Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Novartis344 enrolled

Overview

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.

Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

344

Conditions

Meningococcal Disease Meningococcal Meningitis

Interventions

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (13)

Royal Children's Hospital

Herston, Queensland, Australia

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

Kippa-Ring, Queensland, Australia

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

Sherwood, Queensland, Australia

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

North Adelaide, South Australia, Australia

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

Melbourne, Victoria, Australia

Telethon Institute for Child Heath Research-cnr

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

TASC Research Services, 1-15243 91st Avenue

Surrey, British Columbia, Canada

Colchester Regional Hospital Colchester Research Group, 68 Robie Street

Truro, Nova Scotia, Canada

Albion Finch Medical Centre, 1620 Albion Road, Suite 106

Etobicoke, Ontario, Canada

Medicor Research Inc, 359 Riverside, Suite 200

Greater Sudbury, Ontario, Canada

...and 3 more locations

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: One month after the second vaccination (day 61)

Secondary Outcomes

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

The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group

Time frame: One month after the second vaccination (day 61)

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

The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).

Time frame: One month after the second vaccination (day 61)

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

The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).

Time frame: One month after the second vaccination (day 61)

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

The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.