Clinical Trial Results:
A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-olds)
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Summary
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EudraCT number |
2010-023393-39 |
Trial protocol |
FI BE SE ES DK IT |
Global end of trial date |
20 Dec 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Apr 2016
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First version publication date |
02 Aug 2015
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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 |
GDS01C
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01304498 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur MSD S.N.C.
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Sponsor organisation address |
162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
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Public contact |
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
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Scientific contact |
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000654-PIP01-09 | ||
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 |
20 Dec 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Dec 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Dec 2011
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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 |
To demonstrate that administration of the 9-valent HPV L1 VLP (9vHPV) vaccine induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 16 and anti-HPV 18 compared to GARDASIL® (qHPV) in preadolescent and adolescent girls 9 to 15 years of age.
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Protection of trial subjects |
Healthy girls with known allergy to any vaccine component were excluded.
Vaccines were administered by qualified study personnel.
After each vaccination, subjects were kept under observation for at least 30 minutes to ensure their safety.
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Background therapy |
- | ||
Evidence for comparator |
# 9vHPV vaccine (= V503) is a prophylactic 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) L1 virus-like particle (VLP) vaccine that is composed of VLPs of the 4 HPV types (Type 6, 11, 16, and 18) contained in qHPV vaccine (= GARDASIL®, a quadrivalent prophylactic HPV vaccine), plus the VLPs of 5 additional oncogenic HPV types (Types 31, 33, 45, 52, and 58). # qHPV vaccine has been approved by the European Medicines Agency (EMA) in September 2006 and is currently approved and marketed in over 100 countries. # This study was designed to provide a direct comparison of immunogenicity and safety/tolerability of the 9vHPV vaccine versus qHPV vaccine in preadolescent and adolescent girls, 9 to 15 years of age. | ||
Actual start date of recruitment |
23 Feb 2011
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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 |
Spain: 89
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Country: Number of subjects enrolled |
Sweden: 122
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Country: Number of subjects enrolled |
Belgium: 96
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Country: Number of subjects enrolled |
Denmark: 69
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Country: Number of subjects enrolled |
Finland: 150
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Country: Number of subjects enrolled |
Italy: 74
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Worldwide total number of subjects |
600
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EEA total number of subjects |
600
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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) |
246
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Adolescents (12-17 years) |
354
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Adults (18-64 years) |
0
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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 |
Study subjects were enrolled in 24 active centres in 6 European countries (Belgium, Denmark, Finland, Italy, Spain, and Sweden) between 23 February 2011 and 11 May 2011. | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
603 subjects were screened. 600 subjects were randomised. 592 subjects received all 3 doses of 9vHPV or qHPV vaccine. 589 subjects completed the study. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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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 | ||||||||||||||||||||||||
Blinding implementation details |
Blinded vaccines had visually identical presentations and were presented in an indistinguishable packaging.
The subjects, investigators (and his/her staff), laboratory staff, and sponsor remained blinded to subject vaccine allocation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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9vHPV vaccine | ||||||||||||||||||||||||
Arm description |
# Subjects received 3 doses of 9vHPV vaccine* by intramuscular (IM) route: dose 1 at Visit 1 (V1, Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *9vHPV vaccine = V503 = 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) L1 virus-like particle (VLP) vaccine (recombinant, absorbed) | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
9-valent HPV VLP
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Investigational medicinal product code |
9vHPV
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Other name |
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, IM route (deltoid muscle of the nondominant arm), 3 doses: dose 1 at V1 (Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks).
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Arm title
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qHPV vaccine | ||||||||||||||||||||||||
Arm description |
# Subjects received 3 doses of qHPV vaccine* by intramuscular (IM) route: dose 1 at V1 (Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *qHPV vaccine = GARDASIL® = 4-valent HPV (Types 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine (Recombinant, absorbed) | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
GARDASIL®
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Investigational medicinal product code |
qHPV
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Other name |
SILGARD®
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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, IM route (deltoid muscle of the nondominant arm), 3 doses: dose 1 at V1 (Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks).
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Baseline characteristics reporting groups
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Reporting group title |
9vHPV vaccine
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Reporting group description |
# Subjects received 3 doses of 9vHPV vaccine* by intramuscular (IM) route: dose 1 at Visit 1 (V1, Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *9vHPV vaccine = V503 = 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) L1 virus-like particle (VLP) vaccine (recombinant, absorbed) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
qHPV vaccine
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Reporting group description |
# Subjects received 3 doses of qHPV vaccine* by intramuscular (IM) route: dose 1 at V1 (Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *qHPV vaccine = GARDASIL® = 4-valent HPV (Types 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine (Recombinant, absorbed) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
9vHPV vaccine
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Reporting group description |
# Subjects received 3 doses of 9vHPV vaccine* by intramuscular (IM) route: dose 1 at Visit 1 (V1, Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *9vHPV vaccine = V503 = 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) L1 virus-like particle (VLP) vaccine (recombinant, absorbed) | ||
Reporting group title |
qHPV vaccine
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Reporting group description |
# Subjects received 3 doses of qHPV vaccine* by intramuscular (IM) route: dose 1 at V1 (Day 1), dose 2 at V2 (2 months after Day 1, ±3 weeks), and dose 3 at V3 (6 months after Day 1, ±4 weeks). # Subjects were blood sampled (i) before vaccination (V1), and (ii) at V4, i.e., 3 to 7 weeks after V3 = Post-Dose 3. *qHPV vaccine = GARDASIL® = 4-valent HPV (Types 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine (Recombinant, absorbed) | ||
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End point title |
Non-inferiority of Geometric Mean Titres (GMTs) of anti-HPV types 16 and 18 antibodies (Abs) Post-Dose 3 (V4) of 9vHPV versus qHPV vaccine | ||||||||||||||||||
End point description |
Anti-HPV types 16 and 18 Ab titres were measured by competitive Luminex ImmunoAssay (cLIA) 3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
Ab titres are expressed in milli Merck units (mMU)/mL.
Analysis was done on the HPV specific Per Protocol Sets (PPS), i.e., subjects who received all 3 vaccinations, and seronegative to the relevant HPV type at Day 1, excluding those with protocol deviation which could interfere with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "9vHPV vaccine" and "qHPV vaccine" groups, respectively.
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End point type |
Primary
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End point timeframe |
3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
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Statistical analysis title |
Non-inferiority for HPV 16 | ||||||||||||||||||
Statistical analysis description |
The estimate of the 9vHPV vaccine/qHPV vaccine GMT ratio for HPV 16 was calculated with its P-value and its 2-sided 95% confidence interval (CI) using an ANOVA model including group and age stratum as independent variables.
If the lower bound of the 95% CI was greater than 0.67 (i.e., the non-inferiority margin), it was concluded that 9vHPV GMT was non-inferior to qHPV GMT.
Analysis was done on the HPV 16 specific PPS. N= 546 (9vHPV vaccine: 276, qHPV vaccine: 270).
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Comparison groups |
9vHPV vaccine v qHPV vaccine
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Number of subjects included in analysis |
546
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
0.97
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.85 | ||||||||||||||||||
upper limit |
1.11 | ||||||||||||||||||
Statistical analysis title |
Non-inferiority for HPV 18 | ||||||||||||||||||
Statistical analysis description |
The estimate of the 9vHPV vaccine/qHPV vaccine GMT ratio for HPV 18 was calculated with its P-value and its 2-sided 95% confidence interval (CI) using an ANOVA model including group and age stratum as independent variables.
If the lower bound of the 95% CI was greater than 0.67 (i.e., the non-inferiority margin), it was concluded that 9vHPV GMT was non-inferior to qHPV GMT.
Analysis was done on the HPV 18 specific PPS. N= 545 (9vHPV vaccine: 276, qHPV vaccine: 269).
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Comparison groups |
9vHPV vaccine v qHPV vaccine
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Number of subjects included in analysis |
546
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
1.08
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.91 | ||||||||||||||||||
upper limit |
1.29 | ||||||||||||||||||
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End point title |
Comparison of GMTs of anti-HPV types 6 and 11 Abs Post-Dose 3 (V4) of 9vHPV or qHPV vaccine | ||||||||||||||||||
End point description |
Anti-HPV types 6 and 11 Ab titres were measured by cLIA 3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
Ab titres are expressed in mMU/mL.
Analysis was done on the HPV specific Per Protocol Sets (PPS), i.e., subjects who received all 3 vaccinations, and seronegative to the relevant HPV type at Day 1, excluding those with protocol deviation which could interfere with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "9vHPV vaccine" and "qHPV vaccine" groups, respectively.
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End point type |
Secondary
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End point timeframe |
3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
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Statistical analysis title |
9vHPV/qHPV GMT ratio for HPV 6 | ||||||||||||||||||
Statistical analysis description |
The estimate of the 9vHPV vaccine/qHPV vaccine GMT ratio for HPV 6 was calculated with its 2-sided 95% confidence interval (CI) using an ANOVA model including group and age stratum as independent variables.
Analysis was done on the HPV 6 specific PPS. N= 534 (9vHPV vaccine: 273, qHPV vaccine: 261).
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Comparison groups |
9vHPV vaccine v qHPV vaccine
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Number of subjects included in analysis |
534
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||
Method |
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Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
1.07
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.93 | ||||||||||||||||||
upper limit |
1.23 | ||||||||||||||||||
Statistical analysis title |
9vHPV/qHPV GMT ratio for HPV 11 | ||||||||||||||||||
Statistical analysis description |
The estimate of the 9vHPV vaccine/qHPV vaccine GMT ratio for HPV 11 was calculated with its 2-sided 95% confidence interval (CI) using an ANOVA model including group and age stratum as independent variables.
Analysis was done on the HPV 11 specific PPS. N= 534 (9vHPV vaccine: 273, qHPV vaccine: 261).
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Comparison groups |
9vHPV vaccine v qHPV vaccine
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Number of subjects included in analysis |
534
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||
Method |
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Parameter type |
GMT ratio | ||||||||||||||||||
Point estimate |
0.93
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
0.8 | ||||||||||||||||||
upper limit |
1.08 | ||||||||||||||||||
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End point title |
Seroconversion rates for anti-HPV types 6, 11, 16, and 18 Abs Post-Dose 3 (V4) of 9vHPV or qHPV vaccine | ||||||||||||||||||||||||
End point description |
The seroconversion rates to HPV types 6, 11, 16, and 18 defined as Ab titres ≥30 mMU/mL for anti-HPV 6, ≥16 mMU/mL for anti-HPV 11, ≥20 mMU/mL for anti-HPV 16, and ≥24 mMU/mL for anti-HPV 18 were determined 3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
Ab titres were measured by cLIA.
Analysis was done on the HPV specific Per Protocol Sets (PPS), i.e., subjects who received all 3 vaccinations, and seronegative to the relevant HPV type at Day 1, excluding those with protocol deviation which could interfere with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "9vHPV vaccine" and "qHPV vaccine" groups, respectively.
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End point type |
Secondary
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End point timeframe |
3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Global summary of safety from D1 to D15 after any vaccination (3 doses of 9vHPV or qHPV) | |||||||||||||||||||||||||||||||||
End point description |
Adverse events (AEs) were recorded as follows.
1/ From D1 to D5 after each vaccination: # oral temperature ≥37.8°C, # solicited (erythema, pain, and swelling at injection-site) and # other injection-site adverse reactions (ISRs).
2/ From D1 to D15 after each vaccination: systemic AEs.
AEs at injection sites were always considered as related to vaccine (ISRs). The investigator had to assess whether systemic AEs were vaccine-related systemic AEs or not.
The percentage of subjects presenting at least once the considered events after any vaccination is reported hereafter.
Analyses following any doses were based on the vaccines corresponding to the highest number of doses received by the subject.
Analysis was done on the Safety Set, i.e., all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data.
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End point type |
Secondary
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End point timeframe |
From Day 1 (D1) to D15 after any vaccination (3 doses of 9vHPV or qHPV).
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
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End point title |
Percentage of subjects reporting ISRs from D1 to D5 after any vaccination (3 doses of 9vHPV or qHPV) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The percentage of subjects presenting at least once solicited (erythema, pain, and swelling) or other ISRs from D1 to D5 after any vaccination (3 doses of 9vHPV or qHPV) is reported hereafter.
AEs at injection-site were always considered as related to vaccine (ISRs).
Analyses following any doses were based on the vaccines corresponding to the highest number of doses received by the subject.
Analysis was done on the Safety Set, i.e., all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data.
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End point type |
Secondary
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End point timeframe |
From Day 1 (D1) to D5 after any vaccination (3 doses of 9vHPV or qHPV).
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of subjects reporting oral temperature [37.8°C-38.9°C[ or [38.9°C-39.9°C[ from D1 to D5 after any vaccination (3 doses of 9vHPV or qHPV) | ||||||||||||||||||
End point description |
Maximum oral temperatures recorded daily were reported from D1 to D5 after any vaccination (3 doses of 9vHPV or qHPV).
The percentage of subjects presenting at least once oral temperature [37.8°C-38.9°C[ or [38.9°C-39.9°C[ is presented hereafter.
Analyses following any doses were based on the vaccines corresponding to the highest number of doses received by the subject.
Analysis was done on the Safety Set, i.e., all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data.
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End point type |
Secondary
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End point timeframe |
From Day 1 (D1) to D5 after any vaccination (3 doses of 9vHPV or qHPV).
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
GMTs of anti-HPV types 31, 33, 45, 52, and 58 Abs Post-Dose 3 (V4) of 9vHPV or qHPV vaccine | |||||||||||||||||||||||||||
End point description |
Anti-HPV types 31, 33, 45, 52, and 58 Ab titres were measured by cLIA 3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
Ab titres are expressed in mMU/mL.
Analysis was done on the HPV specific Per Protocol Sets (PPS), i.e., subjects who received all 3 vaccinations, and seronegative to the relevant HPV type at Day 1, excluding those with protocol deviation which could interfere with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "9vHPV vaccine" and "qHPV vaccine" groups, respectively.
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End point type |
Other pre-specified
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End point timeframe |
3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Seroconversion rates for anti-HPV types 31, 33, 45, 52, and 58 Abs Post-Dose 3 (V4) of 9vHPV or qHPV vaccine | |||||||||||||||||||||||||||
End point description |
The seroconversion rates to HPV types 31, 33, 45, 52, and 58 defined as Ab titres ≥10 mMU/mL for anti-HPV 31, and ≥8 mMU/mL for anti-HPV 33, 45, 52, and 58 were determined 3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
Ab titres were measured by cLIA.
Analysis was done on the HPV specific Per Protocol Sets (PPS), i.e., subjects who received all 3 vaccinations, and seronegative to the relevant HPV type at Day 1, excluding those with protocol deviation which could interfere with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "9vHPV vaccine" and "qHPV vaccine" groups, respectively.
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End point type |
Other pre-specified
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End point timeframe |
3 to 7 weeks Post-Dose 3 of 9vHPV or qHPV vaccine (V4).
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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 |
Systemic adverse events (AEs) were collected from D1 to D15 after each dose of 9vHPV or qHPV vaccine.
Serious AEs and deaths were collected throughout the study.
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Adverse event reporting additional description |
Analysis of AEs was done on the Safety Set, i.e., all subjects who received at least 1 dose of the study vaccines and who had safety follow-up data.
Unsolicited non-serious systemic AEs (vaccine-related or not) with incidence ≥1% are presented hereafter.
None of the serious AEs were vaccine-related.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
9vHPV vaccine
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Reporting group description |
# Subjects received 3 doses of 9vHPV vaccine (V503) by IM route: dose 1 at Visit 1 (Day 1), dose 2 at Visit 2 (2 months after Day 1, ±3 weeks), and dose 3 at Visit 3 (6 months after Day 1, ±4 weeks). # Respectively, 142 (47.5%) subjects reported at least 1 unsolicited systemic AE, and 62 (20.7%) subjects reported at least 1 vaccine-related unsolicited systemic AE within 15 days after any vaccination (3 doses of 9vHPV vaccine). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
qHPV vaccine
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Reporting group description |
# Subjects received 3 doses of qHPV vaccine (GARDASIL®) by IM route: dose 1 at Visit 1 (Day 1), dose 2 at Visit 2 (2 months after Day 1, ±3 weeks), and dose 3 at Visit 3 (6 months after Day 1, ±4 weeks). # Respectively, 156 (52.0%) subjects reported at least 1 unsolicited systemic AE, and 73 (24.3%) subjects reported at least 1 vaccine-related unsolicited systemic AE within 15 days after any vaccination (3 doses of qHPV vaccine). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
