NCT03627507 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ahad M, Alim M
Current Challenges in Hepatitis B. TAJ: The Journal of Teachers Association RMC, Rajshahi. 2006; 19 (1):38-44
Bzowej NH
Hepatitis B Therapy in Pregnancy. Curr Hepat Rep. 2010 Nov;9(4):197-204. Epub 2010 Sep 9.
Ghosh, D
, Ghosh, C., Nath, M., Safwath, S., Saha, S., & Rowshon, A. (2018). Prevalence of anti-HBc total positivity in an impoverished Urban Community in Banglades. Bangladesh Medical Research Council Bulletin, 43(2), 63-70
Mahtab MA, Chaudhury M, Uddin MH, Noor-E Alam SM, Rahim MA, Alam MA, Moben AL, Khondaker FA, Choudhury MF, Sarkar MJ, Poddar PK, Foez SA, Akbar SM
Cost Assessment of Hepatitis B Virus-related Hepatitis in Bangladesh. Euroasian J Hepatogastroenterol. 2016
Mushahwar I
Viral Hepatitis: Molecular Biology, Diagnosis, Epidemiology, and Control. 1st ed. Amsterdam: Elsevier; 2004. Page 31, 79
WHO
EPI Fact Sheet. 2016. http://www.searo.who.int/entity/immunization/data/bangladesh. pdf [Accessed 27 Nov. 2017].
WHO
Hepatitis B Fact Sheet. 2017. http://www.who.int/mediacentre/factsheets/fs204/en/ [Accessed 27 Nov. 2017]

A Randomized Observer-blinded Non Inferiority Trial to Evaluate the Immunogenicity and Safety of Locally Manufactured Hepatitis B Vaccine 'Hepa B' in Bangladeshi Healthy Adults.

Details for clinical trial NCT03627507

Clinical trial NCT03627507 - References