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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

Last updated on March 23, 2020

FOR MORE INFORMATION
Study Location
Espoo Vaccine Research Clinic
Espoo, , 02230 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
MENINGOCOCCAL INFECTION
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
24 + months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 stratified equally by age (≥24 months to

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT02531698
Pfizer
Active, not recruiting
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

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Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE MENINGOCOCCAL INFECTION
Intervention  ICMJE
  • Biological: Bivalent rLP2086 Vaccine
    1 dose of 120 ?g of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.
  • 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.
  • Other: Normal Saline
    Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.
Study Arms  ICMJE
  • Experimental: Bivalent rLP2086
    Bivalent rLP2086 (containing 60 ?g 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.
    Intervention: Biological: Bivalent rLP2086 Vaccine
  • Licensed pediatric hepatitis A vaccine
    Interventions:
    • Biological: Licensed pediatric hepatits A vaccine
    • Other: Normal Saline
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2015)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531698
Other Study ID Numbers  ICMJE B1971017
2014-000933-21 ( EudraCT Number )
6108K2-3012 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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