You are here

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 May 11, 2018

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
Completed
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Clostridium Difficile Infection
NCT03090191
All Genders
50+
Years
Multiple Sites
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
NCT03329092
All Genders
18+
Years
Multiple Sites
Pneumococcal Infections
NCT03512288
All Genders
0+
Years
Multiple Sites
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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
MENINGOCOCCAL INFECTION
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
March 1, 2017
March 1, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
24 Months to 10 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland,   Poland
 
 
NCT02531698
B1971017
2014-000933-21 ( EudraCT Number )
6108K2-3012 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now