Status:
COMPLETED
Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Incepta Vaccine Limited
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Quadri Meningo on a total of 88 heal...
Detailed Description
Protocol Title: A randomized observer-blinded controlled non-inferiority trial to evaluate the immunogenicity of locally manufactured Meningococcal ACWY vaccine 'Ingovax ACWY' in Bangladeshi healthy a...
Eligibility Criteria
Inclusion
- Apparently healthy adult of 18 to 45 years of age.
- Sex: Male, Female and Transgender
- Apparently healthy based on a medical history taken prior to vaccination. Any underlying chronic illness must be documented to be in stable condition.
- Women with child bearing potential must be non pregnant which will be confirmed by negative urine pregnancy test during screening and prior to vaccination on day 0 as well. Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely exclude the probability of pregnancy.Women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable.
Exclusion
- Prior history of Meningitis infection or vaccination with any Meningococcal vaccine.
- Prior history of taking any other polysaccharide vaccine (Pneumococcal Vaccine, Typhoid Vaccine) in last 6 months.
- Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
- Recent febrile illness (within last two weeks).
- Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician.
- Known or suspected hypersensitivity to any component of Meningococcal ACWY polysaccharide vaccine.
- Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g, systemic corticosteroids). Does not include topical and inhaled steroids.
- Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03263403
Start Date
August 21 2017
End Date
March 19 2018
Last Update
March 22 2018
Active Locations (1)
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1
Mohiul Islam Chowdhury
Dhaka, Bangladesh, 1212