Trial Outcomes & Findings for Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED) (NCT NCT00365716)
NCT ID: NCT00365716
Last Updated: 2015-10-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1158 participants
Primary outcome timeframe
Days 1-5 following any vaccination visit
Results posted on
2015-10-07
Participant Flow
Participant milestones
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Extension 1
This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered \~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
|
Extension 2
This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
|
|---|---|---|---|---|---|---|---|
|
Base Study (Day 1 to Month 7)
STARTED
|
290
|
284
|
292
|
146
|
146
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
COMPLETED
|
269
|
260
|
271
|
136
|
139
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
NOT COMPLETED
|
21
|
24
|
21
|
10
|
7
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
STARTED
|
269
|
260
|
271
|
136
|
139
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
COMPLETED
|
137
|
245
|
251
|
57
|
57
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
NOT COMPLETED
|
132
|
15
|
20
|
79
|
82
|
0
|
0
|
|
Extension 1
STARTED
|
0
|
0
|
0
|
0
|
0
|
241
|
0
|
|
Extension 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
219
|
0
|
|
Extension 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
22
|
0
|
|
Extension 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
|
Extension 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Extension 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Extension 1
This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered \~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
|
Extension 2
This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
|
|---|---|---|---|---|---|---|---|
|
Base Study (Day 1 to Month 7)
Randomized Not Vaccinated
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Adverse Event
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Lost to Follow-up
|
4
|
6
|
6
|
4
|
0
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Pregnancy
|
3
|
2
|
3
|
1
|
1
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Protocol Violation
|
1
|
2
|
0
|
1
|
2
|
0
|
0
|
|
Base Study (Day 1 to Month 7)
Withdrawal by Subject
|
12
|
9
|
12
|
4
|
3
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Proceeded to Extension 1
|
114
|
0
|
0
|
69
|
75
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Lost to Follow-up
|
6
|
8
|
5
|
4
|
3
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Moved
|
3
|
2
|
1
|
2
|
0
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Other
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Protocol Violation
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Long Term Follow-up (Month 7 toMonth 36)
Withdrawal by Subject
|
7
|
4
|
13
|
4
|
3
|
0
|
0
|
|
Extension 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Extension 1
Other
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
|
Extension 1
Moved
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Extension 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Extension 1
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
|
Extension 1
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Extension 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Extension 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Extension 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
Baseline Characteristics
Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
n=290 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
n=284 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
n=292 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
n=146 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
n=146 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Total
n=1158 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.2 years
n=5 Participants
|
20.0 years
n=7 Participants
|
20.1 years
n=5 Participants
|
20.0 years
n=4 Participants
|
20.1 years
n=21 Participants
|
20.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
290 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
292 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
1158 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
34 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
25 participants
n=5 Participants
|
32 participants
n=7 Participants
|
27 participants
n=5 Participants
|
12 participants
n=4 Participants
|
7 participants
n=21 Participants
|
103 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
61 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
39 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
9 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
228 participants
n=5 Participants
|
213 participants
n=7 Participants
|
240 participants
n=5 Participants
|
111 participants
n=4 Participants
|
118 participants
n=21 Participants
|
910 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Days 1-5 following any vaccination visitPopulation: All vaccinated subjects with adverse experience follow-up.
Outcome measures
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
n=288 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
n=282 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
n=292 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
n=146 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
n=146 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
|---|---|---|---|---|---|
|
Number of Subjects With Injection Site Adverse Experiences
|
247 Participants
|
248 Participants
|
266 Participants
|
107 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: Through 36 MonthsPopulation: Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7
Outcome measures
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
n=235 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
n=233 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
|---|---|---|---|---|---|
|
Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)
|
0.7 Incidence per 100 person-years
|
6.7 Incidence per 100 person-years
|
—
|
—
|
—
|
Adverse Events
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
Serious events: 3 serious events
Other events: 245 other events
Deaths: 0 deaths
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
Serious events: 0 serious events
Other events: 247 other events
Deaths: 0 deaths
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
Serious events: 2 serious events
Other events: 263 other events
Deaths: 0 deaths
Placebo (mcg) (Aluminum Adjuvant) 225
Serious events: 0 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo (mcg) (Aluminum Adjuvant) 450
Serious events: 3 serious events
Other events: 114 other events
Deaths: 0 deaths
Extensions
Serious events: 1 serious events
Other events: 180 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
n=288 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
* There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.
* There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
n=282 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
* There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
n=292 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
n=146 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
n=146 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Extensions
n=241 participants at risk
This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered \~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
* Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.68%
1/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Gastrointestinal disorders
Kidney infection
|
0.00%
0/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.68%
1/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Gastrointestinal disorders
Pyelonephritis
|
0.00%
0/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.34%
1/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.41%
1/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.35%
1/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Psychiatric disorders
Depression
|
0.35%
1/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.34%
1/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Renal and urinary disorders
Renal colic
|
0.35%
1/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.68%
1/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
Other adverse events
| Measure |
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
n=288 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
* There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.
* There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
n=282 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
* There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table.
|
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
n=292 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 225
n=146 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Placebo (mcg) (Aluminum Adjuvant) 450
n=146 participants at risk
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.
|
Extensions
n=241 participants at risk
This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered \~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
* Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
13/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.0%
14/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.5%
16/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
3.4%
5/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
10/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.7%
16/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.7%
8/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.8%
7/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.1%
3/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
19/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
8.2%
23/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
7.2%
21/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
8.9%
13/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.8%
10/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Fatigue
|
9.0%
26/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.8%
8/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
7.9%
23/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Pyrexia
|
10.4%
30/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
13.1%
37/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
14.0%
41/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
8.9%
13/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
11.0%
16/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.8%
14/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Injection Site Erythema
|
26.0%
75/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
20.9%
59/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
27.4%
80/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
21.2%
31/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
21.2%
31/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
14.5%
35/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Injection Site Haematoma
|
5.9%
17/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
3.2%
9/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.8%
14/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.5%
8/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.1%
3/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Injection Site Pain
|
85.1%
245/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
87.6%
247/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
90.1%
263/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
71.9%
105/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
78.1%
114/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
74.7%
180/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
General disorders
Injection Site Swelling
|
27.8%
80/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
26.2%
74/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
32.5%
95/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
15.8%
23/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
19.9%
29/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
19.1%
46/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Infections and infestations
Influenza
|
4.5%
13/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.0%
17/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.1%
15/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.8%
7/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
20/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
8.2%
23/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.8%
20/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
11.6%
17/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
12/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
3.5%
10/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.7%
8/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.68%
1/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
9/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.1%
6/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
1.4%
4/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.8%
7/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.2%
9/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Nervous system disorders
Headache
|
40.6%
117/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
36.5%
103/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
39.7%
116/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
50.7%
74/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
36.3%
53/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
24.9%
60/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.5%
10/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
2.8%
8/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.5%
13/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
10.3%
15/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
4.1%
6/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
20/288 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
3.5%
10/282 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
5.8%
17/292 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
7.5%
11/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
6.8%
10/146 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
0.00%
0/241 • Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject's vaccination report card daily for 14 days after each injection.
Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER