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

NCT01547715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-10-09

Study results available
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Summary

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.

Conditions

  • Bacterial Meningitis

Interventions

BIOLOGICAL

Meningococcal ACWY conjugate vaccine

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Dr. Sanjay Lalwani · Bharati Hospital and Research Center

  • Dr. Nitya Gogtay · Seth GS Medical College and KEM Hospital

  • Dr. A Amaresh · Niloufer Hospital, Hyderabad

  • Dr. Sharad Agarkhedkar · Padmasree Dr. D.Y.patil Medical College, Hospital & Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547715 on ClinicalTrials.gov