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Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01547715
First received: February 23, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.


Condition Intervention Phase
Bacterial Meningitis
Biological: Meningococcal ACWY conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75 Years of Age in India.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y. [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y. [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • Safety profile following MenACWY-CRM vaccination in terms of percentage and number of subjects with: [ Time Frame: 29 Days ] [ Designated as safety issue: Yes ]
    • Local and systemic reactions reported from day 1 (day of vaccination) through day 7 post vaccination.
    • All other adverse events (AEs) reported from day 1 through day 7 postvaccination.
    • Serious adverse events (SAEs) and medically attended AEs from day 1 through day 29


Enrollment: 180
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY
All subjects will have blood drawn at day 1 and day 29 and will receive a single dose of Meningococcal ACWY conjugate vaccine
Biological: Meningococcal ACWY conjugate vaccine
All subjects will receive a single dose of Meningococcal ACWY conjugate vaccine

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals eligible for enrollment in this study are those:

  1. who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and:

    • the parent/legal representative has provided written informed consent (greater than or equal to 2 - less than 18 years of age).
    • have provided written assent (greater than or equal to 7-less than or equal to 18 years)
    • have provided written informed consent (greater than or equal to 18 to 75 years of age).
  2. who the investigator believes that they or their parents/legal representatives can and will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
  3. who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
  4. who have a negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

  1. who are unwilling or unable to give written informed assent or consent to participate in the study.
  2. who are perceived to be unreliable or unavailable for the duration of the study period.
  3. who had a previous or suspected disease caused by N. meningitidis.
  4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
  5. who have previously been immunized with a meningococcal vaccine.
  6. who have received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
  7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
  8. who have experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature greater than or equal to 38°C) within 3 days prior to enrollment.
  9. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
  10. who have epilepsy or any progressive neurological disease.
  11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
  12. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    • receipt of immunosuppressive therapy within 28 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose greater than 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or cancer chemotherapy)
    • receipt of immunostimulants
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study.
  13. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547715

Locations
India
Osmania Medical College Ethics Commitee, Niloufer Hospital
Hyderabad, Andrapradesh, India, 500004
Bharati Vidyapeeth University Institutional Ethics Commitee
Katraj, Dhankawadi, India, 411043
Padmasree Dr. D.Y Patil medical College
Pune, Maharashtra, India, 411018
Seth GS Medical College and KEM Hospital
Mumbai, Maharastra, India, 400012
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Principal Investigator: Dr. Sanjay Lalwani Bharati Hospital and Research Center
Principal Investigator: Dr. Nitya Gogtay Seth GS Medical College and KEM Hospital
Principal Investigator: Dr. A Amaresh Niloufer Hospital, Hyderabad
Principal Investigator: Dr. Sharad Agarkhedkar Padmasree Dr. D.Y.patil Medical College, Hospital & Research Center
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01547715     History of Changes
Other Study ID Numbers: V59_43
Study First Received: February 23, 2012
Last Updated: July 8, 2014
Health Authority: India: Central Drugs Standard Control Organization

Keywords provided by Novartis:
Meningococcal,
ACWY,
bacterial meningitis,
conjugate vaccine,
healthy, children,
adolescents,
adults,
India

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 23, 2014