Cervical CancerPhase 4NCT00923702

Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

A Phase 4 study testing Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) in people with Cervical Cancer and Cervical Precancerous Lesions, run by Partha Basu at 8 sites in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen would offer similar immunogenicity and protection as that of a three-dose regimen to girls against persistent HPV infection and cervical neoplasia caused by HPV types included in the vaccine. Read more about this study

Who is it for?: Ages 10 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Cervical Precancerous Lesions
What is being tested?: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22,729 participants
Where: 8 sitesIndia
Study dates: Sep 2009to Jul 2026
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 18 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Apparently healthy, ambulant girls aged 10 - 18 years
Unmarried girls
Girls with intact uterus
Resident in the villages chosen for the study

Who cannot join

Girls with any severe and/or debilitating illness
Past history of allergy to any medication

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

India8 sites

Gujarat Cancer & Research Institute (GCRI)
Ahmedabad, Gujarat, 380 016
Christian Fellowship Community Health Centre
Ambilikkai, Tamil Nadu, 624612
Tata Memorial Centre Rural Cancer Project, Nargis Dutt Memorial Cancer Hospital
Barshi, Maharashtra, 413 401
MNJ Institute of Oncology & Regional Cancer Center
Hyderabad, Andhra Pradesh, 500004
Cancer Foundation of India
Kolkata, West Bengal, 700031
Tata Memorial Center, Tata Memorial Hospital & Cancer Research Inst
Mumbai, Maharashtra, 400 012
All India Institute of Medical Sciences
New Delhi, 110029
Jehangir Clinical Development Centre (JCDC) Pvt. Ltd.
Pune, Maharashtra, 411 001

Other trials in India

About this study

Official title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India

Read the detailed description

The suspension of vaccination resulted in girls receiving 3 doses (days 1, 60 and ≥180), receiving 2 doses (days 1 and ≥180), receiving 2 doses at days 1 and 60 due to incomplete treatment ("by default"), and receiving one dose by default. A first age and site-matched cohort of unvaccinated married women was recruited, starting in May 2012 to serve as the unvaccinated control group of women for the analysis of HPV incidence and persistence outcomes. A second age and site-matched (age and site matched to the vaccinated women undergoing screening) cohort of unvaccinated married women is being recruited starting in June 2017 and is to be used in addition to the first unvaccinated cohort for the assessment of the cervical neoplasia outcome.

Conditions: Cervical Cancer, Cervical Precancerous Lesions
Being tested: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)Biological
Also called Gardasil®
The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.

Study groups in NCT00923702
Study group	Role	What they receive
3-dose	Active comparator	The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+. Receives: Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
2-dose	Experimental	The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+. Receives: Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
2 doses by default	Experimental	The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses) Receives: Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Single-dose	Experimental	The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses) Receives: Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Unvaccinated	No intervention	A cohort of unvaccinated women

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points
Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA.
Measured: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48
Frequency of Persistent HPV 16/18/6/11 Infection.
The first cervical cell samples were collected from women 18 months after married or 6 months after the first delivery. After that, 3 extra annual collections were obtained. The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
Measured: From date of marriage through to 7 years of follow-up
Frequency of HPV 16/18-associated Precancerous Lesions and Cancer.
Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of HPV 16 and/or HPV 18 by PCR in the same biopsy tissue sample.
Measured: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen

Secondary outcomes (2)

Frequency of Infection by Other Non-targeted High-risk HPV Types.
The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
Measured: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen
Frequency of Cervical Neoplasia Associated With Non-included HPV Types.
Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of other non vaccine included HPV types by PCR in the same biopsy tissue sample.
Measured: 15 years from the base-line date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jul 2026

First posted18 Jun 2009 (estimated)
Study startSep 2009
Primary completionJan 2017
Study completionJul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22,729 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00923702
Sponsor's protocol ID: BMGF48979
Other IDs: ISRCTN98283094, REFCTRI-2009 000137
Status last verified: Sep 2023
First submitted: 17 Jun 2009
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Basu P, Malvi SG, Joshi S, Bhatla N, Muwonge R, Lucas E, Verma Y, Esmy PO, Poli URR, Shah A, Zomawia E, Pimple S, Jayant K, Hingmire S, Chiwate A, Divate U, Vashist S, Mishra G, Jadhav R, Siddiqi M, Sankaran S, Prabhu PR, Kannan TPRA, Varghese R, Shastri SS, Anantharaman D, Gheit T, Tommasino M, Sauvaget C, Pillai MR, Sankaranarayanan R. Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1518-1529. doi: 10.1016/S1470-2045(21)00453-8. Epub 2021 Oct 8.
PubMed 34634254
Sankaranarayanan R, Prabhu PR, Pawlita M, Gheit T, Bhatla N, Muwonge R, Nene BM, Esmy PO, Joshi S, Poli UR, Jivarajani P, Verma Y, Zomawia E, Siddiqi M, Shastri SS, Jayant K, Malvi SG, Lucas E, Michel A, Butt J, Vijayamma JM, Sankaran S, Kannan TP, Varghese R, Divate U, Thomas S, Joshi G, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Hingmire S, Kriplani A, Mishra G, Pimple S, Jadhav R, Sauvaget C, Tommasino M, Pillai MR; Indian HPV Vaccine Study Group. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016 Jan;17(1):67-77. doi: 10.1016/S1470-2045(15)00414-3. Epub 2015 Dec 2.
PubMed 26652797
Sankaranarayanan R, Joshi S, Muwonge R, Esmy PO, Basu P, Prabhu P, Bhatla N, Nene BM, Shaw J, Poli URR, Verma Y, Zomawia E, Pimple S, Tommasino M, Pawlita M, Gheit T, Waterboer T, Sehr P, Pillai MR; Indian HPV vaccine study group. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. doi: 10.1016/j.vaccine.2018.02.087. Epub 2018 Mar 15.
PubMed 29551226
Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Pimple S, Prabhu PR, Basu P, Muwonge R, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Kannan TPRA, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Kriplani A, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. doi: 10.1016/j.pvr.2018.03.008. Epub 2018 Mar 22.
PubMed 29578097
Basu P, Muwonge R, Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Shastri SS, Pimple S, Anantharaman D, Prabhu PR, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Rameshwari Ammal Kannan TP, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Vashist S, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow-up cohort study. Papillomavirus Res. 2019 Jun;7:75-81. doi: 10.1016/j.pvr.2019.01.004. Epub 2019 Jan 31.
PubMed 30711698
Muwonge R, Basu P, Gheit T, Anantharaman D, Verma Y, Bhatla N, Joshi S, Esmy PO, Poli URR, Shah A, Zomawia E, Shastri SS, Pimple S, Prabhu PR, Hingmire S, Chiwate A, Sauvaget C, Lucas E, Malvi SG, Siddiqi M, Sankaran S, Kannan TPRA, Varghese R, Divate U, Vashist S, Mishra G, Jadhav R, Tommasino M, Pillai MR, Sankaranarayanan R, Jayant K; Indian HPV vaccine study group. Acquisition, prevalence and clearance of type-specific human papillomavirus infections in young sexually active Indian women: A community-based multicentric cohort study. PLoS One. 2020 Dec 29;15(12):e0244242. doi: 10.1371/journal.pone.0244242. eCollection 2020.
PubMed 33373380
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
ClinicalTrials.gov ID: NCT00923702
Acronym / sponsor ID: BMGF48979
Conditions: Cervical Cancer, Cervical Precancerous Lesions
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 22,729 participants (actual)
Lead sponsor: Partha BasuUniversity, hospital or other
Collaborators: All India Institute of Medical Sciences, Cancer Foundation of India, Christian Fellowship Community Health Centre, German Cancer Research Center, Gujarat Cancer & Research Institute, Jehangir Clinical Development Centre, MNJ Institute of Oncology and Regional Cancer Center, Rajiv Gandhi Centre for Biotechnology, Nargis Datta Memorial Cancer Hospital, Tata Memorial Centre
Study start: Sep 2009 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Jul 2026 (estimated)
First posted: 18 Jun 2009 (estimated)
Results: Posted 20 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
3-dose	Active comparator	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
2-dose	Experimental	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
2 doses by default	Experimental	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Single-dose	Experimental	Biological: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Unvaccinated	No intervention	–A cohort of unvaccinated women

Who may qualify

Ages: 10 to 18 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Apparently healthy, ambulant girls aged 10 - 18 years
Unmarried girls
Girls with intact uterus
Resident in the villages chosen for the study

Key exclusion criteria (2 listed)

Girls with any severe and/or debilitating illness
Past history of allergy to any medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)Also: Gardasil®The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.	Biological	2 doses by default, 2-dose, 3-dose, Single-dose

Primary outcome

Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points
Time frame: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48
Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA.
Frequency of Persistent HPV 16/18/6/11 Infection.
Time frame: From date of marriage through to 7 years of follow-up
The first cervical cell samples were collected from women 18 months after married or 6 months after the first delivery. After that, 3 extra annual collections were obtained. The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
Frequency of HPV 16/18-associated Precancerous Lesions and Cancer.
Time frame: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen
Pathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of HPV 16 and/or HPV 18 by PCR in the same biopsy tissue sample.

2 secondary outcomes

Frequency of Infection by Other Non-targeted High-risk HPV Types.
Time frame: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen
Frequency of Cervical Neoplasia Associated With Non-included HPV Types.
Time frame: 15 years from the base-line date

Results and safety

Results posted to the registry on 20 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3-dose	4,348	4,348
2-dose	4,979	4,979
2 Doses by Default	3,452	3,452
Single-dose	4,950	4,950
Unvaccinated	5,000	4,646

Primary outcome: Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points

Time frame: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48. Geometric mean (95% Confidence Interval). Unit: median flow intensities

Measure	3-dose n = 308	2-dose n = 317	2 Doses by Default n = 471	Single-dose n = 528	Unvaccinated n = 0
Value	5460 (5195 to 5738)	6125 (5785 to 6485)	437 (398 to 480)	106 (96 to 116)	–

3-dose vs 2-dose vs 2 Doses by Default vs Single-dose: Risk Ratio (RR): 0.5, Regression, Linear

Population analysed: Data used for this outcome are from a subset of participants that had their immunogeneicity samples tested in the laboratory. We are indicating the total of HPV 16 L1 antibodies of the HPV 16 L1 antiboties at month 7 for the 3-dose and 2-dose groups and at month 12 for the 2 doses by default and single-dose groups. No immunogeneity data was collected from the unvaccinated cohort as it was recruited adhoc to assess the HPV infections and CIN endpoints.

Primary outcome: Frequency of Persistent HPV 16/18/6/11 Infection.

Time frame: From date of marriage through to 7 years of follow-up. Number. Unit: Infections

Measure	3-dose n = 1460	2-dose n = 1452	2 Doses by Default n = 1626	Single-dose n = 2135	Unvaccinated n = 1265
Value	1	1	4	1	32

3-dose vs 2-dose vs 2 Doses by Default vs Single-dose vs Unvaccinated: Vaccine efficacy: 95

Population analysed: Participants with at least two cervical cell sample collections, that were collected at least 10 months apart.

Primary outcome: Frequency of HPV 16/18-associated Precancerous Lesions and Cancer.

Time frame: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screen

The sponsor has not posted figures for this outcome.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3-dose	125 of 4,348 (2.9%)	637 of 4,348 (14.7%)	30 of 4,348
2-dose	135 of 4,979 (2.7%)	614 of 4,979 (12.3%)	22 of 4,979
2 Doses by Default	292 of 3,452 (8.5%)	614 of 3,452 (17.8%)	38 of 3,452
Single-dose	356 of 4,950 (7.2%)	296 of 4,950 (6%)	45 of 4,950
Unvaccinated	0 of 4,646 (0%)	0 of 4,646 (0%)	9 of 4,646

Limitations and caveats (from the sponsor): Because of the suspension of all HPV vaccine studies for reasons not related to this trial, the study was able to recruit 17729 of the originally planned 20000 participants some of who received less than the originally planned vaccine dose schedule.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34634254Basu P, Malvi SG, Joshi S, Bhatla N, Muwonge R, Lucas E, Verma Y, Esmy PO, Poli URR, Shah A, Zomawia E, Pimple S, Jayant K, Hingmire S, Chiwate A, Divate U, Vashist S, Mishra G, Jadhav R, Siddiqi M, Sankaran S, Prabhu PR, Kannan TPRA, Varghese R, Shastri SS, Anantharaman D, Gheit T, Tommasino M, Sauvaget C, Pillai MR, Sankaranarayanan R. Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at 10 years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1518-1529. doi: 10.1016/S1470-2045(21)00453-8. Epub 2021 Oct 8.
Results publication: PubMed 26652797Sankaranarayanan R, Prabhu PR, Pawlita M, Gheit T, Bhatla N, Muwonge R, Nene BM, Esmy PO, Joshi S, Poli UR, Jivarajani P, Verma Y, Zomawia E, Siddiqi M, Shastri SS, Jayant K, Malvi SG, Lucas E, Michel A, Butt J, Vijayamma JM, Sankaran S, Kannan TP, Varghese R, Divate U, Thomas S, Joshi G, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Hingmire S, Kriplani A, Mishra G, Pimple S, Jadhav R, Sauvaget C, Tommasino M, Pillai MR; Indian HPV Vaccine Study Group. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016 Jan;17(1):67-77. doi: 10.1016/S1470-2045(15)00414-3. Epub 2015 Dec 2.
Results publication: PubMed 29551226Sankaranarayanan R, Joshi S, Muwonge R, Esmy PO, Basu P, Prabhu P, Bhatla N, Nene BM, Shaw J, Poli URR, Verma Y, Zomawia E, Pimple S, Tommasino M, Pawlita M, Gheit T, Waterboer T, Sehr P, Pillai MR; Indian HPV vaccine study group. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. doi: 10.1016/j.vaccine.2018.02.087. Epub 2018 Mar 15.
Results publication: PubMed 29578097Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Pimple S, Prabhu PR, Basu P, Muwonge R, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Kannan TPRA, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Kriplani A, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. doi: 10.1016/j.pvr.2018.03.008. Epub 2018 Mar 22.
Results publication: PubMed 30711698Basu P, Muwonge R, Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Shastri SS, Pimple S, Anantharaman D, Prabhu PR, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Rameshwari Ammal Kannan TP, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Vashist S, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow-up cohort study. Papillomavirus Res. 2019 Jun;7:75-81. doi: 10.1016/j.pvr.2019.01.004. Epub 2019 Jan 31.
Results publication: PubMed 33373380Muwonge R, Basu P, Gheit T, Anantharaman D, Verma Y, Bhatla N, Joshi S, Esmy PO, Poli URR, Shah A, Zomawia E, Shastri SS, Pimple S, Prabhu PR, Hingmire S, Chiwate A, Sauvaget C, Lucas E, Malvi SG, Siddiqi M, Sankaran S, Kannan TPRA, Varghese R, Divate U, Vashist S, Mishra G, Jadhav R, Tommasino M, Pillai MR, Sankaranarayanan R, Jayant K; Indian HPV vaccine study group. Acquisition, prevalence and clearance of type-specific human papillomavirus infections in young sexually active Indian women: A community-based multicentric cohort study. PLoS One. 2020 Dec 29;15(12):e0244242. doi: 10.1371/journal.pone.0244242. eCollection 2020.
Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Partha Basu, MD principal investigator

International Agency for Research on Cancer

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) in people with Cervical Cancer and Cervical Precancerous Lesions, run by Partha Basu at 8 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points (time frame: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00923702, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.