOLOGICAL

1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.

Licensed pediatric hepatitis A vaccine

Group Type: OTHER

Licensed pediatric hepatits A vaccine

Intervention Type: BIOLOGICAL

1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.

Normal Saline

Intervention Type: OTHER

Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Interventions

Bivalent rLP2086 Vaccine

1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.

Intervention Type: BIOLOGICAL

Licensed pediatric hepatits A vaccine

1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.

Intervention Type: BIOLOGICAL

Normal Saline

Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Espoo Vaccine Research Clinic

Espoo, , Finland

Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Oulu Vaccine Research Clinic

Oulu, , Finland

Pori Vaccine Research Clinic

Pori, , Finland

Tampere Vaccine Research Clinic

Tampere, , Finland

Turku Vaccine Research Center

Turku, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek

Dębica, , Poland

Praktyka Lekarza Rodzinnego-Slawin Sp. z o.o.

Kiełczów, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, , Poland

Hanna Czajka - Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, , Poland

Specjalistyczna Przychodnia Medycyny Wieku Rozwojowego

Poznan, , Poland

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego "Michalkowice"Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 We Wroclawiu

Wroclaw, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.

Łęczna, , Poland

Countries

Finland; Poland

References

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.

Reference Type: DERIVED

PMID: 36087588 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971017&StudyName=A%20Phase%202%2C%20Randomized%2C%20Controlled%2C%20Observer-blinded%20Study%20To%20Describe%20The%20Immunogenicity%2C%20Safety%2C%20And%20Tolerability%20Of%20Neisseria%20Meningitidis%20Serogroup%20B%20Bivalent%20Recombinant%20Lipoprotein%202086%20Vaccine%20%28bivalent%20Rlp2086%29%20In%20Healthy%20Subjects%20Aged%20greater%20than%2F%3D%2024%20Months%20To%20less%20than10%20Years

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Other Identifiers

2014-000933-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6108K2-3012

Identifier Type: OTHER

Identifier Source: secondary_id

B1971017

Identifier Type: -

Identifier Source: org_study_id