NCT03158220 · REGISTRY CONDITION SEARCH

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2019-11-21

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type

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outcome · POSTED

Percentage of Participants That Experienced at Least 1 Adverse Event (AE)

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outcome · POSTED

Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.

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outcome · POSTED

Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event

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outcome · POSTED

Percentage of Participants That Reported at Least 1 Systemic Adverse Event

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outcome · POSTED

Percentage of Participants With Elevated Temperature (Fever)

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outcome · POSTED

Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * good physical health Exclusion Criteria: * history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results * history of HPV-related condition * history of known prior vaccination with an HPV vaccine * pregnant * user of recreational or illicit drugs * history of severe allergic reaction, including known allergy to any vaccine component * immunocompromised * history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent) * has thrombocytopenia or other coagulation disorder * concurrently enrolled in a clinical study of investigational agent
healthy Volunteers: true
maximum Age: 45 Years
minimum Age: 16 Years
sex: FEMALE
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Adult women 27- to 45-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
intervention Names
Biological: V503
label
Adult Women 27- to 45-years Old
type
EXPERIMENTAL
description
Young adult women 16- to 26-years old will receive V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
intervention Names
Biological: V503
label
Young Adult Women 16- to 26-years Old
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Adult Women 27- to 45-years Old
Young Adult Women 16- to 26-years Old
description
V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
name
V503
other Names
GARDASIL®9 (HPV 9-valent vaccine [recombinant, adsorbed]); HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

PREVENTION

Enrollment

count: 1212
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
measure
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type
time Frame
4 weeks post vaccination 3 (Month 7)

secondary Outcomes

description
An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
measure
Percentage of Participants That Experienced at Least 1 Adverse Event (AE)
time Frame
Up to 1 month post vaccination 3 (up to 7 months)
description
An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.
measure
Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.
time Frame
Up to 1 month post vaccination 3 (up to 7 months)
description
Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
measure
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
time Frame
Up to 5 days post any vaccination
description
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
measure
Percentage of Participants That Reported at Least 1 Systemic Adverse Event
time Frame
Up to 15 days post any vaccination
description
Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.
measure
Percentage of Participants With Elevated Temperature (Fever)
time Frame
Up to 5 days post any vaccination
description
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.
measure
Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types
time Frame
4 weeks post vaccination 3 (Month 7)

Full study description

brief Summary: This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Source references

references

citation
Joura EA, Ulied A, Vandermeulen C, Rua Figueroa M, Seppa I, Hernandez Aguado JJ, Ahonen A, Reich O, Virta M, Perino A, Peris Tuser M, Peters K, Origoni M, Raspagliesi F, Tjalma WAA, Tummers P, Woelber L, Nieminen P, van Damme P, Sehouli J, Fiol Ruiz G, Brucker S, Fehm T, Cheon K, Rawat S, Luxembourg A, Wittke F. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study. Vaccine. 2021 May 12;39(20):2800-2809. doi: 10.1016/j.vaccine.2021.01.074. Epub 2021 Mar 3.
pmid
33676783
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice