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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07888686




Registration number
Help: Registration number
NCT07888686
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
26/09/2026
Date registered
Help: Date registered
22/10/2026
Date last updated
Help: Date last updated
6/11/2026

Titles & IDs
Public title
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Scientific title
A Phase 1/2, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine in Comparison With Gardasil 9 Vaccine in Healthy Adults
Additional trial identifiers [1] 0 0
SII-10vHPV-01
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Human Papillomavirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Other - 10vHPV
Treatment: Other - Gardasil9

Experimental: 10vHPV Vaccine -

Active comparator: Gardasil9 -


Treatment: Other: 10vHPV
10vHPV is manufactured by Serum Institute of India Pvt. Ltd and is a 10-valent recombinant VLP vaccine containing the major capsid (L1) protein

Treatment: Other: Gardasil9
Gardasil9 is manufactured by Merck Sharp \& Dohme (MSD) and is a 9-valent recombinant VLP vaccine containing the major capsid (L1) protein
Intervention code [1] 0 0
Treatment: Other
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and reactogenicity of a single dose of 10vHPV vaccine in comparison with a single dose of Gardasil 9 vaccine in healthy adults aged 18 to 25 years in phase 1.
Timepoint [1] 0 0
30 days after vaccination
Primary outcome [2] 0 0
To assess the safety of 3 doses (administered at day 0, 60 and 180) of 10vHPV vaccine in comparison with 3 doses (administered at day 0, 60 and 180) of Gardasil 9 vaccine in healthy adults aged 26 to 45 years.
Timepoint [2] 0 0
30 days after last dose
Secondary outcome [1] 0 0
To assess immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.
Timepoint [1] 0 0
30 days after vaccination
Secondary outcome [2] 0 0
To assess immune response 30 days after 3rd vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years.
Timepoint [2] 0 0
7 months

Eligibility
Key inclusion criteria
* Males and females aged 18 to 25 years inclusive at Screening (Phase 1 Only)
* Males and females aged 26 to 45 years inclusive at Screening (Phase 2 Only)
* Willing and able to sign an Informed Consent Form (ICF)
* Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator
* Participants willing and able to comply with the requirements of the Protocol
* Participants agree to refrain from strenuous exercise (including weightlifting) within 96 hours (4 days) prior to Screening, and each day of vaccine administration
* Willing and able to comply with restrictions of nicotine use throughout the study is not permitted from within 48 hours [2days] prior to Screening, from Day 1 until Day 8, and within 48 hours [2 days] prior to the end of study [EoS/early termination [ET} visit)
* Male participants, if not surgically sterilised or have partners of the same sex, must agree to use highly effective contraception and not plan a pregnancy or donate sperm from Day 1 until 90 days after the last study visit.
* Female participants of childbearing potential who have fertile male sexual partners must agree to use highly effective contraception from Day 1 until 90 days after the last study visit.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
* Positive drug and/or alcohol screen at Screening and Day 1 (Phase 1 Only)
* Are vaccinated against HPV
* History of HPV infection and associated medical conditions (confirmed either clinically, serologically, or microbiologically) including history of abnormal Papanicolau test, HPV DNA test, abnormal cervical biopsy,or external genital warts, as reported by the participant
* History of administration of any investigational or non-registered product (drug or vaccine) 30 days prior to study vaccine administration on Day 1 or plan to participate in another study with investigational drug or vaccine prior to Day 30
* Any vaccination received 30 days before Screening or plan to receive a vaccination between Screening and Day 30
* Pregnant or lactating females or females planning to become pregnant or beast feed during the study
* Any findings on medical examination deviating from normal and assessed as clinically relevant by the investigator
* A participant who has a body mass index (BMI) >35.0 kg/m2
* A participant who has skin markings in both deltoid areas, which prevents injection site reaction (ISR)assessment, in the opinion of the investigator
* History of alcohol abuse or drug addiction
* Positive screen for HBsAg, HBcAb, HCV antibodies, or HIV 1 and 2 antibodies
* History of a severe allergic reaction (e.g. anaphylaxis) after any vaccine or to any component (active substances or excipients) of the study vaccines
* History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment
* History of thrombocytopenia or a bleeding disorder following an IM injection
* History or current evidence of any condition or therapy which might interfere with the participant's participation for the full duration of the study, evidence of suspected diseases, or is not in the best interest of the participants to participate, in the opinion of the investigator
* History of major surgery =30 days prior to study vaccination on Day 1. If the participant has had any surgery >30 days prior to the study vaccination on Day 1, the participant can be enrolled in the study at the discretion of the investigator
* Acute illness (moderate or severe) and/or fever (tympanic) (temperature =38.0°C) at the time of vaccination or during the 72 hours prior to the vaccination on Visit 2 (Day 1) should be delayed until the participant is fully recovered and fever-free
* History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination, or planned receipt of blood products during the study period.
* Any confirmed or suspected congenital or acquired immunosuppressive, immunodeficient condition or autoimmune disease, based on medical history and physical examination.
* Family history of any medical conditions, that in the Investigator's opinion, could affect the trial outcomes.
* Chronic administration (defined as >14 days) of immunosuppressant or other immune modifying drugs(including topical calcineurin inhibitors) during the period starting 6 months prior to the study vaccine administration or planned during the study period up to Visit 4 (Day 30 [-2 to +14 days]).
* Any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would be scheduled.
* Employee of any organisation associated with this study.
* History of clinically relevant drug and/or food allergies.
* History of alcohol consumption of more than 10 standard drinks/week and no more than 4 standard drinks on any one day within 3 months prior to Screening.
* Any physical, psychological, mental and/or social reason which in the opinion of the Investigator makes the participant unsuitable for the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Doherty Clinical Trials Limited - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Serum Institute of India Pvt. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hitt Sharma
Address 0 0
Serum Institute of India Pvt. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hitt Sharma
Address 0 0
Country 0 0
Phone 0 0
+91-9822418354
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Summary Results

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
24 month after the study completion
Available to whom?
Researchers who provide a methodologically sound proposal may be provided the access afterSponsor permission and if signed data-access agreements are in place.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07888686