NCT01423084

Brief Summary

The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

August 23, 2011

Results QC Date

February 3, 2015

Last Update Submit

February 3, 2015

Conditions

Meningococcal DiseaseMeningococcal Meningitis

Keywords

Meningococcal Meningitisprevention, vaccinationadolescents

Outcome Measures

Primary Outcomes (2)

  • Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.

    Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).

    One month after the second vaccination (day 61)

  • ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953

    The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.

    One month after the second vaccination (day 61)

Secondary Outcomes (11)

  • Percentage of Subjects in Each Lot With hSBA ≥ 1:5

    One month after the second vaccination (day 61)

  • Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.

    One month after the second vaccination (day 61)

  • Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953

    One month after the second vaccination (day 61)

  • hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.

    Two weeks after the second vaccination (day 45)

  • GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.

    Two weeks after the second vaccination (day 45)

  • +6 more secondary outcomes

Study Arms (2)

MenB Lot 1

EXPERIMENTAL

MenB vaccine Lot 1: 2 doses administered 1 month apart

Biological: Serogroup B meningococcal vaccine

MenB Lot 2

ACTIVE COMPARATOR

MenB vaccine Lot 2: 2 doses administered 1 month apart

Biological: Serogroup B meningococcal vaccine

Interventions

Serogroup B meningococcal vaccineBIOLOGICAL

All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2. A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination

MenB Lot 1MenB Lot 2

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
  • who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period)
  • in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

You may not qualify if:

  • History of any serogroup B meningococcal vaccination
  • Current or previous, confirmed or suspected disease caused by N. meningitidis
  • Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
  • Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
  • Antibiotic use within 3 days (72 hours) prior to enrollment
  • Pregnancy or nursing (breastfeeding) mothers
  • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
  • Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
  • Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
  • History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Royal Children's Hospital

Herston, Queensland, 4029, Australia

Location

AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre

Kippa-Ring, Queensland, 4021, Australia

Location

AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street

Sherwood, Queensland, 4075, Australia

Location

Women's and Children's Hospital, 72 King William Road

North Adelaide, South Australia, 5006, Australia

Location

Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Telethon Institute for Child Heath Research-cnr

Hamilton Street and Roberts Road-Subiaco, Western Australia, 6008, Australia

Location

TASC Research Services, 1-15243 91st Avenue

Surrey, British Columbia, V3R 8P8, Canada

Location

Colchester Regional Hospital Colchester Research Group, 68 Robie Street

Truro, Nova Scotia, B2N 1L2, Canada

Location

Albion Finch Medical Centre, 1620 Albion Road, Suite 106

Etobicoke, Ontario, M9V 4B4, Canada

Location

Medicor Research Inc, 359 Riverside, Suite 200

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

SKDS Research Inc, 221-679 Davis Dr.Newmarket

Toronto, Ontario, L3Y 5G8, Canada

Location

Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540

Toronto, Ontario, M5G 1N8, Canada

Location

Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301

Woodstock, Ontario, N4S 5P5, Canada

Location

Related Publications (1)

  • Perrett KP, McVernon J, Richmond PC, Marshall H, Nissen M, August A, Percell S, Toneatto D, Nolan T. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study. Vaccine. 2015 Sep 22;33(39):5217-24. doi: 10.1016/j.vaccine.2015.06.103. Epub 2015 Jul 29.

    PMID: 26232542DERIVED

MeSH Terms

Conditions

Meningococcal InfectionsMeningitis, Meningococcal

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningitis, BacterialCentral Nervous System Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Limitations and Caveats

None reported

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines
RegistryContactVaccinesUS@novartis.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 20, 2015

Results First Posted

February 20, 2015

Record last verified: 2015-02

Locations

AU(6)CA(7)