Archive · 7 Nov 2025
India's Expert Panel Seeks Stricter HPV Vaccine Trial Design
Imagine a new medicine that helps stop a disease called cervical cancer.
A company in India, called Serum Institute, made a vaccine called CERVAVAC to fight this disease.
The government has experts who make sure medicines are safe and work well before lots of people can use them.
They looked at the plan for testing the vaccine on older women, who can have children.
The experts said the plan needs to be better.
They want the company to ask clearer questions in the study and use stricter rules to see if CERVAVAC works just as well as another vaccine called Gardasil.
They also want the company to study how well the vaccine prevents certain types of infections for a longer time.
Collecting blood samples at different times will help them understand how the body fights the virus after the shots.
The company needs to make these changes and show the experts a new plan.
An expert committee has asked the Serum Institute of India (SII) to revise its Phase III trial protocol for the CERVAVAC HPV vaccine.
The proposed trial aims to test the vaccine in women aged 27 to 45 years, comparing it against Merck's Gardasil.
The committee seeks stronger objectives, including making the evaluation of immune response to HPV types 6 and 11 a primary goal.
Stricter scientific standards are required, including a higher threshold for proving non-inferiority and a statistical check on response rate differences.
The committee also recommended collecting blood samples before the third dose to better assess immunogenicity after two doses and compare it with the response after three doses.
- Who
- India's expert committee on vaccines and the Serum Institute of India (SII)
- What
- The expert committee has requested SII to revise its Phase III trial plan for the CERVAVAC cervical cancer vaccine before testing it on women aged 27-45.
- When
- November 7, 2025
- Where
- India
- Why
- To strengthen the trial design, tighten scientific criteria, and ensure robust evidence of the vaccine's efficacy and safety compared to Merck's Gardasil.
Serum Institute of India (Proposed Trial)
Expert Committee Recommendations
Primary Objective for HPV Types 6 & 11
Serum Institute of India (Proposed Trial)
To demonstrate non-inferiority of CERVAVAC's immune response to HPV types 6 and 11 as a secondary objective.
Expert Committee Recommendations
To establish the determination of immune response to HPV types 6 and 11 as a primary objective.
Assessment of Persistent HPV Infections
Serum Institute of India (Proposed Trial)
To consider protection against persistent HPV 6, 11, 16 and 18 infections as an exploratory objective.
Expert Committee Recommendations
To assess protection against incident persistent cervical HPV 6, 11, 16 and 18 infections as a secondary objective at 24 and 36 months.
Non-Inferiority Standard for Immune Response
Serum Institute of India (Proposed Trial)
Considers CERVAVAC 'not worse' than Gardasil if immune response is at least half as strong.
Expert Committee Recommendations
Recommends the standard be at least two-thirds as strong for non-inferiority.
Statistical Check for Response Rates
Serum Institute of India (Proposed Trial)
Did not include a specific statistical check for a 10% difference in response rates.
Expert Committee Recommendations
The company should include a statistical check ensuring the difference in response rates between the vaccines is not worse than 10%.
- Vaccine
- CERVAVAC (quadrivalent HPV vaccine)
- Developer
- Serum Institute of India (SII) in collaboration with the Department of Biotechnology
- Target Age Group (Proposed Trial)
- Women aged 27 to 45 Years
- Comparison Vaccine
- Merck's Gardasil
- Current Approval (CERVAVAC)
- Girls and young women aged 9 to 26 years
- Purpose
- Prevention of cervical cancer caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18