You are here

Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
The Canberra Hospital
Canberra, Garran, Australian Capital T, 2605 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal B Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-24 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subject aged 12 to sentinel-cohort enrollment, Or,12 to

- Subjects must have received all vaccinations in the relevant National Immunization
Program (NIP) for their age group.

- Subject is determined to be in good health by medical history, physical examination,
and judgment of the investigator.

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

- Previous vaccination with any meningococcal serogroup B vaccine.

- Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine
during Stage 1 of the study.

- Contraindication to vaccination with any HAV vaccine or known latex allergy.

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

- A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with
terminal complement deficiency may be included.

- History of microbiologically proven disease caused by N meningitidis or Neisseria
gonorrhoeae.

- Significant neurologic disorder or history of seizure (excluding simple febrile
seizure).

- Receipt of any blood products, including immunoglobulin, within 6 months before the
first study vaccination until the end of Stage 1.

- Current chronic use of systemic antibiotics.

- Received any investigational drugs, vaccines or devices within 28 days before
administration of the first study vaccination and/or during study participation.

- Any neuroinflammatory or autoimmune condition, including but not limited to transverse
myelitis, uveitis, optic neuritis, and multiple sclerosis.

NCT02534935
Pfizer
Active, not recruiting
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

NEED INFO?

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

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 city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Official Title  ICMJE A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086
Brief SummaryThe purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.
Detailed DescriptionNot 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 B Disease
Intervention  ICMJE
  • Biological: rLP2086 vaccine
    60 mcg or 120mcg at 0, 2 and 6 months
  • Biological: Pediatric HAV vaccine
    0.5-mL dose at months 0 and 6. Normal saline at month 2.
Study Arms  ICMJE
  • Experimental: rLP2086 vaccine

    Arm stratified by age:

    ?12 to <18 months and ?18 to <24 months

    Intervention: Biological: rLP2086 vaccine
  • Active Comparator: Control

    Arm stratified by age:

    ?12 to <18 months and ?18 to <24 months

    Intervention: Biological: Pediatric HAV vaccine
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
398
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)
396
Estimated Study Completion Date  ICMJE March 14, 2020
Actual Primary Completion DateAugust 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
  • Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
  • Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B vaccine.
  • Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
  • Contraindication to vaccination with any HAV vaccine or known latex allergy.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
  • History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
  • Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
  • Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
  • Current chronic use of systemic antibiotics.
  • Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
  • Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czechia,   Finland,   Poland
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT02534935
Other Study ID Numbers  ICMJE B1971035
2011-004400-38 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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]

Call Now