Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India
| ISRCTN | ISRCTN98283094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98283094 |
| ClinicalTrials.gov (NCT) | NCT00923702 |
| Protocol serial number | N/A |
| Sponsor | International Agency for Research on Cancer (IARC) (France) |
| Funder | Bill and Melinda Gates Foundation (USA) - through the International Agency for Research on Cancer (IARC), World Health Organization (France) |
- Submission date
- 17/03/2008
- Registration date
- 30/06/2008
- Last edited
- 12/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rengaswamy Sankaranarayanan
Scientific
Scientific
150 Cours Albert Thomas
Lyon
69372 Cedex 08
France
| Phone | +33 (0)4 72 73 85 14 |
|---|---|
| sankar@iarc.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm multicentre cluster randomised trial (randomisation unit = villages) |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Randomised trial of two versus three doses of human papillomavirus (HPV) vaccine in India |
| Study objectives | The primary study hypothesis is that a two-dose human papillomavirus (HPV) vaccine regimen over six months would offer similar immunogenicity and protection as that of a three-dose regimen to girls against infection and cervical neoplasia caused by HPV types included in the vaccine and any oncogenic HPV types. |
| Ethics approval(s) | International Agency for Research on Cancer (IARC) Institutional Review Board, 18/02/2008 |
| Health condition(s) or problem(s) studied | Cervical precancerous lesions and cervical cancer |
| Intervention | Vaccination with the prophylactic quadrivalent vaccine of Merck (Gardasil®) which targets HPV 16, 18, 6 and 11 types for prevention of infection with the most common HPV 16 and 18 high risk types and associated cervical intraepithelial neoplasia (CIN). The participants will be randomly allocated in equal numbers to receive either two or three doses of the vaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18. Girls in the two-dose group will receive the vaccine at Day 1 and Day 180, girls in the three-dose group will receive the vaccine at Day 1, Day 60, and Day 180. |
| Intervention type | Biological/Vaccine |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) | 1. The relative type specific immunogenicity in terms of the presence of serum neutralising antibodies to HPV 16 and 18 (serum anti-HPV L1 antibody [sL1Ab]) measured using a competitive Luminex immunoassay in blood sample collected from a 15% sample of girls at 7, 12, 24, 36 and 48 months from the first dose of the vaccine 2. HPV 16/18 antibody geometric mean titres (GMTs) induced by the different dose regimes at 7, 12, 24, 36 and 48 months 3. Relative HPV 6/11 type specific immune response in the different regimens in a sample of girls 4. The relative protection in terms of frequency of incident as well as persistent (12-month definition) HPV 16 and 18 infection 5. Frequency of incident infection by other non-targeted high-risk HPV types. Initial follow-up: 5 years. Extended follow-up: 15 years. 6. HPV 16- and 18-associated CIN 2-3, adenocarcinoma in-situ and invasive cancer following the two different dose regimes. Initial follow-up: 5 years. Extended follow-up: 15 years. 7. CIN and invasive cancer associated with non-included HPV types in the two study groups. Initial follow-up: 5 years. Extended follow-up: 15 years. |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 16000 |
| Key inclusion criteria | 1. Apparently healthy, ambulant, unmarried girls aged 10 - 18 years and with intact uterus 2. Resident in the villages chosen for the study |
| Key exclusion criteria | Girls with any severe and/or debilitating illness |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 11/04/2012 |
Locations
Countries of recruitment
- India
Study participating centre
-
-
-
India
-
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No | |
| Results article | early results | 06/08/2018 | Yes | No | |
| Results article | 08/10/2021 | 12/10/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/10/2021: Publication reference added.
21/03/2018: Publication reference added.
