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

NCT ID: NCT01423084

Last Updated: 2015-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

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).

Conditions

Meningococcal Disease; Meningococcal Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MenB Lot 1

MenB vaccine Lot 1: 2 doses administered 1 month apart

Group Type: EXPERIMENTAL

Serogroup B meningococcal vaccine

Intervention Type: BIOLOGICAL

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 2

MenB vaccine Lot 2: 2 doses administered 1 month apart

Group Type: ACTIVE_COMPARATOR

Serogroup B meningococcal vaccine

Intervention Type: BIOLOGICAL

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

Interventions

Serogroup B meningococcal vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

SKDS Research Inc, 221-679 Davis Dr.Newmarket

Toronto, Ontario, Canada

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

Toronto, Ontario, Canada

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

Woodstock, Ontario, Canada

Countries

Australia; Canada

References

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.

Reference Type: DERIVED

PMID: 26232542 (View on PubMed)

Other Identifiers

V72_41

Identifier Type: -

Identifier Source: org_study_id