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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001298303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
9/09/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public 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
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] 318316 0
SII-10vHPV-01
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Human Papilloma Virus (HPV) 343447 0
Condition category
Condition code
Infection 339539 339539 0 0
Sexually transmitted infections
Public Health 339746 339746 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention used in this study is called 10vHPV.

There are two phases in this study. Phase 1 will test 0.5mL single dose of 10vHPV on Day 1, in healthy participants. Phase 2 will test 0.5mL single dose of 10vHPV on Day 1, again at 2 months (Day 60), and again at 6 months (Day 180), in healthy participants. 10vHPV will be administered via intramuscular injection by trained unblinded study personnel.

The exact times of study vaccine administration and quantity of vaccine administered will be recorded in the participant's electronic case report form (eCRF). All participants will be given access to an eDiary and instructed to record any adverse events they experience.
Intervention code [1] 335211 0
Treatment: Drugs
Description of the comparator or control
The comparator used in this study is Gardasil 9.

In Phase 1, Gardasil 9 will be administered as a 0.5mL single dose on Day 1, in healthy participants. In Phase 2, Gardasil 9 will be administered as a 0.5mL single dose on Day 1, again at 2 months (Day 60), and again at 6 months (Day 180), in healthy participants. Gardasil 9 will be administered via intramuscular injection by trained unblinded study personnel.

The exact times of study vaccine administration and quantity of vaccine administered will be recorded in the participant's electronic case report form (eCRF). All participants will be given access to an eDiary and instructed to record any adverse events they experience.
Control group
Active

Outcomes
Primary outcome [1] 346721 0
Phase 1 Primary - To assess the safety 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.
Timepoint [1] 346721 0
60 minutes post dose, 7 day follow up period, and 30 day follow-up period
Primary outcome [2] 346728 0
Phase 2 Primary - To assess the composite outcome comprising safety and reactogenicity of 3 doses of 10vHPV vaccine in comparison with 3 doses of Gardasil 9 vaccine in healthy adults aged 26 to 45 years.
Timepoint [2] 346728 0
60 minutes, 7 days, and 30 days after each vaccination at 0, 2 months, and 6 months
Primary outcome [3] 347158 0
Phase 1 Primary - To assess the 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.
Timepoint [3] 347158 0
60 minutes post dose, 7 day follow up period, and 30 day follow-up period
Secondary outcome [1] 467170 0
Phase 1 Secondary - To assess the immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years
Timepoint [1] 467170 0
30 days after vaccination
Secondary outcome [2] 467171 0
Phase 1 Exploratory - To assess immune response 6 months after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.
Timepoint [2] 467171 0
6 months after vaccination
Secondary outcome [3] 467185 0
Phase 2 Secondary - To assess immune response 30 days after 3rd vaccination (Month 7) with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years
Timepoint [3] 467185 0
30 days after 3rd vaccination
Secondary outcome [4] 469217 0
Phase 1 Secondary - To assess the immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years
Timepoint [4] 469217 0
30 days after vaccination
Secondary outcome [5] 469218 0
Phase 1 Secondary - To assess the immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years
Timepoint [5] 469218 0
30 days after vaccination
Secondary outcome [6] 469219 0
Phase 1 Exploratory - To assess immune response 6 months after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.
Timepoint [6] 469219 0
6 months after vaccination
Secondary outcome [7] 469220 0
Phase 1 Exploratory - To assess immune response 6 months after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.
Timepoint [7] 469220 0
6 months after vaccination
Secondary outcome [8] 469221 0
Phase 2 Secondary - To assess immune response 30 days after 3rd vaccination (Month 7) with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years
Timepoint [8] 469221 0
30 days after 3rd vaccination
Secondary outcome [9] 469222 0
Phase 2 Secondary - To assess immune response 30 days after 3rd vaccination (Month 7) with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years
Timepoint [9] 469222 0
30 days after 3rd vaccination

Eligibility
Key inclusion criteria
- Phase 1 only: Males and females aged 18 to 25 years inclusive at Screening
- Phase 2 only: Males and females aged 26 to 45 years inclusive at Screening
- 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 48 hours (2 days) prior to Screening, and each day of vaccine administration
- Willing and able to comply with restrictions of nicotine use throughout the study (i.e. the use of any tobacco and nicotine products [e.g. patches, gum, vapes, etc.] is not permitted from within 48 hours [2 days] 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. Highly effective contraception for a male participant (and his female partner, if she is of childbearing potential) is define as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse up to 90 days after the last study visit, in accordance with the usual lifestyle of the participant, is also acceptable.
- 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. Highly effective contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the usual lifestyle of the participant, is also acceptable.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Phase 1 only: Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids [THC], barbiturates, benzodiazepines, gamma-hydroxybutyric acid [GHB], phenylcyclidine [PCP], cotinine and alcohol) at Screening and Day 1
- 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) less than or equal to 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 less than or equal to 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 (including vital signs or ECG) 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 (including 'soft' drugs e.g. cannabis products)
- 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 less than or equal to 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 greater than or equal to 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]). (For corticosteroids, this is prednisone greater than or equal to 0.5 mg/kg/day or equivalent. However, inhaled or topical steroids are permitted).
- 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 (1 standard drink contains 10 g alcohol equal to 285 mL of full-strength beer or 30 mL of spirits [40%] or 100 mL of wine [13%]) within 1 month 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)
Web-based randomisation, central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 2:1 ratio to receive either 10vHPV or Gardasil 9 in a double-blinded manner. The computer-generated randomisation list for study vaccine assignment will be generated before the start of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322878 0
Commercial sector/Industry
Name [1] 322878 0
Serum Institute of India Pvt. Ltd. (SIIPL)
Country [1] 322878 0
India
Primary sponsor type
Commercial sector/Industry
Name
Serum Institute of India Pvt. Ltd. (SIIPL)
Address
Country
India
Secondary sponsor category [1] 325803 0
Commercial sector/Industry
Name [1] 325803 0
Accelagen Pty Ltd
Address [1] 325803 0
Country [1] 325803 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321311 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 321311 0
Ethics committee country [1] 321311 0
Australia
Date submitted for ethics approval [1] 321311 0
01/07/2026
Approval date [1] 321311 0
Ethics approval number [1] 321311 0

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

Contacts
Principal investigator
Name 153318 0
Dr James Molton
Address 153318 0
Doherty Clinical Trials Limited, 2 St Andrews Place, East Melbourne, Victoria, Australia 3002
Country 153318 0
Australia
Phone 153318 0
+61 4 91478373
Fax 153318 0
Email 153318 0
[email protected]
Contact person for public queries
Name 153319 0
Nicola Byrne
Address 153319 0
Doherty Clinical Trials - 2 St Andrews Place, East Melbourne, Victoria, Australia 3002
Country 153319 0
Australia
Phone 153319 0
+61 03 9970 4200
Fax 153319 0
Email 153319 0
[email protected]
Contact person for scientific queries
Name 153320 0
James Molton
Address 153320 0
Doherty Clinical Trials Limited, 2 St Andrews Place, East Melbourne, Victoria, Australia 3002
Country 153320 0
Australia
Phone 153320 0
+61 4 91478373
Fax 153320 0
Email 153320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.