NCT01254643

A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Completed Phase 3 Results posted Last updated 28 November 2018

What this trial tests

Phase 3 trial testing V503 in Papillomavirus Infections in 100 participants. Completed in 10 August 2013.

Timeline

12 January 2011

Primary endpoint
10 August 2013

10 August 2013

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	12 January 2011
Primary completion	10 August 2013
Estimated completion	10 August 2013

Drugs / interventions tested

• V503 — full drug profile →

Conditions studied

• Papillomavirus Infections — all drugs for Papillomavirus Infections →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 9 to 15, female only, with Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine Primary · 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 competitive luminex immunoassay (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.

Anti-HPV 6 (n=97)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 11 (n=97)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 16 (n=99)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 18 (n=98)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 31 (n=97)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 33 (n=98)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 45 (n=99)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Anti-HPV 52 (n=99)

Group	Value	95% CI
All Enrolled	100	96.3 – 100

Percentage of Participants With an Injection-site Adverse Event (AE) Primary · up to 5 days after any vaccination

An AE is 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 is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.

Group	Value	95% CI
All Enrolled	95.0

Percentage of Participants With a Non-Injection Site (Systemic) AE Primary · up to 15 days after any vaccination

An AE is 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 is also an AE. Systemic AEs were those not categorized as injection-site AEs.

Group	Value	95% CI
All Enrolled	35.0

Percentage of Participants With a Vaccine-related AE Primary · up to 15 days after any vaccination

An AE is 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 is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.

Group	Value	95% CI
All Enrolled	96.0

Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine Secondary · 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 cLIA. Titers are reported in milli Merck Units/mL.

Anti-HPV 6 (n=97)

Group	Value	95% CI
All Enrolled	1836.5	1597.7 – 2111.0

Anti-HPV 11 (n=97)

Group	Value	95% CI
All Enrolled	1331.3	1135.0 – 1561.4

Anti-HPV 16 (n=99)

Group	Value	95% CI
All Enrolled	6823.6	5907.9 – 7881.2

Anti-HPV 18 (n=98)

Group	Value	95% CI
All Enrolled	2159.9	1803.8 – 2586.3

Anti-HPV 31 (n=97)

Group	Value	95% CI
All Enrolled	2052.5	1735.9 – 2426.8

Anti-HPV 33 (n=98)

Group	Value	95% CI
All Enrolled	994.8	857.2 – 1154.4

Anti-HPV 45 (n=99)

Group	Value	95% CI
All Enrolled	811.0	679.7 – 967.6

Anti-HPV 52 (n=99)

Group	Value	95% CI
All Enrolled	1069.1	908.4 – 1258.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Enrolled

Serious: 0/100 (0%)

Deaths: —

Other adverse events (6 terms — click to expand)

Reaction	System	All Enrolled
Injection site pain	General disorders	—
Injection site swelling	General disorders	—
Injection site erythema	General disorders	—
Nasopharyngitis	Infections and infestations	—
Headache	Nervous system disorders	—
Pyrexia	General disorders	—

Data from ClinicalTrials.gov NCT01254643 adverse events section.

Sponsor's own description

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Virus-like particle vaccinology, from bench to bedside.
   Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8
2. Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence.
   Signorelli C, Odone A, Ciorba V, Cella P, et al · · 2017 · cited 44× · PMID 28446260 · DOI 10.1017/s0950268817000747
3. Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries.
   Garland SM, Pitisuttithum P, Ngan HYS, Cho CH, et al · · 2018 · cited 35× · PMID 29767739 · DOI 10.1093/infdis/jiy133
4. Targeting lymph node delivery with nanovaccines for cancer immunotherapy: recent advances and future directions.
   Li Y, Li S, Jiang Z, Tan K, et al · · 2023 · cited 21× · PMID 37415161 · DOI 10.1186/s12951-023-01977-1
5. Cross-sectional and longitudinal analysis of cancer vaccination trials registered on the US Clinical Trials Database demonstrates paucity of immunological trial endpoints and decline in registration since 2008.
   Lu L, Yan H, Shyam-Sundar V, Janowitz T. · · 2014 · cited 17× · PMID 25302014 · DOI 10.2147/dddt.s65963