Human Papillomavirus VaccinePhase 3HPVNCT03832049
HPV Vaccination in Africa- New Delivery Schedules Alias The HANDS HPV Vaccine Trial
A Phase 3 study testing 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses, 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses and 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose in people with Human Papillomavirus Vaccine, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa. Read more about this study
- Who is it for?
- Ages 4 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccine
- What is being tested?
- 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses, 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses and 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,720 participants
- Where
- 1 siteThe Gambia
- Study dates
- 14 Sep 2019to Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 4 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Signed/thumb-printed informed consent obtained from the participant's parent (4 to 17 year-olds) or signed/thumb-printed informed consent obtained from the participant (18 years and above)
- Signed/thumb-printed assent obtained from the participant (12 to 17 year-olds only).
- Documented verbal assent obtained from the participant (6 to 11 year-olds only)
- Participant is of female sex (based on participant/parent self-report)
- Participant is between 4 and 26 years of age inclusive
- Parent/participant is willing and judged able to comply with the necessary study procedures
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- Parent/participant does not have established plans to leave the study area for a prolonged period/indefinitely during the 3 year follow-up period
- Participant is resident within the study area (no fixed boundaries will be set and decisions will be made on a case-by-case basis by the study team taking into account not only distance but also transport links, accessibility for the purposes of safety data collection, willingness of the parent/participant to travel)
- Place of residence of the participant must be readily identifiable
Who cannot join
- Receipt of other investigational medicinal products (IMP) in a period of 12 months prior to the day of randomization and vaccination or plans to receive IMP during the trial.
- Presence of significant chronic health problems requiring long-term medication or medical follow-up including respiratory, cardiac, gastrointestinal, hepatic, renal, neurological, musculoskeletal, haematological or other conditions based on parental history and physical examination of the participant. Participants with known sickle cell disease (but not sickle cell trait) will be excluded.
- History of severe allergic reactions to any prior vaccine or to any component of the study vaccine (including alum (amorphous aluminum hydroxyphosphate sulphate), yeast or Benzonase). Severe allergic reactions are defined as reactions requiring urgent medical intervention including reactions with any degree of cardiorespiratory compromise. The occurrence of a mild rash without other associated symptoms or signs does not generally represent an exclusion. Allergic reactions should be distinguished from the local and systemic reactogenicity expected in the first few days following vaccination which is not an exclusion to vaccination
- Prior receipt of an HPV vaccine
- Receipt of any vaccine in the 28 days prior to randomization and vaccination‡
- History of thrombocytopenia or coagulation disorders which represent contraindications in intramuscular (IM) vaccination
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- Known congenital or acquired immune deficiency or history strongly indicative of abnormal immune function. HIV testing will not be undertaken as part of the routine screening procedures due to the relatively low prevalence of HIV expected in the population (~1-3%) and the established safety and immunogenicity profile of Gardasil in HIV positive individuals.
- Receipt of medications or other treatments known to suppress the immune system in a period of 12 months prior to the day of randomization or plans to receive such medications and treatments during the course of the trial. Such medications and treatments include but not limited to high dose non-replacement) oral or parenteral steroids for more than 14 days, chemotherapeutic agents, methotrexate, cyclophosphamide, cyclosporin, Tacrolimus, any monoclonal antibody therapy and radiotherapy. The use of topical and inhaled steroids are not exclusion criteria.
- Receipt of intravenous immunoglobulins or blood products within a period of 12 months prior to the day of randomization and vaccination or plans to receive such products during the course of the trial.
- Pregnancy (females in the 15 to 26 years old cohort will require a urine pregnancy test as part of the screening procedures and will also have a urine pregnancy test undertaken prior to the second and third vaccination and vaccination delayed if pregnancy is confirmed. A minimum of 42 days from the end of pregnancy (irrespective of outcome) will be left before the delayed vaccination is administered. Participants who are pregnant at initial screening will not be re-screened but will be defined as screen failures. Breast feeding is not an exclusion criterion
- Intention to become pregnant within six months of enrollment in the trial. Confirmation regarding the use of a reliable method of contraception is not required but females who are actively seeking to become pregnant within six months of enrollment will be excluded.
- Fever (>38.0°C) on the day of vaccination or documented fever (>38.0°C) within the 24 hours preceding vaccination
- Abnormal (Grade > 1) vital signs (heart rate, respiratory rate, blood pressure) on the day of vaccination
- Positive rapid diagnostic test (RDT) or blood film for malaria on the day of vaccination
- Clinically-significant (Grade > 2) acute illness present on the day of vaccination (minor illnesses including upper respiratory tract infections, diarrhoeal illness and skin complaints not associated with fever or significant systemic upset are not in themselves reasons for exclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Observer-blind, Non-inferiority Trial to Evaluate Alternative Human Papillomavirus (HPV) Vaccination Schedules in Females in West Africa
A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa.
Read the detailed description
This study is a randomized, open-label, single-centre, phase 3 non-inferiority clinical trial of the Gardasil 9 vaccine. It will be undertaken in three female cohorts (15 to 26 years old; 9 to 14 years-olds and 4 to 8 year-olds). In total 1720 female participants will be recruited in a rural setting in The Gambia, West Africa.
The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18,31,33,45,52 and 58 VLP. It is licensed by both European Medicines Agency and the US Food and Drug Administration as a two or three dose schedule to 9 to 14 year olds and as a three dose schedule to 15 to 26 years olds. The license covers both males and females. The vaccine is not currently licensed for those under 9 years of age and it is not licenced in The Gambia.
All females within the 15 to 26 year-old cohort will receive three doses of Gardasil 9 at 0, 2 and 6 months and represent the reference group for the purposes of the serological non-inferiority analysis. This is the only group for which efficacy data for the vaccine are available. Females in the 9 to 14 year old and 4 to 8 year old cohorts will be randomized to receive either one or two doses of Gardasil 9. In both groups, the two doses will be administered at 0 and 6 months.
The primary and secondary immunogenicity objectives will be analysed based on serological Samples taken 4 to 6 weeks after the last dose of vaccine received according to group. Additional analysis will be undertaken at 12, 24 and 36 months. The Sampling schedule is aligned with the schedule in other immunogenicity trials to facilitate comparison and potential immunobridging to future one-dose efficacy data. In addition, the stability of the antibody concentrations between 12 and 24 and again between 24 and 36 months according to schedule and age-group aims to allow longer term predictions regarding the maintenance of antibody concentration to be made.
A Sub-study will be undertaken within the main trial to compare in detail early immunological events taking place following Gardasil 9. The quantitative and qualitative changes in these events following a first and following subsequent doses of the vaccine and also according to age will be assessed and related to the early and long-term antibody concentrations induced by the vaccine. There are currently no data exploring the basis for the progressive increase in the immunogenicity of the HPV vaccines apparent with decreasing age. These may have their origins in the early innate response following vaccination-which will be assessed at a cellular as well as transcriptomic level, as well as in the subsequent adaptive profile.
Similarly, the cellular basis for the sustained seropositivity induced by the HPV vaccines even apparent following a single vaccine dose is little understood. The window onto which plasmablasts and memory B-cell populations in the circulation is transient following vaccination. However, enumerating and characterizing these populations and relating them in the same way to early and long term antibody concentration aims to provide insight into the relative roles of these populations and how they are influenced by the age of the vaccine and the number of vaccine doses received.
Individuals in the sub-study will contribute serological data to the main trial and will be followed up in the same way but will be consented for one additional blood sample after each vaccination. Up to 120 participant in each group in the main trial will be randomized to groups A, B or C, with 40 participants in each of these groups. This number aims to generate a dataset of at least 30 analyzable individuals per schedule and age group.
- Conditions
- Human Papillomavirus Vaccine
- Being tested
- 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses, 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses, 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose
- Keywords
- HPV vaccination in healthy females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent human papillomavirus vaccine (Gardasil 9) - 3 dosesBiological
0.5mL intramuscular dose - 3 doses (0, 2 and 6 months)
9-valent human papillomavirus vaccine (Gardasil 9) - 2 dosesBiological
0.5mL intramuscular dose - 2 doses (0 and 6 months)
9-valent human papillomavirus vaccine (Gardasil 9) - 1 doseBiological
0.5mL intramuscular dose - 1 doses (0 months)
| Study group | Role | What they receive |
|---|---|---|
| 15 to 26 years - 3 dose | Active comparator | 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses Receives: Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses |
| 9 to 14 years - 2 dose | Experimental | 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses Receives: Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses |
| 4 to 8 years - 2 dose | Experimental | 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses Receives: Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses |
| 9 to 14 years - 1 dose | Experimental | 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose Receives: Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose |
| 4 to 8 years - 1 dose | Experimental | 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose Receives: Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies measured by 9-valent HPV competitive Luminex immunoassay (cLIA) (mMU/mL)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 4 weeks after last vaccine dose
Acute allergic reaction (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Day of vaccination (day 0)
Injection site pain (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Injection site redness (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Injection site swelling (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Injection site pruritus (Grade 0 - 4)
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Temperature in degrees Centigrade
Recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Nausea/vomiting (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Headaches (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Dizziness (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Fatigue (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Myalgia/arthralgia (Grade 0 - 4)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Measured: Days 0 to 6 after vaccination
Unsolicited adverse event (AE) including serious adverse events
Unsolicited AE will be recorded in 4 to 8 years olds and 9 to 14 year olds
Measured: Day 0 to day 28 following each vaccination
Suspected unexpected serious adverse reactions (SUSAR)
SUSAR will be collected from all participants
Measured: Day 0 to month 36
Secondary outcomes (7)
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 12 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 24 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 36 months after first vaccination
Antibodies measure by 9-valent HPV total IgG (TIgG)
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 4 weeks after last vaccine dose
Antibodies measure by 9-valent HPV TIgG
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 12 months after first vaccination
Antibodies measure by 9-valent HPV TIgG
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 24 months after first vaccination
Antibodies measure by 9-valent HPV TIgG
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Measured: 36 months after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start14 Sep 2019
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccineStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, open-label, single-centre, phase 3, noninferiority clinical trial of the Gardasil 9 vaccine
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England, University of Cambridge, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ed Clarke, MB ChB PhD, Principal investigator, Medical Research Council @ LSHTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832049
- Sponsor's protocol ID
- SCC 1597
- Acronym
- HPV
- Status last verified
- Mar 2022
- First submitted
- 18 Jan 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-blind, Non-inferiority Trial to Evaluate Alternative Human Papillomavirus (HPV) Vaccination Schedules in Females in West Africa
- ClinicalTrials.gov ID
- NCT03832049
- Acronym / sponsor ID
- HPV / SCC 1597
- Conditions
- Human Papillomavirus Vaccine
- Keywords
- HPV vaccination in healthy females
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,720 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Public Health England, University of Cambridge, Merck Sharp & Dohme LLC
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, observer-blind non-inferiority trial to evaluate alternative human papillomavirus (HPV) vaccination schedules in young females in West Africa.
Detailed description
This study is a randomized, open-label, single-centre, phase 3 non-inferiority clinical trial of the Gardasil 9 vaccine. It will be undertaken in three female cohorts (15 to 26 years old; 9 to 14 years-olds and 4 to 8 year-olds). In total 1720 female participants will be recruited in a rural setting in The Gambia, West Africa.
The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18,31,33,45,52 and 58 VLP. It is licensed by both European Medicines Agency and the US Food and Drug Administration as a two or three dose schedule to 9 to 14 year olds and as a three dose schedule to 15 to 26 years olds. The license covers both males and females. The vaccine is not currently licensed for those under 9 years of age and it is not licenced in The Gambia.
All females within the 15 to 26 year-old cohort will receive three doses of Gardasil 9 at 0, 2 and 6 months and represent the reference group for the purposes of the serological non-inferiority analysis. This is the only group for which efficacy data for the vaccine are available. Females in the 9 to 14 year old and 4 to 8 year old cohorts will be randomized to receive either one or two doses of Gardasil 9. In both groups, the two doses will be administered at 0 and 6 months.
The primary and secondary immunogenicity objectives will be analysed based on serological Samples taken 4 to 6 weeks after the last dose of vaccine received according to group. Additional analysis will be undertaken at 12, 24 and 36 months. The Sampling schedule is aligned with the schedule in other immunogenicity trials to facilitate comparison and potential immunobridging to future one-dose efficacy data. In addition, the stability of the antibody concentrations between 12 and 24 and again between 24 and 36 months according to schedule and age-group aims to allow longer term predictions regarding the maintenance of antibody concentration to be made.
A Sub-study will be undertaken within the main trial to compare in detail early immunological events taking place following Gardasil 9. The quantitative and qualitative changes in these events following a first and following subsequent doses of the vaccine and also according to age will be assessed and related to the early and long-term antibody concentrations induced by the vaccine. There are currently no data exploring the basis for the progressive increase in the immunogenicity of the HPV vaccines apparent with decreasing age. These may have their origins in the early innate response following vaccination-which will be assessed at a cellular as well as transcriptomic level, as well as in the subsequent adaptive profile.
Similarly, the cellular basis for the sustained seropositivity induced by the HPV vaccines even apparent following a single vaccine dose is little understood. The window onto which plasmablasts and memory B-cell populations in the circulation is transient following vaccination. However, enumerating and characterizing these populations and relating them in the same way to early and long term antibody concentration aims to provide insight into the relative roles of these populations and how they are influenced by the age of the vaccine and the number of vaccine doses received.
Individuals in the sub-study will contribute serological data to the main trial and will be followed up in the same way but will be consented for one additional blood sample after each vaccination. Up to 120 participant in each group in the main trial will be randomized to groups A, B or C, with 40 participants in each of these groups. This number aims to generate a dataset of at least 30 analyzable individuals per schedule and age group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- a randomized, open-label, single-centre, phase 3, noninferiority clinical trial of the Gardasil 9 vaccine
| Arm | Type | Receives |
|---|---|---|
| 15 to 26 years - 3 dose | Active comparator | Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses |
| 9 to 14 years - 2 dose | Experimental | Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses |
| 4 to 8 years - 2 dose | Experimental | Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses |
| 9 to 14 years - 1 dose | Experimental | Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose |
| 4 to 8 years - 1 dose | Experimental | Biological: 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose |
Who may qualify
- Ages
- 4 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Signed/thumb-printed informed consent obtained from the participant's parent (4 to 17 year-olds) or signed/thumb-printed informed consent obtained from the participant (18 years and above)
- Signed/thumb-printed assent obtained from the participant (12 to 17 year-olds only).
- Documented verbal assent obtained from the participant (6 to 11 year-olds only)
- Participant is of female sex (based on participant/parent self-report)
- Participant is between 4 and 26 years of age inclusive
Key exclusion criteria (15 listed)
- Receipt of other investigational medicinal products (IMP) in a period of 12 months prior to the day of randomization and vaccination or plans to receive IMP during the trial.
- Presence of significant chronic health problems requiring long-term medication or medical follow-up including respiratory, cardiac, gastrointestinal, hepatic, renal, neurological, musculoskeletal, haematological or other conditions based on parental history and physical examination of the participant. Participants with known sickle cell disease (but not sickle cell trait) will be excluded.
- History of severe allergic reactions to any prior vaccine or to any component of the study vaccine (including alum (amorphous aluminum hydroxyphosphate sulphate), yeast or Benzonase). Severe allergic reactions are defined as reactions requiring urgent medical intervention including reactions with any degree of cardiorespiratory compromise. The occurrence of a mild rash without other associated symptoms or signs does not generally represent an exclusion. Allergic reactions should be distinguished from the local and systemic reactogenicity expected in the first few days following vaccination which is not an exclusion to vaccination
- Prior receipt of an HPV vaccine
- Receipt of any vaccine in the 28 days prior to randomization and vaccination‡
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 |
|---|---|---|
| 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses0.5mL intramuscular dose - 3 doses (0, 2 and 6 months) | Biological | 15 to 26 years - 3 dose |
| 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses0.5mL intramuscular dose - 2 doses (0 and 6 months) | Biological | 4 to 8 years - 2 dose, 9 to 14 years - 2 dose |
| 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose0.5mL intramuscular dose - 1 doses (0 months) | Biological | 4 to 8 years - 1 dose, 9 to 14 years - 1 dose |
Primary outcome
Antibodies measured by 9-valent HPV competitive Luminex immunoassay (cLIA) (mMU/mL)
Time frame: 4 weeks after last vaccine dose
HPV types, 6, 11, 16, 18, 31, 33, 45, 52 and 58
Acute allergic reaction (Grade 0 - 4)
Time frame: Day of vaccination (day 0)
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Injection site pain (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Injection site redness (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Injection site swelling (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Injection site pruritus (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited local reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Temperature in degrees Centigrade
Time frame: Days 0 to 6 after vaccination
Recorded in 4 to 8 year olds and 9 to 14 year olds
Nausea/vomiting (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Headaches (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Dizziness (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Fatigue (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Myalgia/arthralgia (Grade 0 - 4)
Time frame: Days 0 to 6 after vaccination
Solicited systemic reactogenicity recorded in 4 to 8 year olds and 9 to 14 year olds
Unsolicited adverse event (AE) including serious adverse events
Time frame: Day 0 to day 28 following each vaccination
Unsolicited AE will be recorded in 4 to 8 years olds and 9 to 14 year olds
Suspected unexpected serious adverse reactions (SUSAR)
Time frame: Day 0 to month 36
SUSAR will be collected from all participants
7 secondary outcomes
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
Time frame: 12 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
Time frame: 24 months after first vaccination
Antibodies measured by 9-valent HPV cLIA (mMU/mL)
Time frame: 36 months after first vaccination
Antibodies measure by 9-valent HPV total IgG (TIgG)
Time frame: 4 weeks after last vaccine dose
Antibodies measure by 9-valent HPV TIgG
Time frame: 12 months after first vaccination
Antibodies measure by 9-valent HPV TIgG
Time frame: 24 months after first vaccination
Antibodies measure by 9-valent HPV TIgG
Time frame: 36 months after first vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Ed Clarke, MB ChB PhD principal investigator
Medical Research Council @ LSHTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses, 9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses and 9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose in people with Human Papillomavirus Vaccine, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 9 inclusion and 15 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Antibodies measured by 9-valent HPV competitive Luminex immunoassay (cLIA) (mMU/mL) (time frame: 4 weeks after last vaccine dose). The study lists 14 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 NCT03832049, which also lists 1 linked publication.
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 31 Mar 2022.