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Not yet recruitingNCT07888686Updated Oct 22, 2026

Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine

A Phase 1/2 interventional study of 10vHPV and Gardasil9 in Human Papillomavirus Infection, sponsored by Serum Institute of India Pvt. Ltd.. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Serum Institute of India Pvt. Ltd. · Phase 1/2, Interventional, and Prevention

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study summary

Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. This study will assess an experimental vaccine called 10 valent Human Papillomavirus Virus (10vHPV) for the safety, reactivity, and immune response, in healthy adults, compared to Gardasil 9.

There are two phases in this study - Phase 1 will include up to 36 healthy adults aged 18-25 years, Phase 2 will include 36 healthy adults aged 26-45 years. Participants will be randomised in a 2-to-1 ratio to receive either 10vHPV or Gardasil 9.

10vHPV or Gardasil 9 will be administered as a 0.5 mL single dose via intramuscular injection in the deltoid muscle of the upper arm. In Phase 1, participants will receive a single dose on Day 1, and in Phase 2, participants will receive a single dose on Day 1, 2 months, and 6 months.

02

Conditions studied

  • Human Papillomavirus Infection

Keywords

  • HPV
  • Vaccine
03

In context

Papillomavirus Infections

505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.

This study's planned enrollment of 72 is below the median of 202 across 338 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.

Exclusion criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    10vHPV Vaccine

    Biological: 10vHPV

  • Active comparator
    Gardasil9

    Biological: Gardasil9

Interventions

  • Biological10vHPV

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

  • BiologicalGardasil9

    Gardasil9 is manufactured by Merck Sharp \& Dohme (MSD) and is a 9-valent recombinant VLP vaccine containing the major capsid (L1) protein

06

What researchers measure

Primary outcomes

  1. 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.

    The incidence, severity and relationship of solicited AEs during 7-day, unsolicited and serious adverse events during 30-day follow-up period after administration of a single dose.

    Time frame: 30 days after vaccination

  2. 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.

    The incidence, severity and relationship of solicited AEs during 7-day after each vaccine dose, unsolicited and serious adverse events up to 30 days after the last dose .

    Time frame: 30 days after last dose

Secondary outcomes

  1. To assess immune response 30 days after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.

    Percentage of participants achieving seroconversion, Geometric mean titres (GMTs) for anti-HPV antibodies, Geometric mean fold rise (GMFR) on Day 30.

    Time frame: 30 days after vaccination

  2. To assess immune response 30 days after 3rd vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 26 to 45 years.

    Percentage of participants achieving seroconversion, GMTs for anti-HPV antibodies and GMFR on Day 30 post 3rd dose (Month 7)

    Time frame: 7 months

Other outcomes

  1. To assess immune response 6 months after vaccination with 10vHPV vaccine compared to Gardasil 9 in healthy adults aged 18 to 25 years.

    Percentage of participants achieving seroconversion, GMTs for anti-HPV antibodies, GMFR at Month 6

    Time frame: 6 month

07

Study locations

1 site
  • Doherty Clinical Trials Limited
    East Melbourne, Victoria 3002, Australia
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References and documents

Individual participant data

Plan to share: Yes — Summary Results

Supporting information: Study protocol

Time frame: 24 month after the study completion

Access criteria: Researchers who provide a methodologically sound proposal may be provided the access afterSponsor permission and if signed data-access agreements are in place.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888686
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Hitt Sharma
Contact
drhjs@seruminstitute.com
+91-9822418354
Sameer Parekh
Contact
sameer.parekh@seruminstitute.com
+91-9226722745
Hitt Sharma
study director · Serum Institute of India Pvt. Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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