Trial Outcomes & Findings for An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020) (NCT NCT00090285)
NCT ID: NCT00090285
Last Updated: 2018-08-23
Results Overview
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4065 participants
Primary outcome timeframe
Base study: through Month 36
Results posted on
2018-08-23
Participant Flow
A total of 4164 participants were screened and 4065 were randomized
Participant milestones
| Measure |
qHPV Vaccine in Base Study
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
EXT1: Placebo in Base Study
Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.
Participants were followed to EXT1 Month 7.
|
EXT1: Incomplete qHPV Regimen in Base Study
Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
Participants were followed to EXT1 Month 7.
|
LTFU (EXT2): Early Vaccination Group
Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
|
LTFU (EXT2): Catch-up Vaccination Group
Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
|
|---|---|---|---|---|---|---|
|
Base Study Vaccination Period
STARTED
|
2032
|
2033
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Vaccinated
|
2025
|
2030
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
COMPLETED
|
1818
|
1814
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
NOT COMPLETED
|
214
|
219
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
STARTED
|
1822
|
1821
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
COMPLETED
|
1487
|
1479
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
NOT COMPLETED
|
335
|
342
|
0
|
0
|
0
|
0
|
|
Extension 1
STARTED
|
0
|
0
|
1098
|
16
|
0
|
0
|
|
Extension 1
COMPLETED
|
0
|
0
|
1041
|
15
|
0
|
0
|
|
Extension 1
NOT COMPLETED
|
0
|
0
|
57
|
1
|
0
|
0
|
|
Long-term Follow-up (EXT2)
STARTED
|
0
|
0
|
0
|
0
|
936
|
867
|
|
Long-term Follow-up (EXT2)
COMPLETED
|
0
|
0
|
0
|
0
|
709
|
664
|
|
Long-term Follow-up (EXT2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
227
|
203
|
Reasons for withdrawal
| Measure |
qHPV Vaccine in Base Study
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received quadrivalent human papillomavirus (qHPV) vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
EXT1: Placebo in Base Study
Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at Extension 1 (EXT1) Day 1, Month 2 and Month 6.
Participants were followed to EXT1 Month 7.
|
EXT1: Incomplete qHPV Regimen in Base Study
Participants who received only 1 dose of qHPV vaccine in the Base Study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the Base Study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
Participants were followed to EXT1 Month 7.
|
LTFU (EXT2): Early Vaccination Group
Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2).
|
LTFU (EXT2): Catch-up Vaccination Group
Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2).
|
|---|---|---|---|---|---|---|
|
Base Study Vaccination Period
Randomized Not Vaccinated
|
7
|
3
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Adverse Event
|
2
|
4
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Lost to Follow-up
|
111
|
112
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Protocol Violation
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Withdrawal by Subject
|
64
|
69
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Uncooperative
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Moved
|
20
|
21
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Site Terminated
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Other
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
Subject Incarcerated
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Base Study Vaccination Period
HIV positive
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Adverse Event
|
3
|
10
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Lost to Follow-up
|
232
|
226
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Withdrawal by Subject
|
53
|
64
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Moved
|
41
|
36
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Other
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Uncooperative
|
3
|
4
|
0
|
0
|
0
|
0
|
|
Base Study Follow-up Period
Subject Incarcerated
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Extension 1
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Extension 1
Lost to Follow-up
|
0
|
0
|
35
|
0
|
0
|
0
|
|
Extension 1
Withdrawal by Subject
|
0
|
0
|
13
|
1
|
0
|
0
|
|
Extension 1
Other
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Extension 1
Moved
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Long-term Follow-up (EXT2)
Adverse Event
|
0
|
0
|
0
|
0
|
5
|
2
|
|
Long-term Follow-up (EXT2)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
156
|
143
|
|
Long-term Follow-up (EXT2)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
60
|
53
|
|
Long-term Follow-up (EXT2)
Physician Decision
|
0
|
0
|
0
|
0
|
6
|
5
|
Baseline Characteristics
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Baseline characteristics by cohort
| Measure |
qHPV Vaccine in Base Study
n=2032 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=2033 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Total
n=4065 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20 Years
n=113 Participants
|
20 Years
n=163 Participants
|
20 Years
n=160 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
2032 Participants
n=113 Participants
|
2033 Participants
n=163 Participants
|
4065 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Asian
|
201 participants
n=113 Participants
|
205 participants
n=163 Participants
|
406 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Black
|
405 participants
n=113 Participants
|
400 participants
n=163 Participants
|
805 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
412 participants
n=113 Participants
|
423 participants
n=163 Participants
|
835 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=113 Participants
|
2 participants
n=163 Participants
|
3 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
White
|
719 participants
n=113 Participants
|
712 participants
n=163 Participants
|
1431 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
291 participants
n=113 Participants
|
283 participants
n=163 Participants
|
574 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Indian (subcontinent)
|
1 participants
n=113 Participants
|
8 participants
n=163 Participants
|
9 participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Polynesian
|
2 participants
n=113 Participants
|
0 participants
n=163 Participants
|
2 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Base study: through Month 36Population: Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=1394 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=1404 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
|
0.1 Incidence per 100 person-years
|
1.0 Incidence per 100 person-years
|
PRIMARY outcome
Timeframe: Up to 10 years after the first dose of qHPV vaccinePopulation: Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.
Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=1243 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Overall Study: Incidence of HPV Type 6/11-related Genital Warts
|
4.3 Incidence per 10,000 person-years
Interval 0.9 to 12.5
|
—
|
PRIMARY outcome
Timeframe: Up to 10 years after the first dose of qHPV vaccinePopulation: Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.
Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=1395 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
|
3.8 Incidence per 10,000 person-years
Interval 0.8 to 11.1
|
—
|
PRIMARY outcome
Timeframe: Up to 10 years after the first dose of qHPV vaccinePopulation: Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to MSM in the Base Study qHPV vaccine group.
Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=194 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
|
69.3 Incidence per 10,000 person-years
Interval 25.4 to 150.8
|
—
|
PRIMARY outcome
Timeframe: Base study: through Day 5 after any vaccinationPopulation: The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2020 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=2029 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
|
25 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Base study: through Month 36Population: The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.
A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2020 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=2029 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccinePopulation: The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).
An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=936 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=867 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccinePopulation: The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).
The number of participants who died was assessed.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=936 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=867 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
LTFU (EXT2): Number of Participants Who Died
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Base study: through Month 36Population: Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=1390 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=1402 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
|
0.7 Infection per 100 person-years
|
4.8 Infection per 100 person-years
|
SECONDARY outcome
Timeframe: Base study: through Month 36Population: Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=1390 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=1402 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
|
5.3 Detection per 100 person-years
|
10.7 Detection per 100 person-years
|
SECONDARY outcome
Timeframe: Month 7Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
HPV Type 6
|
447.7 cLIA mMU/mL
Interval 415.9 to 481.9
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
HPV Type 11
|
624.4 cLIA mMU/mL
Interval 588.4 to 662.6
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
HPV Type 16
|
2406.1 cLIA mMU/mL
Interval 2245.0 to 2578.8
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
HPV Type 18
|
402.8 cLIA mMU/mL
Interval 373.9 to 433.9
|
—
|
SECONDARY outcome
Timeframe: Month 36Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 6
|
71.5 cLIA mMU/mL
Interval 66.7 to 76.7
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 11
|
82.5 cLIA mMU/mL
Interval 77.0 to 88.5
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 16
|
293.6 cLIA mMU/mL
Interval 271.6 to 317.4
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 18
|
33.2 cLIA mMU/mL
Interval 30.2 to 36.4
|
—
|
SECONDARY outcome
Timeframe: Month 72Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 18
|
25.9 cLIA mMU/mL
Interval 23.2 to 28.9
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 6
|
57.2 cLIA mMU/mL
Interval 52.3 to 62.5
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 11
|
62.1 cLIA mMU/mL
Interval 56.7 to 68.1
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 16
|
249.4 cLIA mMU/mL
Interval 225.6 to 275.8
|
—
|
SECONDARY outcome
Timeframe: Month 120Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 6
|
49.4 cLIA mMU/mL
Interval 44.1 to 55.4
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 11
|
38.7 cLIA mMU/mL
Interval 34.5 to 43.5
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 16
|
182.9 cLIA mMU/mL
Interval 161.4 to 207.3
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 18
|
17.6 cLIA mMU/mL
Interval 15.5 to 19.9
|
—
|
SECONDARY outcome
Timeframe: Month 7Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
HPV Type 16
|
98.8 Percentage of participants
Interval 97.9 to 99.3
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
HPV Type 18
|
97.4 Percentage of participants
Interval 96.3 to 98.2
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
HPV Type 6
|
98.9 Percentage of participants
Interval 98.1 to 99.4
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
HPV Type 11
|
99.2 Percentage of participants
Interval 98.4 to 99.6
|
—
|
SECONDARY outcome
Timeframe: Month 36Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 18
|
57.1 Percentage of participants
Interval 53.8 to 60.3
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 6
|
88.9 Percentage of participants
Interval 86.6 to 90.9
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 11
|
94.0 Percentage of participants
Interval 92.1 to 95.5
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
HPV Type 16
|
97.9 Percentage of participants
Interval 96.8 to 98.8
|
—
|
SECONDARY outcome
Timeframe: Month 72Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 6
|
84.3 Percentage of participants
Interval 81.1 to 87.2
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 11
|
88.0 Percentage of participants
Interval 85.1 to 90.5
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 16
|
97.0 Percentage of participants
Interval 95.4 to 98.2
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
HPV Type 18
|
49.6 Percentage of participants
Interval 45.6 to 53.6
|
—
|
SECONDARY outcome
Timeframe: Month 120Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 18
|
40.2 Percentage of participants
Interval 35.4 to 45.1
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 6
|
79.1 Percentage of participants
Interval 74.7 to 83.2
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 11
|
79.9 Percentage of participants
Interval 75.5 to 83.9
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
HPV Type 16
|
94.9 Percentage of participants
Interval 92.2 to 96.9
|
—
|
SECONDARY outcome
Timeframe: Month 120Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study.
Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
HPV Type 6
|
38.8 IgG LIA mMU/mL
Interval 34.0 to 44.2
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
HPV Type 11
|
31.0 IgG LIA mMU/mL
Interval 27.2 to 35.3
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
HPV Type 16
|
162.0 IgG LIA mMU/mL
Interval 141.2 to 185.7
|
—
|
|
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
HPV Type 18
|
19.7 IgG LIA mMU/mL
Interval 17.0 to 22.9
|
—
|
SECONDARY outcome
Timeframe: Month 120Population: All participants who 1) were seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, 2) received all 3 vaccinations, and 3) did not have protocol deviations that could interfere with the effects of the vaccine. Immunogenicity was assessed only for participants who received qHPV vaccine in the Base Study..
Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=2025 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
HPV Type 6
|
91.7 Percentage of participants
Interval 87.8 to 94.7
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
HPV Type 11
|
92.0 Percentage of participants
Interval 88.1 to 94.9
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
HPV Type 16
|
99.7 Percentage of participants
Interval 98.1 to 100.0
|
—
|
|
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
HPV Type 18
|
92.1 Percentage of participants
Interval 88.5 to 94.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Base study: through Month 36Population: Only a subset of participants was included for this sub-study. Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.
Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up was assessed.
Outcome measures
| Measure |
qHPV Vaccine in Base Study
n=194 Participants
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
Placebo in Base Study
n=208 Participants
The Vaccination Period for the Base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
Follow-up for the Base Study encompassed Month 7 through Month 36.
|
|---|---|---|
|
Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)
|
1.3 Incidence per 100 person-years
|
5.8 Incidence per 100 person-years
|
Adverse Events
qHPV Vaccine: Base Study
Serious events: 8 serious events
Other events: 1277 other events
Deaths: 3 deaths
Placebo: Base Study
Serious events: 11 serious events
Other events: 1183 other events
Deaths: 10 deaths
qHPV Vaccine: EXT1
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
LTFU (EXT2)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
qHPV Vaccine: Base Study
n=2020 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
|
Placebo: Base Study
n=2029 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
|
qHPV Vaccine: EXT1
n=1084 participants at risk
Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
|
LTFU (EXT2)
n=1803 participants at risk
Participants received ≥1 dose of qHPV vaccine in Base Study, or received placebo in Base Study and qHPV vaccine in EXT1. This arm includes both groups enrolled in LTFU (EXT2): Early Vaccination Group and Catch-up Vaccination Group.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Non-cardiac chest pain
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Appendicitis
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Cellulitis
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Varicella
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.09%
1/1084 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.15%
3/2029 • Number of events 3 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.09%
1/1084 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.05%
1/2029 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Nervous system disorders
Convulsion
|
0.05%
1/2020 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.10%
2/2029 • Number of events 2 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1803 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.09%
1/1084 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
HIV infection
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Blast injury
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/2020 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/2029 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.00%
0/1084 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.06%
1/1803 • Number of events 1 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
Other adverse events
| Measure |
qHPV Vaccine: Base Study
n=2020 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.
|
Placebo: Base Study
n=2029 participants at risk
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.
|
qHPV Vaccine: EXT1
n=1084 participants at risk
Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1).
|
LTFU (EXT2)
n=1803 participants at risk
Participants received ≥1 dose of qHPV vaccine in Base Study, or received placebo in Base Study and qHPV vaccine in EXT1. This arm includes both groups enrolled in LTFU (EXT2): Early Vaccination Group and Catch-up Vaccination Group.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.94%
19/2020 • Number of events 21 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
1.1%
23/2029 • Number of events 23 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
40/2020 • Number of events 44 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
1.8%
36/2029 • Number of events 38 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Gastrointestinal disorders
Nausea
|
1.3%
27/2020 • Number of events 30 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.79%
16/2029 • Number of events 16 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Pyrexia
|
5.8%
118/2020 • Number of events 131 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
6.2%
125/2029 • Number of events 149 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Injection Site Erythema
|
15.0%
304/2020 • Number of events 446 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
13.6%
275/2029 • Number of events 384 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Injection Site Pain
|
55.2%
1116/2020 • Number of events 2087 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
48.9%
992/2029 • Number of events 1767 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Injection Site Pruritus
|
1.1%
23/2020 • Number of events 27 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
1.2%
24/2029 • Number of events 29 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
General disorders
Injection Site Swelling
|
10.8%
219/2020 • Number of events 318 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
9.2%
187/2029 • Number of events 270 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Influenza
|
2.1%
42/2020 • Number of events 43 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
2.2%
44/2029 • Number of events 47 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
44/2020 • Number of events 46 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
2.5%
50/2029 • Number of events 59 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Pharyngitis
|
1.1%
22/2020 • Number of events 23 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.99%
20/2029 • Number of events 21 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
27/2020 • Number of events 28 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
0.99%
20/2029 • Number of events 22 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Nervous system disorders
Headache
|
8.9%
179/2020 • Number of events 222 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
10.2%
207/2029 • Number of events 275 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
38/2020 • Number of events 38 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
1.8%
37/2029 • Number of events 37 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
|
—
0/0 • Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.
Medical Dictionary for Regulatory Activities (MedDRA) version 12.0 was used during the base study and follow-up, MedDRA version 14.1 was used during EXT1, and MedDRA version 20.0 was used during LTFU (EXT2). Participants at risk in EXT1 received ≥1 qHPV vaccination in EXT1 and had follow-up data. Other AEs were not solicited during EXT1 or LTFU (EXT2).
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Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER