Behind Vaccine Development:
The Clinical Trial Process
Vaccine commercialization is a lengthy process that may often take10 years or longer.1

Developing vaccines requires special consideration
because vaccines:2• Are given to healthy individuals to help prevent diseaseand contribute to the health and well-being of society asa whole3• Demand a high safety threshold to achieve regulatory
authority approval• Are highly complex substances often derived from living
materials that require speciﬁc manufacturing processes• Require specialized testing to help assure quality andsafety of all vaccines distributed

How Are New Vaccines Developed?
The research and development cycle of avaccine includes: 4• Exploratory stage• Pre-clinical stage• Clinical development (Phases 1-3)
• Regulatory review and approval• Long-term clinical development (Phase 4)• Manufacturing• Quality control

What Are Clinical Trials?
Clinical Trials Also:• Provide important insight
into diseases and how they may
be prevented or treated 5

Clinical trials are research studies involving
human volunteers that often evaluate thesafety and eﬃcacy of preventative measuresor treatment products such as vaccines,medicines or medical devices.5• Are a critical step to support
the approval of vaccines ormedicines and medicaldevices by regulatory bodies6

How Are Trials Designed?

In order to produce the required data,clinical trials need to be designed based on
clear protocols for the conduct of the trial. 5,6

Studies vary in their endpoints,
the number of participants
involved, and the study design,
however, all clinical studies
follow criteria to protect theparticipants and ensure proper
evaluation of theinvestigational product.7

Certain types of human biases
have been shown to inﬂuence trial outcomes,
and the goal of randomizing and blinding is to minimize
this inﬂuence.8?

Randomization: 5

Double-blinding: 5

A method based on chance by whichstudy participants are assigned to
diﬀerent treatment groups.

A clinical trial design in which neither
the participating individuals nor thestudy staﬀ knows which participants
are receiving the experimental vaccine
and which are receiving a placebo or
another therapy.

Randomization avoids bias and allows
researchers to compare diﬀerent
treatments in similar groups.

What Happens During Clinical Trials?
Clinical development, in general,
is a three-phase process:
PHASE

PHASE

PHASE

First safety studies arecompleted in small
groups of healthy
volunteers.5

Study size is expanded and vaccine istested for safety and immunogenicity inpeople with characteristics (such as age
and physical health) similar to those forwhom the vaccine is intended.5

Vaccine is given to
thousands of people
and often tested forsafety and eﬃcacy.5

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Many vaccines also undergo long-term studies (Phase 4) after the vaccine is licensed
for ongoing monitoring of safety and eﬀectiveness.2,5A Leader In Vaccine Development
For more than 70 years, Takeda has supplied routine vaccines tohelp protect the health of the people of Japan. Today, Takeda isexpanding our global vaccine business by relying on innovation totackle some of the world’s most challenging infectious diseases, suchas dengue, COVID-19 and pandemic inﬂuenza.
Our mission is to develop and deliver innovative vaccines that tackle some of the mostchallenging problems in public health and help protect the health of people around the world.9References
1Centers for Disease Control and Prevention. Vaccine Safety: History of Vaccine Safety. 2020. Retrieved April 2024.
https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html.

2World Health Organization. Guidelines on clinical evaluation of vaccines: regulatory expectations. 2017. RetrievedApril 2024.

https://cdn.who.int/media/docs/default-source/prequal/vaccines/who-trs-1004-web-annex-9.pdf?sfvrsn=9c8f4704_2&download=true.

3

4

5

6

Rodrigues, Charlene M C, and Stanley A Plotkin. “Impact of Vaccines; Health, Economic and Social Perspectives.”
Frontiers in microbiology vol. 11 1526. 14 Jul. 2020, doi:10.3389/fmicb.2020.01526.
Centers for Disease Control and Prevention. Vaccines & Immunizations: Vaccine Testing and the Approval Process.
2023. Retrieved April 2024. https://www.cdc.gov/vaccines/basics/test-approve.html.
National Institutes of Health. NIH Clinical Research Trials and You. 2022. Retrieved April 2024.
https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics.
World Health Organization. Clinical evaluation of vaccines. Retrieved April 2024.

https://www.who.int/teams/health-product-policy-and-standards/standards-and-speciﬁcations/vaccine-standardization/clinical-evaluation-of-vaccines

7U.S. Department of Health and Human Services: Food and Drug Administration. E6(R2) Good Clinical Practice:Integrated Addendum to ICH E6(R1) Guidance for Industry. 2018. Retrieved April 2024.
https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf.

8

U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for Industry, E
10 Choice of Control Group and Related Issues in Clinical Trials. 2001. Retrieved April 2024.
https://www.fda.gov/media/71349/download.

9Takeda.com Our Pipeline. Retrieved April 2024.
https://www.takeda.com/what-we-do/research-and-development/our-pipeline/.
C-ANPROM/INT/VAC/0019 May 2024

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