Clinical Trial Results:
A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26 Year-Old Females and Males in Vietnam
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Summary
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EudraCT number |
2017-001205-33 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Jan 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Sep 2019
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First version publication date |
22 Sep 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V503-017
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03546842 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Jan 2019
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jan 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The trial was conducted to assess immunogenicity and safety of the 9-valent human papillomavirus (9vHPV) vaccine in participants from Vietnam.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jun 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Vietnam: 201
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Worldwide total number of subjects |
201
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
41
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Adolescents (12-17 years) |
99
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Adults (18-64 years) |
61
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Healthy females or males between the ages of 9 years and 26 years were enrolled in the study. Other inclusion and exclusion criteria applied. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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9vHPV Vaccine | ||||||||||||||||||
Arm description |
Participants received a single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
9-valent Human Papillomavirus (9vHPV) [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] L1 Virus-Like Particle (VLP) Recombinant Vaccine
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Investigational medicinal product code |
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Other name |
Gardasil™9; V503
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL intramuscualr injection at Day 1, Month 2 and Month 6
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Baseline characteristics reporting groups
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Reporting group title |
9vHPV Vaccine
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Reporting group description |
Participants received a single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
9vHPV Vaccine
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Reporting group description |
Participants received a single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 | ||
Subject analysis set title |
9vHPV Vaccine-Immunogenicity
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol immunogenicity (PPI) population was HPV type-specific and consisted of all allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose of 9vHPV vaccine within acceptable day ranges, provided a serum sample within 21 to 49 days post-dose 3, and had no protocol deviations that could interfere with the evaluation of participant’s immune response to 9vHPV vaccination.
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Subject analysis set title |
9vHPV Vaccine-Safety
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All participants that received at least 1 vaccination with V503 and provided safety data at any time during the study.
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End point title |
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 [1] | ||||||||||||||||||||||||||
End point description |
Seroconversion is defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies are measured using a Competitive Luminex Immunoassay.
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End point type |
Primary
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End point timeframe |
4 weeks postdose 3 (Month 7)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: System does not allow the posting of the analysis of a single arm study. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Participants with a Solicited Injection-site Adverse Event | ||||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
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End point type |
Secondary
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End point timeframe |
Up to 5 days after any vaccination
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with a Solicited Systemic Adverse Event | ||||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could 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 was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant will be asked to record the participant’s oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature [(≥ 37.8 °C (100.0 °F)] was summarized.
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End point type |
Secondary
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End point timeframe |
Up to 5 days after any vaccination
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with a Vaccine-related Serious Adverse Event | ||||||||
End point description |
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least SAE that was reported as at least possibly related to the study vaccine was summarized.
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End point type |
Secondary
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End point timeframe |
Up to 4 weeks postdose 3 (Month 7)
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| No statistical analyses for this end point | |||||||||
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End point title |
Geometric Mean Titers of Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 | ||||||||||||||||||||||||||
End point description |
Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.
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End point type |
Secondary
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End point timeframe |
4 weeks postdose 3 (Month 7)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 4 weeks postdose 3 (Month 7)
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Adverse event reporting additional description |
Population included all participants that received at least 1 vaccination with V503 and provided safety data at any time during the study.
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Assessment type |
Systematic | ||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
V503
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Reporting group description |
- | ||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Dec 2017 |
Amendment 1: Primary reason for the amendment was to remove sections and text pertaining to Future Biomedical Research samples. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Due to limitations in the EudraCT reporting system, the Predose GMTs could not be reported as planned. Almost all titers were < the lower limit of quantification. The results for this endpoint will be posted on ClinicalTrials.gov (NCT03546842). | |||
