Trial Outcomes & Findings for Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) (NCT NCT00092521)
NCT ID: NCT00092521
Last Updated: 2015-09-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5759 participants
Primary outcome timeframe
Follow-up through end of study (4 years)
Results posted on
2015-09-25
Participant Flow
The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.
Participant milestones
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.
|
Group 3 - Base Study Placebo
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|
|
Vaccination (Day 1 Through Month 7)
STARTED
|
2723
|
304
|
2732
|
0
|
|
Vaccination (Day 1 Through Month 7)
COMPLETED
|
2583
|
290
|
2586
|
0
|
|
Vaccination (Day 1 Through Month 7)
NOT COMPLETED
|
140
|
14
|
146
|
0
|
|
Follow-Up (After Month 7)
STARTED
|
2599
|
291
|
2607
|
0
|
|
Follow-Up (After Month 7)
COMPLETED
|
2353
|
155
|
1959
|
0
|
|
Follow-Up (After Month 7)
NOT COMPLETED
|
246
|
136
|
648
|
0
|
|
Extension Study (Group 4)
STARTED
|
0
|
0
|
0
|
844
|
|
Extension Study (Group 4)
Initiated Extension Study
|
0
|
0
|
0
|
829
|
|
Extension Study (Group 4)
Received >=1 Dose in Extension Study
|
0
|
0
|
0
|
801
|
|
Extension Study (Group 4)
COMPLETED
|
0
|
0
|
0
|
635
|
|
Extension Study (Group 4)
NOT COMPLETED
|
0
|
0
|
0
|
209
|
Reasons for withdrawal
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.
|
Group 3 - Base Study Placebo
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|
|
Vaccination (Day 1 Through Month 7)
Randomized Not Vaccinated
|
6
|
0
|
7
|
0
|
|
Vaccination (Day 1 Through Month 7)
Adverse Event
|
1
|
0
|
7
|
0
|
|
Vaccination (Day 1 Through Month 7)
Death
|
0
|
0
|
1
|
0
|
|
Vaccination (Day 1 Through Month 7)
Lost to Follow-up
|
51
|
6
|
44
|
0
|
|
Vaccination (Day 1 Through Month 7)
Pregnancy
|
5
|
0
|
7
|
0
|
|
Vaccination (Day 1 Through Month 7)
Withdrawal by Subject
|
59
|
7
|
62
|
0
|
|
Vaccination (Day 1 Through Month 7)
Moved
|
14
|
1
|
18
|
0
|
|
Vaccination (Day 1 Through Month 7)
Unblinded
|
2
|
0
|
0
|
0
|
|
Vaccination (Day 1 Through Month 7)
New Medical History (Not AE)
|
2
|
0
|
0
|
0
|
|
Follow-Up (After Month 7)
Subjects Continuing
|
34
|
4
|
35
|
0
|
|
Follow-Up (After Month 7)
Subjects in Extension
|
13
|
109
|
412
|
0
|
|
Follow-Up (After Month 7)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Follow-Up (After Month 7)
Death
|
2
|
0
|
1
|
0
|
|
Follow-Up (After Month 7)
Lost to Follow-up
|
113
|
14
|
108
|
0
|
|
Follow-Up (After Month 7)
Protocol Violation
|
1
|
1
|
5
|
0
|
|
Follow-Up (After Month 7)
Withdrawal by Subject
|
40
|
6
|
51
|
0
|
|
Follow-Up (After Month 7)
Moved
|
32
|
2
|
28
|
0
|
|
Follow-Up (After Month 7)
Site Terminated
|
3
|
0
|
3
|
0
|
|
Follow-Up (After Month 7)
Travel
|
2
|
0
|
0
|
0
|
|
Follow-Up (After Month 7)
Visits Compressed
|
5
|
0
|
5
|
0
|
|
Extension Study (Group 4)
Excluded ineligible for extension
|
0
|
0
|
0
|
23
|
|
Extension Study (Group 4)
Adverse Event
|
0
|
0
|
0
|
2
|
|
Extension Study (Group 4)
Lost to Follow-up
|
0
|
0
|
0
|
87
|
|
Extension Study (Group 4)
Pregnancy
|
0
|
0
|
0
|
4
|
|
Extension Study (Group 4)
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Extension Study (Group 4)
Withdrawal by Subject
|
0
|
0
|
0
|
46
|
|
Extension Study (Group 4)
Moved
|
0
|
0
|
0
|
16
|
|
Extension Study (Group 4)
Site Terminated
|
0
|
0
|
0
|
4
|
|
Extension Study (Group 4)
Unable/unwilling to return
|
0
|
0
|
0
|
25
|
Baseline Characteristics
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
n=2723 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
n=304 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 3 - Base Study Placebo
n=2732 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Total
n=5759 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20 Years
n=5 Participants
|
20 Years
n=7 Participants
|
20 Years
n=5 Participants
|
20 Years
n=4 Participants
|
|
Age, Customized
16 to 24 Years of Age
|
2723 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
2732 Participants
n=5 Participants
|
5759 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2723 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
2732 Participants
n=5 Participants
|
5759 Participants
n=4 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
|
|
Race/Ethnicity, Customized
Asian
|
151 participants
n=5 Participants
|
27 participants
n=7 Participants
|
165 participants
n=5 Participants
|
343 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
136 participants
n=5 Participants
|
5 participants
n=7 Participants
|
167 participants
n=5 Participants
|
308 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
567 participants
n=5 Participants
|
93 participants
n=7 Participants
|
566 participants
n=5 Participants
|
1226 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
10 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1600 participants
n=5 Participants
|
171 participants
n=7 Participants
|
1558 participants
n=5 Participants
|
3329 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other - Unspecified
|
259 participants
n=5 Participants
|
6 participants
n=7 Participants
|
266 participants
n=5 Participants
|
531 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Follow-up through end of study (4 years)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.
Outcome measures
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
n=2241 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 3 - Base Study Placebo
n=2258 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
|
0 incidence rate per 100 person-years
|
1.2 incidence rate per 100 person-years
|
PRIMARY outcome
Timeframe: Follow-up through end of study (4 years)Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.
Outcome measures
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
n=2261 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 3 - Base Study Placebo
n=2279 Participants
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
|---|---|---|
|
Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]
|
0 incidence rate per 100 person-years
|
1.1 incidence rate per 100 person-years
|
Adverse Events
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
Serious events: 50 serious events
Other events: 2458 other events
Deaths: 0 deaths
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
Serious events: 4 serious events
Other events: 276 other events
Deaths: 0 deaths
Group 3 - Base Study Placebo
Serious events: 45 serious events
Other events: 2331 other events
Deaths: 0 deaths
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
n=2673 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
n=299 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 3 - Base Study Placebo
n=2672 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
n=801 participants at risk
This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.12%
1/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.12%
1/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Anogenital warts
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Appendicitis
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.33%
1/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Endometritis decidual
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.33%
1/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.12%
1/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.12%
1/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Post procedural infection
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Varicella
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.60%
16/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.67%
2/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.79%
21/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.11%
3/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Headache
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.12%
1/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Cervix dystocia
|
0.15%
4/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction of labor
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Failed trial of labor
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal distress syndrome
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal malposition
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.11%
3/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labor
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labor
|
0.07%
2/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Pregnancy, puerperium and perinatal conditions
Transverse presentation
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Psychiatric disorders
Completed suicide
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.04%
1/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Vascular disorders
Hypotension
|
0.04%
1/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/801
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
Other adverse events
| Measure |
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
n=2673 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
n=299 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 3 - Base Study Placebo
n=2672 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.
The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
|
Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
n=801 participants at risk
This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent \[type 16\] HPV vaccine in the base study, or subjects who received \<=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
88/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.7%
8/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
81/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
82/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.7%
5/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.3%
87/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
105/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
9/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.6%
96/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.64%
17/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.7%
5/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.60%
16/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Gastritis
|
0.82%
22/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.3%
4/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.49%
13/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Nausea
|
7.9%
210/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
7.7%
23/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
6.5%
174/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Toothache
|
1.8%
48/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.3%
4/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.5%
40/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
62/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
9/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.1%
56/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Asthenia
|
1.1%
29/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.3%
7/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.94%
25/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Fatigue
|
2.7%
73/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.0%
12/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.8%
102/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Malaise
|
1.8%
47/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.5%
40/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Pain
|
0.71%
19/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.97%
26/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Pyrexia
|
16.3%
436/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
11.0%
33/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
13.0%
348/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.64%
17/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.67%
18/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Influenza
|
4.6%
124/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
6.0%
18/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.2%
113/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
185/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
7.4%
22/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
6.2%
166/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Pharyngitis
|
1.2%
32/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.2%
31/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Sinusitis
|
0.82%
22/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.67%
18/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Tonsillitis
|
0.97%
26/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.67%
2/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.1%
29/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
36/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
9/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.6%
42/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.37%
10/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.3%
4/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.60%
16/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.15%
4/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.15%
4/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
27/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.94%
25/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.5%
68/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.3%
10/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.4%
63/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.52%
14/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.45%
12/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
49/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.0%
6/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.0%
54/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.1%
55/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.3%
7/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.1%
57/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Dizziness
|
4.6%
123/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
6.0%
18/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.3%
114/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Headache
|
30.0%
802/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
34.4%
103/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.8%
76/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Migraine
|
0.86%
23/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.56%
15/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Nervous system disorders
Somnolence
|
1.1%
30/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.00%
0/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.2%
32/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Psychiatric disorders
Insomnia
|
1.3%
35/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.67%
2/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.86%
23/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
4.0%
106/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.7%
11/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.7%
100/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.52%
14/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.3%
4/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.82%
22/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
59/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.0%
6/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.5%
40/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.97%
26/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.56%
15/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.1%
109/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.7%
14/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.3%
116/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.19%
5/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.0%
3/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.37%
10/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site erythema
|
24.7%
659/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
28.1%
84/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
16.8%
450/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site haematoma
|
3.5%
94/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
2.0%
6/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.6%
97/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site hypersensitivity
|
1.0%
27/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
9/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.82%
22/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site pain
|
85.3%
2281/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
80.9%
242/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
75.4%
2014/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site pruritus
|
4.1%
109/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
4.0%
12/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
3.0%
80/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site reaction
|
0.82%
22/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
1.3%
4/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
0.64%
17/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
|
General disorders
Injection site swelling
|
26.0%
694/2673
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
23.4%
70/299
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
15.5%
413/2672
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
—
0/0
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received \>=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
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