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

Novartis

Status and phase: Completed; Phase 3

Conditions: Bacterial Meningitis

Treatments: Biological: Meningococcal ACWY conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547715

V59_43

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

MenACWY - 2 - 10 Years old

Experimental group

Description:

Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1.

Treatment:

Biological: Meningococcal ACWY conjugate vaccine

MenACWY - 11 - 18 Years old

Experimental group

Description:

Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.

Treatment:

Biological: Meningococcal ACWY conjugate vaccine

MenACWY - 19 - 75 Years old

Experimental group

Description:

Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.

Treatment:

Biological: Meningococcal ACWY conjugate vaccine