The CT-clinical trial is needed in the vaccine production process to ensure the safety, quality and efficacy of the product. The clinical trial was divided into three stages. Phase I clinical trials to determine product safety and side effects. Phase II clinical test to find out and evaluate the immune response by increasing the number of respondents larger. Phase III clinical test to determine the level of efficacy of a vaccine with a predetermined subject. Bio Farma together with the Food and Drug Supervisory Agency (BPOM) conducted a series of vaccine manufacturing processes monitored by regulations on how to make a good drug or called the CPOB standard, also known as Good Manufacturing Practice (GMP) so that good quality products. Each batch produced must pass quality control, and guarantee quality (quality assurance).
BPOM guarantees that each batch of products produced has been reported and examined. If it passes the supervision test, BPOM will issue a certificate to pass the test for each batch of vaccine as a guarantee of product safety and quality. After a new vaccine product is launched into the market, a phase IV clinical trial is conducted to assess the effectiveness of the vaccine.