Overview

This trial is active, not recruiting.

Condition meningococcal infection
Treatments bivalent rlp2086 vaccine, licensed pediatric hepatits a vaccine, normal saline
Phase phase 2
Sponsor Pfizer
Start date August 2015
End date February 2017
Trial size 400 participants
Trial identifier NCT02531698, 2014-000933-21, 6108K2-3012, B1971017

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
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.
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.
(Other)
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.
normal saline
Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Primary Outcomes

Measure
Proportion of subjects with antibody titers ≥lower limit of quantitation for each of the 4 primary Neisseria meningitidis serogroup B test strains 1 month after the third vaccination with bivalent rLP2086
time frame: Month 7
Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit
time frame: Month 0
Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit
time frame: Month 2
Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit
time frame: Month 6
Percentage of subjects with at least 1 SAE 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period
time frame: Up to 12 months
Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period
time frame: Up to 12 months
Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period
time frame: Up to 12 months
Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccination and during the vaccination phase
time frame: Up to 7 months
Percentage of subjects reporting at least 1 immediate AE after each vaccination
time frame: Month 0
Percentage of subjects reporting at least 1 immediate AE after each vaccination
time frame: Month 2
Percentage of subjects reporting at least 1 immediate AE after each vaccination
time frame: Month 6
Subject's days missing school due to AEs during the vaccination phase
time frame: Up to 7 months

Secondary Outcomes

Measure
Proportion of subjects with antibody titers ≥lower limit of quantitation for each of the 4 primary Neisseria meningitidis serogroup B test strains 1 month after the second vaccination and 1 and 6 months after the third vaccination with bivalent rLP2086
time frame: Up to 12 months
Proportion of subjects achieving fold rises in antibody titers for each of the 4 primary test strains at baseline, 1 month after the second vaccination, and 1 and 6 months after the third vaccination with bivalent rLP2086
time frame: Up to 12 months
Geometric mean antibody titers for each of the 4 primary test strains at baseline, 1 month after the second vaccination, and 1 and 6 months after the third vaccination with bivalent rLP2086
time frame: Up to 12 months

Eligibility Criteria

Male or female participants from 24 months up to 10 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.