Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

August 21, 2017

Primary Completion Date

March 19, 2018

Study Completion Date

March 19, 2018

Conditions
Meningococcal Vaccine
Interventions
BIOLOGICAL

Ingovax ACWY

The pharmaceutical company in Bangladesh is now currently marketing meningococcal vaccine of Yuxi Walvax Biotechnology Co. Ltd which is filled finish by Incepta Vaccines Ltd. This fill finish meningococcal vaccine is already registered and licensed in Bangladesh. However, at present, no locally produced meningococcal vaccine is available in Bangladesh. Once this clinical trial is completed, it will then proceed for registration and licensure in Bangladesh. Ingovax ACWY is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.

BIOLOGICAL

Quadri Meningo

Meningococcal polysaccharide vaccine Quadri Meningo vaccine manufactured by BiO-MeD Private Limited. Quadri Meningo \[Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined\] is a freeze-dried preparation of the Group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y, and Group W-135. After reconstitution with diluent, the vaccine is a clear colourless liquid.

Trial Locations (1)

1212

Mohiul Islam Chowdhury, Dhaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incepta Vaccine Limited

UNKNOWN

lead

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER