Cervical CancersPhase 3NCT00943722

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

A Phase 3 study testing V503 in people with Cervical Cancers and Vulvar Cancer, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different… Read more about this study

Who is it for?: Ages 9 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Cervical Cancers, Vulvar Cancer, Vaginal Cancer
What is being tested?: V503
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,074 participants
Where: No sites listed yet
Study dates: 27 Aug 2009to 22 Apr 2021
Phase: Phase 3
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 9 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Boys and Girls Age 9 to 15:
Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
Women Age 16 to 26:
Participant has never had Pap testing or has had only normal results
Participant has had 0 to 4 sexual partners at the time of enrollment

Who cannot join

Boys and Girls Age 9 to 15:
History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial

Show all 16Show fewer

Participant has a history of positive test for HPV
Women Age 16 to 26:
History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Participant has a history of positive test for HPV
Participant has a history of abnormal cervical biopsy result
Participant has a history of external genital lesions

About this study

Official title: A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

The primary hypotheses are as follows:

The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

Read the detailed description

The base study V503-002 was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.

An optional extension study (V503-002 EXT1) collected safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT1. Per protocol, EXT1 included immunogenicity data from a subset of 9- to 15-year-old females and safety data from all 9- to 15-year-old females regardless of lot administered.

An optional second extension study (V503-002 EXT2) collected long-term safety and immunogenicity information through approximately Month 126. No study vaccine was administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT2. Per protocol, EXT2 included immunogenicity data from a subset of 9- to 15-year-old females and effectiveness and safety data from all 9- to 15-year-old females regardless of lot administered.

Conditions: Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions, PAP Test Abnormalities, HPV Infections
Being tested: V503
Medical subject headings: Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Papillomavirus Infections

What participants receive

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

V503Biological
Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.

Study groups in NCT00943722
Study group	Role	What they receive
9- to 15-Year-Old Females (Lot 1)	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. Receives: Biological: V503
9- to 15-Year-Old Females (Lot 2)	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2. Receives: Biological: V503
9- to 15-Year-Old Females (Lot 3)	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3. Receives: Biological: V503
9- to 15-Year-Old Males (Lot 1)	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. Receives: Biological: V503
16- to 26-Year-Old Females (Lot 1)	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1. Receives: Biological: V503

What is being measured

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

Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Measured: 4 weeks post-vaccination 3 (Month 7)
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Measured: 4 weeks post-vaccination 3 (Month 7)
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
Measured: 4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Measured: Up to 5 days after any vaccination
Base Study: Percentage of Participants With Systemic AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. Systemic AEs were those not categorized as injection-site AEs.
Measured: Up to 15 days after any vaccination
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
Measured: Up to 5 days after any vaccination
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Measured: Up to ~Month 126
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Measured: Up to ~Month 126

Secondary outcomes (8)

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Measured: 4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Measured: 4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Measured: 4 weeks post-vaccination 3 (Month 7)
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females
Persistent infection is when a participant is positive by polymerase chain reaction (PCR) for the same HPV type in cervicovaginal/external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later. Per protocol, the extension study included 9- to 15-year-old females regardless of lot administered.
Measured: Up to ~Month 126
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males
Persistent infection is when a participant is positive by PCR for the same HPV type in external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later.
Measured: Up to ~Month 126
Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females
The combined incidence of cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, and cervical/vulvar/vaginal cancers, related to HPV 6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Measured: Up to ~Month 126
Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males
The combined incidence of penile intraepithelial neoplasia, penile/perineal/perianal cancers, and genital warts related to HPV6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. For each study participant, person-years follow up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later.
Measured: Up to ~Month 126
Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events
A serious adverse event (SAE) included a death which resulted in the participant discontinuing the study, a serious adverse experience that was considered by an investigator who was a qualified physician to be possibly, probably, or definitely vaccine related or study procedure related. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Measured: Up to ~Month 126

Timeline

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

27 Aug 200922 Apr 2021

First posted22 Jul 2009 (estimated)
Study start27 Aug 2009
Primary completion30 Apr 2011
Study completion22 Apr 2021

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 CancersStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 3,074 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00943722
Sponsor's protocol ID: V503-002
Other IDs: 2009_611, 2009-011617-25, 2009
Status last verified: Sep 2022
First submitted: 21 Jul 2009
Last updated: 3 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Luxembourg A, Moreira ED Jr, Samakoses R, Kim KH, Sun X, Maansson R, Moeller E, Christiano S, Chen J. Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine. Hum Vaccin Immunother. 2015;11(6):1306-12. doi: 10.1080/21645515.2015.1009819.
PubMed 26086587
Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang LM, Kim DS, Pitisuttithum P, Chen J, Christiano S, Maansson R, Moeller E, Sun X, Vuocolo S, Luxembourg A. Immunogenicity and Safety of a 9-Valent HPV Vaccine. Pediatrics. 2015 Jul;136(1):e28-39. doi: 10.1542/peds.2014-3745.
PubMed 26101366
Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
PubMed 27422279
Olsson SE, Restrepo JA, Reina JC, Pitisuttithum P, Ulied A, Varman M, Van Damme P, Moreira ED Jr, Ferris D, Block S, Bautista O, Gallagher N, McCauley J, Luxembourg A. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Res. 2020 Dec;10:100203. doi: 10.1016/j.pvr.2020.100203. Epub 2020 Jul 11.
PubMed 32659510
Restrepo J, Herrera T, Samakoses R, Reina JC, Pitisuttithum P, Ulied A, Bekker LG, Moreira ED, Olsson SE, Block SL, Hammes LS, Laginha F, Ferenczy A, Kurman R, Ronnett BM, Stoler M, Bautista O, Gallagher NE, Salituro G, Ye M, Luxembourg A. Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety. Pediatrics. 2023 Oct 1;152(4):e2022060993. doi: 10.1542/peds.2022-060993.
PubMed 37667847
Garland SM, Pitisuttithum P, Ngan HYS, Cho CH, Lee CY, Chen CA, Yang YC, Chu TY, Twu NF, Samakoses R, Takeuchi Y, Cheung TH, Kim SC, Huang LM, Kim BG, Kim YT, Kim KH, Song YS, Lalwani S, Kang JH, Sakamoto M, Ryu HS, Bhatla N, Yoshikawa H, Ellison MC, Han SR, Moeller E, Murata S, Ritter M, Sawata M, Shields C, Walia A, Perez G, Luxembourg A. Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries. J Infect Dis. 2018 Jun 5;218(1):95-108. doi: 10.1093/infdis/jiy133.
PubMed 29767739
Ruiz-Sternberg AM, Moreira ED Jr, Restrepo JA, Lazcano-Ponce E, Cabello R, Silva A, Andrade R, Revollo F, Uscanga S, Victoria A, Guevara AM, Luna J, Plata M, Dominguez CN, Fedrizzi E, Suarez E, Reina JC, Ellison MC, Moeller E, Ritter M, Shields C, Cashat M, Perez G, Luxembourg A. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Res. 2018 Jun;5:63-74. doi: 10.1016/j.pvr.2017.12.004. Epub 2017 Dec 19.
PubMed 29269325

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?

Official record

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RecruitingPhase 4
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All Cervical Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
ClinicalTrials.gov ID: NCT00943722
Acronym / sponsor ID: V503-002
Conditions: Cervical Cancers, Vulvar Cancer, Vaginal Cancer, Genital Lesions, PAP Test Abnormalities, HPV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,074 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Aug 2009 (actual)
Primary completion: 30 Apr 2011 (actual)
Study completion: 22 Apr 2021 (actual)
First posted: 22 Jul 2009 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

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

The primary hypotheses are as follows:

The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

Detailed description

The base study V503-002 was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.

Study design

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

Arm	Type	Receives
9- to 15-Year-Old Females (Lot 1)	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
9- to 15-Year-Old Females (Lot 2)	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
9- to 15-Year-Old Females (Lot 3)	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
9- to 15-Year-Old Males (Lot 1)	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
16- to 26-Year-Old Females (Lot 1)	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.

Who may qualify

Ages: 9 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
Participant has never had Pap testing or has had only normal results
Participant has had 0 to 4 sexual partners at the time of enrollment

Key exclusion criteria (16 listed)

History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial

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
V503Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.	Biological	16- to 26-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 1), 9- to 15-Year-Old Females (Lot 2), 9- to 15-Year-Old Females (Lot 3), 9- to 15-Year-Old Males (Lot 1)

Primary outcome

Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Time frame: 4 weeks post-vaccination 3 (Month 7)
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Time frame: 4 weeks post-vaccination 3 (Month 7)
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Time frame: 4 weeks post-vaccination 3 (Month 7)
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
Time frame: Up to 5 days after any vaccination
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Base Study: Percentage of Participants With Systemic AEs
Time frame: Up to 15 days after any vaccination
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. Systemic AEs were those not categorized as injection-site AEs.
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
Time frame: Up to 5 days after any vaccination
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Time frame: Up to ~Month 126
Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Time frame: Up to ~Month 126
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.

8 secondary outcomes

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Time frame: 4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Time frame: 4 weeks post-vaccination 3 (Month 7)
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Time frame: 4 weeks post-vaccination 3 (Month 7)
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females
Time frame: Up to ~Month 126
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males
Time frame: Up to ~Month 126
Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females
Time frame: Up to ~Month 126
Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males
Time frame: Up to ~Month 126
Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events
Time frame: Up to ~Month 126

Results and safety

Results posted to the registry on 13 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Base Study: 9- to 15-Year-Old Females (Lot 1)	648	623
Base Study: 9- to 15-Year-Old Females (Lot 2)	643	621
Base Study: 9- to 15-Year-Old Females (Lot 3)	644	631
Base Study: 9- to 15-Year-Old Males (Lot 1)	669	647
Base Study: 16- to 26-Year-Old Females (Lot 1)	470	444
Extension Study: 9- to 15-Year-Old Females	0	0
Extension Study: 9- to 15-Year-Old Males	0	0

Primary outcome: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])

Time frame: 4 weeks post-vaccination 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: milli Merck Units/mL

Measure	Base Study: 9- to 15-Year-Old Females (Lot 1) n = 535	Base Study: 9- to 15-Year-Old Males (Lot 1) n = 378
Anti-HPV 6	1715.4 (1595.1 to 1844.7)	900.8 (822.3 to 986.9)
Anti-HPV 11	1295.1 (1204.1 to 1393.0)	706.6 (645.2 to 773.8)
Anti-HPV 16	6979.8 (6508.1 to 7485.8)	3522.6 (3223.5 to 3849.5)
Anti-HPV 18	2153.7 (1980.4 to 2342.1)	882.7 (795.4 to 979.5)
Anti-HPV 31	1891.6 (1745.7 to 2049.7)	753.9 (682.5 to 832.7)
Anti-HPV 33	980.4 (911.7 to 1054.3)	466.8 (426.9 to 510.3)
Anti-HPV 45	714.4 (651.9 to 782.8)	272.2 (243.8 to 303.9)
Anti-HPV 52	932.9 (864.8 to 1006.4)	419.6 (381.4 to 461.5)

Base Study: 9- to 15-Year-Old Females (Lot 1) vs Base Study: 9- to 15-Year-Old Males (Lot 1): GMT ratio: 1.90 (95% CI 1.70 to 2.14), p < 0.001, ANOVA
Base Study: 9- to 15-Year-Old Females (Lot 1) vs Base Study: 9- to 15-Year-Old Males (Lot 1): GMT ratio: 1.83 (95% CI 1.63 to 2.06), p < 0.001, ANOVA
Base Study: 9- to 15-Year-Old Females (Lot 1) vs Base Study: 9- to 15-Year-Old Males (Lot 1): GMT ratio: 1.98 (95% CI 1.77 to 2.22), p < 0.001, ANOVA

Population analysed: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.

Primary outcome: Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])

Time frame: 4 weeks post-vaccination 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: milli Merck Units/mL

Measure	Base Study: 9- to 15-Year-Old Males (Lot 1) n = 570	Base Study: 16- to 26-Year-Old Females (Lot 1) n = 378
Anti-HPV 6	2084.7 (1944.0 to 2235.7)	900.8 (822.3 to 986.9)
Anti-HPV 11	1487.1 (1386.5 to 1595.0)	706.6 (645.2 to 773.8)
Anti-HPV 16	8628.9 (8065.9 to 9231.3)	3522.6 (3223.5 to 3849.5)
Anti-HPV 18	2822.8 (2602.8 to 3061.5)	882.7 (795.4 to 979.5)
Anti-HPV 31	2221.2 (2056.1 to 2399.5)	753.9 (682.5 to 832.7)
Anti-HPV 33	1198.7 (1117.1 to 1286.2)	466.8 (426.9 to 510.3)
Anti-HPV 45	907.0 (830.2 to 991.0)	272.2 (243.8 to 303.9)
Anti-HPV 52	1037.8 (964.4 to 1116.9)	419.6 (381.4 to 461.5)

Base Study: 9- to 15-Year-Old Males (Lot 1) vs Base Study: 16- to 26-Year-Old Females (Lot 1): GMT ratio: 2.31 (95% CI 2.07 to 2.59), p < 0.001, ANOVA
Base Study: 9- to 15-Year-Old Males (Lot 1) vs Base Study: 16- to 26-Year-Old Females (Lot 1): GMT ratio: 2.10 (95% CI 1.88 to 2.36), p < 0.001, ANOVA
Base Study: 9- to 15-Year-Old Males (Lot 1) vs Base Study: 16- to 26-Year-Old Females (Lot 1): GMT ratio: 2.45 (95% CI 2.19 to 2.74), p < 0.001, ANOVA

Population analysed: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.

Primary outcome: Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)

Time frame: 4 weeks post-vaccination 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: milli Merck Units/mL

Measure	Base Study: 9- to 15-Year-Old Females (Lot 1) n = 535	Base Study: 9- to 15-Year-Old Females (Lot 2) n = 549	Base Study: 9- to 15-Year-Old Females (Lot 3) n = 565
Anti-HPV 6	1715.4 (1588.7 to 1852.2)	1763.3 (1635.4 to 1901.3)	1659.9 (1540.3 to 1788.7)
Anti-HPV 11	1295.1 (1197.8 to 1400.3)	1311.7 (1214.9 to 1416.3)	1232.0 (1141.7 to 1329.5)
Anti-HPV 16	6979.8 (6476.1 to 7522.8)	7292.9 (6772.7 to 7853.1)	6948.2 (6458.7 to 7474.9)
Anti-HPV 18	2153.7 (1970.9 to 2353.5)	2134.1 (1955.6 to 2329.0)	1966.6 (1804.3 to 2143.5)
Anti-HPV 31	1891.6 (1738.5 to 2058.2)	1867.8 (1719.3 to 2029.1)	1879.0 (1731.0 to 2039.6)
Anti-HPV 33	980.4 (909.2 to 1057.2)	922.7 (856.2 to 994.4)	931.1 (865.0 to 1002.3)
Anti-HPV 45	714.4 (650.1 to 785.0)	827.7 (754.1 to 908.5)	678.4 (619.0 to 743.6)
Anti-HPV 52	932.9 (860.8 to 1011.0)	1007.9 (931.0 to 1091.2)	971.2 (898.1 to 1050.3)

Base Study: 9- to 15-Year-Old Females (Lot 1) vs Base Study: 9- to 15-Year-Old Females (Lot 2): GMT ratio: 0.97 (95% CI 0.88 to 1.08)
Base Study: 9- to 15-Year-Old Females (Lot 1) vs Base Study: 9- to 15-Year-Old Females (Lot 3): GMT ratio: 1.03 (95% CI 0.93 to 1.16)
Base Study: 9- to 15-Year-Old Females (Lot 2) vs Base Study: 9- to 15-Year-Old Females (Lot 3): GMT ratio: 1.06 (95% CI 0.95 to 1.19)

Population analysed: 9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.

Primary outcome: Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)

Time frame: Up to 5 days after any vaccination. Number. Unit: Percentage of Participants

Measure	9- to 15-Year-Old Females (Lots 1, 2 or 3) n = 1923	Base Study: 9- to 15-Year-Old Males (Lot 1) n = 662	Base Study: 16- to 26-Year-Old Females (Lot 1) n = 466
Value	81.9	72.8	85.4

Population analysed: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Base Study: Up to ~12 months; Extension Study: Up to ~126 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Base Study: 9- to 15-Year-Old Females (Lot 1)	6 of 643 (0.9%)	538 of 643 (83.7%)	0 of 648
Base Study: 9- to 15-Year-Old Females (Lot 2)	2 of 639 (0.3%)	537 of 639 (84%)	0 of 643
Base Study: 9- to 15-Year-Old Females (Lot 3)	8 of 641 (1.2%)	554 of 641 (86.4%)	0 of 644
Base Study: 9- to 15-Year-Old Males (Lot 1)	11 of 662 (1.7%)	505 of 662 (76.3%)	0 of 669
Base Study: 16- to 26-Year-Old Females (Lot 1)	15 of 466 (3.2%)	404 of 466 (86.7%)	0 of 470
EXT1: 9- to 15-Year-Old Females	2 of 1,604 (0.1%)	0 of 1,604 (0%)	1 of 1,604
EXT1: 9- to 15-Year-Old Males	0 of 568 (0%)	0 of 568 (0%)	0 of 568
EXT2: 9- to 15-Year-Old Females	3 of 971 (0.3%)	0 of 971 (0%)	1 of 971
EXT2: 9- to 15-Year-Old Males	0 of 301 (0%)	0 of 301 (0%)	0 of 301

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26086587Luxembourg A, Moreira ED Jr, Samakoses R, Kim KH, Sun X, Maansson R, Moeller E, Christiano S, Chen J. Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine. Hum Vaccin Immunother. 2015;11(6):1306-12. doi: 10.1080/21645515.2015.1009819.
Results publication: PubMed 26101366Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang LM, Kim DS, Pitisuttithum P, Chen J, Christiano S, Maansson R, Moeller E, Sun X, Vuocolo S, Luxembourg A. Immunogenicity and Safety of a 9-Valent HPV Vaccine. Pediatrics. 2015 Jul;136(1):e28-39. doi: 10.1542/peds.2014-3745.
Results publication: PubMed 27422279Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.
Results publication: PubMed 32659510Olsson SE, Restrepo JA, Reina JC, Pitisuttithum P, Ulied A, Varman M, Van Damme P, Moreira ED Jr, Ferris D, Block S, Bautista O, Gallagher N, McCauley J, Luxembourg A. Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up. Papillomavirus Res. 2020 Dec;10:100203. doi: 10.1016/j.pvr.2020.100203. Epub 2020 Jul 11.
Derived from this study: PubMed 37667847Restrepo J, Herrera T, Samakoses R, Reina JC, Pitisuttithum P, Ulied A, Bekker LG, Moreira ED, Olsson SE, Block SL, Hammes LS, Laginha F, Ferenczy A, Kurman R, Ronnett BM, Stoler M, Bautista O, Gallagher NE, Salituro G, Ye M, Luxembourg A. Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety. Pediatrics. 2023 Oct 1;152(4):e2022060993. doi: 10.1542/peds.2022-060993.
Derived from this study: PubMed 29767739Garland SM, Pitisuttithum P, Ngan HYS, Cho CH, Lee CY, Chen CA, Yang YC, Chu TY, Twu NF, Samakoses R, Takeuchi Y, Cheung TH, Kim SC, Huang LM, Kim BG, Kim YT, Kim KH, Song YS, Lalwani S, Kang JH, Sakamoto M, Ryu HS, Bhatla N, Yoshikawa H, Ellison MC, Han SR, Moeller E, Murata S, Ritter M, Sawata M, Shields C, Walia A, Perez G, Luxembourg A. Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries. J Infect Dis. 2018 Jun 5;218(1):95-108. doi: 10.1093/infdis/jiy133.
Derived from this study: PubMed 29269325Ruiz-Sternberg AM, Moreira ED Jr, Restrepo JA, Lazcano-Ponce E, Cabello R, Silva A, Andrade R, Revollo F, Uscanga S, Victoria A, Guevara AM, Luna J, Plata M, Dominguez CN, Fedrizzi E, Suarez E, Reina JC, Ellison MC, Moeller E, Ritter M, Shields C, Cashat M, Perez G, Luxembourg A. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Res. 2018 Jun;5:63-74. doi: 10.1016/j.pvr.2017.12.004. Epub 2017 Dec 19.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503 in people with Cervical Cancers and Vulvar Cancer, run by Merck Sharp & Dohme LLC.

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 5 inclusion and 16 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: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 13 Jan 2015). 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?

Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) (time frame: 4 weeks post-vaccination 3 (Month 7)). The study lists 8 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 NCT00943722, 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 3 Oct 2022.