Back to results

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

Primary Purpose

Meningococcal Disease, Meningococcal Meningitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Serogroup B meningococcal vaccine

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal Meningitis, prevention, vaccination, adolescents

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Royal Children's Hospital
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
Women's and Children's Hospital, 72 King William Road
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne
Telethon Institute for Child Heath Research-cnr
TASC Research Services, 1-15243 91st Avenue
Colchester Regional Hospital Colchester Research Group, 68 Robie Street
Albion Finch Medical Centre, 1620 Albion Road, Suite 106
Medicor Research Inc, 359 Riverside, Suite 200
SKDS Research Inc, 221-679 Davis Dr.Newmarket
Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540
Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MenB Lot 1

MenB Lot 2

Arm Description

MenB vaccine Lot 1: 2 doses administered 1 month apart

MenB vaccine Lot 2: 2 doses administered 1 month apart

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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

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).

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).

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.

GMRs of 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 GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination.

Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.

The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.

ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.

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

GMR of ELISA GMCs Against Antigen 287-953 at Day 45.

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 45 vs baseline).

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)

Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.

Number of Subjects Reporting Unsolicited AEs

Number of subjects reporting any Unsolicited AEs after any vaccination.

Number of Subjects Reporting SAEs and AE Leading to Withdrawal

Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.

Full Information

NCT ID

NCT01423084

First Posted

August 23, 2011

Last Updated

February 3, 2015

Sponsor

Novartis

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01423084

Brief Title

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

Official Title

A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

Collaborators

Novartis Vaccines

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease, Meningococcal Meningitis

Keywords

Meningococcal Meningitis, prevention, vaccination, adolescents

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

344 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MenB Lot 1

Arm Type

Experimental

Arm Description

MenB vaccine Lot 1: 2 doses administered 1 month apart

Arm Title

MenB Lot 2

Arm Type

Active Comparator

Arm Description

MenB vaccine Lot 2: 2 doses administered 1 month apart

Intervention Type

Biological

Intervention Name(s)

Serogroup B meningococcal vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

One month after the second vaccination (day 61)

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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)

Title

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

Description

Time Frame

One month after the second vaccination (day 61)

Title

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

Description

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)

Title

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

Description

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.

Time Frame