Clinical Trial Results:
A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-
Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™
Summary
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EudraCT number |
2009-015500-26 |
Trial protocol |
SE DK Outside EU/EEA |
Global end of trial date |
28 Nov 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2016
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First version publication date |
04 Jun 2016
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Other versions |
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 |
V503-006
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01047345 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Merck Registration Number: 2010_504 | ||
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 |
28 Nov 2015
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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 |
28 Nov 2015
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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 |
This study will evaluate whether V503 (9vHPV vaccine) is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.
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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 |
24 Feb 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Australia: 3
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Country: Number of subjects enrolled |
Canada: 70
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Country: Number of subjects enrolled |
Colombia: 151
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Country: Number of subjects enrolled |
Denmark: 303
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Country: Number of subjects enrolled |
Hong Kong: 46
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Country: Number of subjects enrolled |
Mexico: 20
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Country: Number of subjects enrolled |
Puerto Rico: 12
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Country: Number of subjects enrolled |
Sweden: 105
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Country: Number of subjects enrolled |
United States: 214
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Worldwide total number of subjects |
924
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EEA total number of subjects |
408
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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) |
0
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Adolescents (12-17 years) |
331
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Adults (18-64 years) |
593
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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 |
- | |||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Healthy female participants Age 12 to 26 who received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1. Other inclusion and exclusion criteria applied. | |||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Base Study
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer | |||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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9vHPV Vaccine- Base Study | |||||||||||||||||||||||||||||||||
Arm description |
9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
9vHPV Vaccine
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Investigational medicinal product code |
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Other name |
V503
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
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Arm title
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Placebo - Base Study | |||||||||||||||||||||||||||||||||
Arm description |
0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. | |||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
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Period 2
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Period 2 title |
Extension
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||
Arms
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Arm title
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9vHPV Vaccine -Extension | |||||||||||||||||||||||||||||||||
Arm description |
Participants who received placebo in base study and elected to have 9vHPV vaccination in extension. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
9vHPV Vaccine
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Investigational medicinal product code |
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Other name |
V503
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Participation in the extension was voluntary. Not all eligible participants elected to enter the extension. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: One participant received 3rd 9vHPV vaccination outside the context of the study and therefore was not eligible to receive 3rd dose as part of the study. Participant remained in the study, was followed for safety to study completion. |
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Baseline characteristics reporting groups
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Reporting group title |
9vHPV Vaccine- Base Study
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Reporting group description |
9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo - Base Study
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Reporting group description |
0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. | ||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
9vHPV Vaccine- Base Study
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Reporting group description |
9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study | ||
Reporting group title |
Placebo - Base Study
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Reporting group description |
0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. | ||
Reporting group title |
9vHPV Vaccine -Extension
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Reporting group description |
Participants who received placebo in base study and elected to have 9vHPV vaccination in extension. | ||
Subject analysis set title |
9vHPV Vaccine - Efficacy
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with the immune response to the vaccine.
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Subject analysis set title |
Placebo - Efficacy
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with the immune response to the vaccine.
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End point title |
Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study [1] | ||||||||||||
End point description |
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. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 5 days after any vaccination - Base Study
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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: No statistical analysis was planned or performed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants with Body Temperature ≥100.0°F (≥37.8ºC) – Base Study | ||||||||||||
End point description |
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. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 5 days after any vaccination - Base Study
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Statistical analysis title |
Comparison of Difference in Percentages | ||||||||||||
Statistical analysis description |
Comparison based on Miettinen & Nurminen method
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Comparison groups |
9vHPV Vaccine- Base Study v Placebo - Base Study
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Number of subjects included in analysis |
908
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
= 0.026 | ||||||||||||
Method |
Miettinen & Nurminen | ||||||||||||
Parameter type |
Difference in Percentages | ||||||||||||
Point estimate |
3.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.5 | ||||||||||||
upper limit |
6.2 |
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End point title |
Percentage of Participants Who Experience a Systemic AE – Base Study | ||||||||||||
End point description |
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. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 14 days after any vaccination - Base Study
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Statistical analysis title |
Comparison of Difference in Percentages | ||||||||||||
Statistical analysis description |
Analysis was performed based on Miettinen & Nurminen method
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Comparison groups |
9vHPV Vaccine- Base Study v Placebo - Base Study
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Number of subjects included in analysis |
913
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Difference in Percentages | ||||||||||||
Point estimate |
4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.8 | ||||||||||||
upper limit |
10.8 |
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End point title |
Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of any Vaccination – Base Study | ||||||||||||
End point description |
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 14 days after any vaccination - Base Study
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Statistical analysis title |
Comparison of Difference in Percentages | ||||||||||||
Statistical analysis description |
Analysis was performed based on Miettinen & Nurminen method
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Comparison groups |
9vHPV Vaccine- Base Study v Placebo - Base Study
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Number of subjects included in analysis |
913
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Difference in Percentages | ||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.5 | ||||||||||||
upper limit |
0.9 |
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End point title |
Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study– Base Study | ||||||||||||
End point description |
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” is defined as a vaccine-related SAE. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 7 months - Base Study
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Statistical analysis title |
Comparison of Difference in Percentages | ||||||||||||
Statistical analysis description |
Analysis was performed based on Miettinen & Nurminen method
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Comparison groups |
9vHPV Vaccine- Base Study v Placebo - Base Study
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Number of subjects included in analysis |
913
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Difference in Percentages | ||||||||||||
Point estimate |
-0.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.7 | ||||||||||||
upper limit |
0.6 |
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End point title |
Percentage of Participants Who Experience a Severe Injection-site AE – Base Study | ||||||||||||
End point description |
An AE is 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized. Analysis population included all participants who received at least 1 vaccination and had follow-up safety data.
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End point type |
Primary
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End point timeframe |
up to 5 days after any vaccination - Base Study
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Statistical analysis title |
Comparison of Difference in Percentages | ||||||||||||
Statistical analysis description |
Comparison based on Miettinen & Nurminen method
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Comparison groups |
9vHPV Vaccine- Base Study v Placebo - Base Study
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Number of subjects included in analysis |
913
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Difference in Percentages | ||||||||||||
Point estimate |
10.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
7.5 | ||||||||||||
upper limit |
13.1 |
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End point title |
Percentage of Participants who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study | |||||||||||||||||||||||||||||||||||||||
End point description |
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. Analysis population included all participants that received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with the immune response to the vaccine.
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End point type |
Secondary
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End point timeframe |
4 weeks post-vaccination 3 (Month 7; End of Base Study)
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No statistical analyses for this end point |
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End point title |
Percentage of Participants Who Experience an SAE- Extension Study | ||||||||
End point description |
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
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End point type |
Other pre-specified
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End point timeframe |
up to Month 7 - Extension Study
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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 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study; up to 7 months-Extension
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Adverse event reporting additional description |
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the extension. Although some unsolicited non-serious AEs were reported, none exceeded the 5% cut-off.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
9vHPV Vaccine- Base Study
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Reporting group description |
9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
9vHPV Vaccine- Extension
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Reporting group description |
Participants who received placebo in base study and elected to have 9vHPV vaccination in extension. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo - Base Study
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Reporting group description |
0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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07 Jan 2014 |
Amendment 2: Added extension study. Participants who received placebo in the base study could elect to receive the 9vHPV vaccine in the extension. |
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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. | |||
None reported |