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

February 23, 2012
July 8, 2014
March 2012
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01547715 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Bacterial Meningitis
Biological: Meningococcal ACWY conjugate vaccine
All subjects will receive a single dose of Meningococcal ACWY conjugate vaccine
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
Intervention: Biological: Meningococcal ACWY conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01547715
V59_43
No
Novartis
Novartis
Novartis Vaccines
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
Novartis
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP