HPV VaccinePhase 2SHIELDNCT07377656
Strengthening HPV Immunization Through EPI Leveraged Delivery
A Phase 2 study testing HPV vaccine and Measles and rubella Vaccine in people with HPV Vaccine, run by International Vaccine Institute at 1 site in Ghana.
Trial summary
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old… Read more about this study
- Who is it for?
- Ages 9 months to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccine
- What is being tested?
- HPV vaccine and Measles and rubella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteGhana
- Study dates
- 30 Apr 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 9 months to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
- Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
- Residing within the area of the study and planning to stay for the study duration.
- Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
- Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
- Able and willing to comply with all study requirements.
- Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's/LAR's consent.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose
- Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)
- Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)
- Planning to migrate out of the study areas before the end of the study follow-up
- Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study.
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- Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
- Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment (topical steroids may be allowed).
- Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ghana1 site, 1 recruiting
- Recruiting
Dodowa Health Research Center
Accra
George Enyimah Armah, Prof., +233 208 246513, garmah@noguchi.ug.edu.gh
About this study
Official title: A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
Read the detailed description
Cervical cancer is a significant public health problem in Africa and a leading cause of cancer deaths in women. According to the WHO, Africa has the highest cervical cancer disease incidence and associated mortality in the world accounting for 19% of all global cases of cervical cancer and 23% of all cervical cancer related deaths. The high-risk Human Papillomavirus (HPV) Types16 and 18 are responsible for 70% of all global cervical cancers with a high prevalence of 22% in sub-Saharan Africa compared to a prevalence of 12%globally. The bivalent Cecolin HPV vaccine, manufactured by Innovax of China, has demonstrated >95% efficacy against HPV16/18 infections in women aged 18 to 26 years and some protection against HPV 31, 33 and 45. The hypothesis of this trial is that infants/toddlers vaccinated with the bivalent Cecolin will show similar safety, tolerability, and immunogenicity as compared to that observed in older age groups, 15 to 20year old, where efficacy has been established.
This trial is a proof-of-concept study to descriptively compare the safety, tolerability, and immunogenicity of HPV vaccination in a pediatric population. The aim is to demonstrate safety and tolerability, and that short-term immune responses in infants and toddlers are comparable to the responses in older girls and women between 15-20 years, an age group in whom efficacy has been shown. If the vaccines are shown to be safe, well tolerated, and sufficiently immunogenic in this pilot study, this would provide evidence to support larger statistically robust studies to test the safety, immunogenicity, longevity of immune response, and acceptability of including HPV vaccines in the routine EPI.
A total of one hundred and fifteen (N=115) eligible participants will be enrolled in the study with an age de-escalation approach for the pediatric cohort. First, the safety cohort of 15 children between the age of 2-5 years will be randomized in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). To progress enrolment of toddlers aged 15 months, the DSMB will review safety data of the preceding safety cohort (2-5 years old) collected in the first week (until D7 visit) of follow-up according to pre-specified halting criteria. If halting criteria are not met, a further 15 toddlers (15 months) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 toddlers, there will be a second safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 15-month-old cohort will continue recruitment. Following confirmation by the DSMB, 15 infants (9 months old) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 infants, there will be another safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 9-month-old cohort will continue recruitment. The safety cohort and the toddlers will receive either a single dose of the HPV vaccine or placebo while the 9-month-old will either receive two doses of the HPV vaccine 6 months apart or the placebo. Adolescent girls and young women aged between 15 and 20 year olds will be recruited in open label study in parallel.
- Conditions
- HPV Vaccine
- Being tested
- HPV vaccine, Placebo, Measles and rubella Vaccine
- Keywords
- HPV, Proof of concept, Ghana, SHIELD, IVI, International Vaccine Institute, Karolinska Institutet, Dodowa Health Research Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
0.5 mL HPV Vaccine Injection Intramuscular
PlaceboBiological
0.5 mL Placebo injection intramuscular
Measles and rubella VaccineBiological
Measles and rubella Vaccine according to EPI
| Study group | Role | What they receive |
|---|---|---|
| Arm AS (2-5 years old) | Experimental | HPV Vaccine Receives: Biological: HPV vaccine |
| Arm PS (2-5 years old) | Placebo comparator | Placebo Receives: Biological: Placebo |
| Arm A15 (15 months old) | Experimental | HPV Vaccine Receives: Biological: HPV vaccine; Biological: Measles and rubella Vaccine |
| Arm P15 (15 months old) | Placebo comparator | Placebo Receives: Biological: Placebo; Biological: Measles and rubella Vaccine |
| Arm A9 (9 months old) | Experimental | HPV + MR Vaccine Receives: Biological: HPV vaccine; Biological: Measles and rubella Vaccine |
| Arm P9 (9 months old) | Placebo comparator | Placebo + MR Vaccine Receives: Biological: Placebo; Biological: Measles and rubella Vaccine |
| Arm E (15-20 years old) | Active comparator | HPV Vaccine (Open Label) Receives: Biological: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Reactogenicity of HPV Vaccination
Occurrence of solicited and unsolicited adverse events following single-dose or two-dose HPV vaccination administered concomitantly with routine Expanded Programme on Immunization (EPI) vaccines, including Measles and Rubella (MR) vaccine, among infants aged 9 months, toddlers aged 15 months, and children aged 2-5 years. Results will be summarized as the number of participants experiencing adverse events
Measured: 9 months post vaccination
HPV16/18 VLP ELISA Antibody Titers
HPV16 and HPV18 antibody levels measured using Virus-Like Particle (VLP) Enzyme-Linked Immunosorbent Assay (ELISA) in serum samples collected from participants who received one or two doses of HPV vaccine. Antibody levels are expressed as ELISA antibody titers (IU/mL).
Measured: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA in vaccinated participants, expressed as IU/mL.
Measured: At 1, 7, 12, and 24 months post-HPV vaccination
Secondary outcomes (4)
HPV16/18 Seroconversion Rate
Seroconversion rate of HPV16 and HPV18 antibodies measured using VLP ELISA, defined as the proportion of participants who change from seronegative at baseline to seropositive after HPV vaccination. Results are expressed as a percentage of participants
Measured: 1 month and 7 months post HPV vaccination
HPV16/18 VLP ELISA Antibody Titers by Age and Sex
HPV16 and HPV18 antibody titers measured using VLP ELISA among male and female infants and toddlers aged 9 and 15 months and children aged 2-5 years following HPV vaccination, expressed as ELISA antibody titers (IU/mL).
Measured: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies by Age Group
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA among infants, toddlers, and children receiving HPV vaccination, expressed as IU/mL.
Measured: At 1, 7, 12, and 24 months post-HPV vaccination
Measles and Rubella Seroconversion Rate
Seroconversion rate of Measles and Rubella antibodies measured one month after MR vaccination among 9- and 15-month-old infants and toddlers who received MR vaccine with or without concomitant HPV vaccination. Results are expressed as a percentage of participants.
Measured: 1 month post MR vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Apr 2026
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study follows an age de-escalation approach for the pediatric cohort. In the observer-blind arm, children aged 2-5 years will be enrolled first. Enrollment of the subsequent age groups will proceed only after DSMB review and approval at each stage. Following the first DSMB review and approval, enrollment of a limited number of participants aged 15 months will begin. After the next DSMB review and approval, recruitment will proceed for a subset of the 9-month-old age group while continuing enrollment in the 15-month cohort. A further DSMB review and approval will determine whether enrollment of the remaining 9-month-old participants may continue. Meanwhile, the open-label cohort of participants aged 15-20 years will begin enrollment concurrently with the 2-5-year-old group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Noguchi Memorial Institute for Medical Research, Dodowa Health Research Centre
- Responsible party
- Sponsor
- Investigators
- Julia Lynch, MD, Study director, International Vaccine InstituteGeorge Armah, Prof. PhD, Principal investigator, Noguchi Memorial Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377656
- Sponsor's protocol ID
- IVI SHIELD 001
- Acronym
- SHIELD
- Status last verified
- May 2026
- First submitted
- 23 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana
- ClinicalTrials.gov ID
- NCT07377656
- Acronym / sponsor ID
- SHIELD / IVI SHIELD 001
- Conditions
- HPV Vaccine
- Keywords
- HPV, Proof of concept, Ghana, SHIELD, IVI, International Vaccine Institute, Karolinska Institutet, Dodowa Health Research Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Noguchi Memorial Institute for Medical Research, Dodowa Health Research Centre
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jan 2026 (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.
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
Detailed description
Cervical cancer is a significant public health problem in Africa and a leading cause of cancer deaths in women. According to the WHO, Africa has the highest cervical cancer disease incidence and associated mortality in the world accounting for 19% of all global cases of cervical cancer and 23% of all cervical cancer related deaths. The high-risk Human Papillomavirus (HPV) Types16 and 18 are responsible for 70% of all global cervical cancers with a high prevalence of 22% in sub-Saharan Africa compared to a prevalence of 12%globally. The bivalent Cecolin HPV vaccine, manufactured by Innovax of China, has demonstrated >95% efficacy against HPV16/18 infections in women aged 18 to 26 years and some protection against HPV 31, 33 and 45. The hypothesis of this trial is that infants/toddlers vaccinated with the bivalent Cecolin will show similar safety, tolerability, and immunogenicity as compared to that observed in older age groups, 15 to 20year old, where efficacy has been established.
This trial is a proof-of-concept study to descriptively compare the safety, tolerability, and immunogenicity of HPV vaccination in a pediatric population. The aim is to demonstrate safety and tolerability, and that short-term immune responses in infants and toddlers are comparable to the responses in older girls and women between 15-20 years, an age group in whom efficacy has been shown. If the vaccines are shown to be safe, well tolerated, and sufficiently immunogenic in this pilot study, this would provide evidence to support larger statistically robust studies to test the safety, immunogenicity, longevity of immune response, and acceptability of including HPV vaccines in the routine EPI.
A total of one hundred and fifteen (N=115) eligible participants will be enrolled in the study with an age de-escalation approach for the pediatric cohort. First, the safety cohort of 15 children between the age of 2-5 years will be randomized in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). To progress enrolment of toddlers aged 15 months, the DSMB will review safety data of the preceding safety cohort (2-5 years old) collected in the first week (until D7 visit) of follow-up according to pre-specified halting criteria. If halting criteria are not met, a further 15 toddlers (15 months) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 toddlers, there will be a second safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 15-month-old cohort will continue recruitment. Following confirmation by the DSMB, 15 infants (9 months old) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 infants, there will be another safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 9-month-old cohort will continue recruitment. The safety cohort and the toddlers will receive either a single dose of the HPV vaccine or placebo while the 9-month-old will either receive two doses of the HPV vaccine 6 months apart or the placebo. Adolescent girls and young women aged between 15 and 20 year olds will be recruited in open label study in parallel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- This study follows an age de-escalation approach for the pediatric cohort. In the observer-blind arm, children aged 2-5 years will be enrolled first. Enrollment of the subsequent age groups will proceed only after DSMB review and approval at each stage. Following the first DSMB review and approval, enrollment of a limited number of participants aged 15 months will begin. After the next DSMB review and approval, recruitment will proceed for a subset of the 9-month-old age group while continuing enrollment in the 15-month cohort. A further DSMB review and approval will determine whether enrollment of the remaining 9-month-old participants may continue. Meanwhile, the open-label cohort of participants aged 15-20 years will begin enrollment concurrently with the 2-5-year-old group.
| Arm | Type | Receives |
|---|---|---|
| Arm AS (2-5 years old) | Experimental | Biological: HPV vaccineHPV Vaccine |
| Arm PS (2-5 years old) | Placebo comparator | Biological: PlaceboPlacebo |
| Arm A15 (15 months old) | Experimental | Biological: HPV vaccine, Biological: Measles and rubella VaccineHPV Vaccine |
| Arm P15 (15 months old) | Placebo comparator | Biological: Placebo, Biological: Measles and rubella VaccinePlacebo |
| Arm A9 (9 months old) | Experimental | Biological: HPV vaccine, Biological: Measles and rubella VaccineHPV + MR Vaccine |
| Arm P9 (9 months old) | Placebo comparator | Biological: Placebo, Biological: Measles and rubella VaccinePlacebo + MR Vaccine |
| Arm E (15-20 years old) | Active comparator | Biological: HPV vaccineHPV Vaccine (Open Label) |
Who may qualify
- Ages
- 9 months to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
- Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
- Residing within the area of the study and planning to stay for the study duration.
- Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
- Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
Key exclusion criteria (10 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose
- Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)
- Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)
- Planning to migrate out of the study areas before the end of the study follow-up
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 |
|---|---|---|
| HPV vaccine0.5 mL HPV Vaccine Injection Intramuscular | Biological | Arm A15 (15 months old), Arm A9 (9 months old), Arm AS (2-5 years old), Arm E (15-20 years old) |
| Placebo0.5 mL Placebo injection intramuscular | Biological | Arm P15 (15 months old), Arm P9 (9 months old), Arm PS (2-5 years old) |
| Measles and rubella VaccineMeasles and rubella Vaccine according to EPI | Biological | Arm A15 (15 months old), Arm A9 (9 months old), Arm P15 (15 months old), Arm P9 (9 months old) |
Primary outcome
Safety and Reactogenicity of HPV Vaccination
Time frame: 9 months post vaccination
Occurrence of solicited and unsolicited adverse events following single-dose or two-dose HPV vaccination administered concomitantly with routine Expanded Programme on Immunization (EPI) vaccines, including Measles and Rubella (MR) vaccine, among infants aged 9 months, toddlers aged 15 months, and children aged 2-5 years. Results will be summarized as the number of participants experiencing adverse events
HPV16/18 VLP ELISA Antibody Titers
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
HPV16 and HPV18 antibody levels measured using Virus-Like Particle (VLP) Enzyme-Linked Immunosorbent Assay (ELISA) in serum samples collected from participants who received one or two doses of HPV vaccine. Antibody levels are expressed as ELISA antibody titers (IU/mL).
Geometric Mean Concentration of HPV16/18 Antibodies
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA in vaccinated participants, expressed as IU/mL.
4 secondary outcomes
HPV16/18 Seroconversion Rate
Time frame: 1 month and 7 months post HPV vaccination
HPV16/18 VLP ELISA Antibody Titers by Age and Sex
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies by Age Group
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Measles and Rubella Seroconversion Rate
Time frame: 1 month post MR vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Julia Lynch, MD study director
International Vaccine Institute
George Armah, Prof. PhD principal investigator
Noguchi Memorial Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPV vaccine and Measles and rubella Vaccine in people with HPV Vaccine, run by International Vaccine Institute at 1 site in Ghana.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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 Ghana. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derick Kimathi, MBChB, PhD (+254 727161778, Derick.Kimathi@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Reactogenicity of HPV Vaccination (time frame: 9 months post vaccination). 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?
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 18 May 2026.