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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MenACWY - 2 - 10 Years old

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

Group Type EXPERIMENTAL

Meningococcal ACWY conjugate vaccine

Intervention Type BIOLOGICAL

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

MenACWY - 11 - 18 Years old

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

Group Type EXPERIMENTAL

Meningococcal ACWY conjugate vaccine

Intervention Type BIOLOGICAL

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

MenACWY - 19 - 75 Years old

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

Group Type EXPERIMENTAL

Meningococcal ACWY conjugate vaccine

Intervention Type BIOLOGICAL

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Interventions

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Meningococcal ACWY conjugate vaccine

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes