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
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.
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 →Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
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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.
Exclusion Criteria:
Biological: 10vHPV
Biological: Gardasil9
10vHPV is manufactured by Serum Institute of India Pvt. Ltd and is a 10-valent recombinant VLP vaccine containing the major capsid (L1) protein
Gardasil9 is manufactured by Merck Sharp \& Dohme (MSD) and is a 9-valent recombinant VLP vaccine containing the major capsid (L1) protein
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
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
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
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
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
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.
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 ↗
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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