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Completed

NCT Number: NCT01423084

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

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.

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Key information

Conditions

Meningococcal Disease Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Meningococcal Meningitis Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Children's Hospital, Herston, Queensland, Australia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serogroup B meningococcal vaccine

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

Primary outcomes

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

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

    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).

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

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

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

Secondary outcomes

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

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

    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

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

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

    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).

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

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

    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).

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

    Time frame: Two weeks after the second vaccination (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.

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

    Time frame: Two weeks after the second vaccination (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.

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

    Time frame: Two weeks after the second vaccination (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.

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

    Time frame: Two weeks after the second vaccination (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.

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

    Time frame: Two weeks after the second vaccination (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).

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

    Time frame: From day 1 to day 7 after any vaccination

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

  10. Number of Subjects Reporting Unsolicited AEs

    Time frame: From day 1 to day 7 after any vaccination.

    Number of subjects reporting any Unsolicited AEs after any vaccination.

  11. Number of Subjects Reporting SAEs and AE Leading to Withdrawal

    Time frame: Throughout the study period.

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2011
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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