Trial Outcomes & Findings for A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) (NCT NCT01047345)
NCT ID: NCT01047345
Last Updated: 2018-11-27
Results Overview
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
924 participants
Primary outcome timeframe
up to 5 days after any vaccination - Base Study
Results posted on
2018-11-27
Participant Flow
Participant milestones
| Measure |
9vHPV Vaccine - Base Study
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
9vHPV Vaccine - Extension Study
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
|
|---|---|---|---|
|
Base Study
STARTED
|
618
|
306
|
0
|
|
Base Study
Vaccination 1
|
615
|
306
|
0
|
|
Base Study
Vaccination 2
|
604
|
304
|
0
|
|
Base Study
Vaccination 3
|
597
|
300
|
0
|
|
Base Study
COMPLETED
|
596
|
300
|
0
|
|
Base Study
NOT COMPLETED
|
22
|
6
|
0
|
|
Extension
STARTED
|
0
|
0
|
102
|
|
Extension
Vaccination 4
|
0
|
0
|
102
|
|
Extension
Vaccination 5
|
0
|
0
|
99
|
|
Extension
Vaccination 6
|
0
|
0
|
95
|
|
Extension
COMPLETED
|
0
|
0
|
96
|
|
Extension
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
9vHPV Vaccine - Base Study
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
9vHPV Vaccine - Extension Study
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
|
|---|---|---|---|
|
Base Study
Adverse Event
|
3
|
0
|
0
|
|
Base Study
Lost to Follow-up
|
4
|
1
|
0
|
|
Base Study
Protocol Violation
|
3
|
1
|
0
|
|
Base Study
Withdrawal by Subject
|
12
|
4
|
0
|
|
Extension
Withdrawal by Subject
|
0
|
0
|
1
|
|
Extension
Lost to Follow-up
|
0
|
0
|
5
|
Baseline Characteristics
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
Baseline characteristics by cohort
| Measure |
9vHPV Vaccine - Base Study
n=618 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=306 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
Total
n=924 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12 to 15 years
|
122 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Age, Customized
16 to 26 years
|
496 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
618 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
924 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 days after any vaccination - Base StudyPopulation: All participants who received at least 1 vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=608 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
|
91.1 Percentage of Participants
|
43.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 5 days after any vaccination - Base StudyPopulation: All participants who received at least 1 vaccination and had available temperature data.
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=604 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=304 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
|
6.5 Percentage of Participants
|
3.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 14 days after any vaccination - Base StudyPopulation: All participants who received at least 1 vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=608 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience a Systemic AE - Base Study
|
59.7 Percentage of Participants
|
55.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 14 days after any vaccination - Base StudyPopulation: All participants who received at least 1 vaccination and had available follow-up data.
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=608 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study
|
0.3 Percentage of Participants
|
0.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 7 months - Base StudyPopulation: All participants who received at least 1 vaccination and had available follow-up data.
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" is defined as a vaccine-related SAE.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=608 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study
|
0.2 Percentage of Participants
|
0.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 5 days after any vaccination - Base StudyPopulation: All participants who received at least 1 vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=608 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
|
11.2 Percentage of Participants
|
1.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7; End of Base Study)Population: Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=515 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=261 Participants
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 6 (n=511; n=251)
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 98.5 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 11 (n=515; n=261)
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 16 (n=515; n=261)
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 18 (n=515; n=261)
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
85.4 Percentage of Participants
Interval 80.6 to 89.5
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 31 (n=515; n=261)
|
99.8 Percentage of Participants
Interval 98.9 to 100.0
|
23.8 Percentage of Participants
Interval 18.7 to 29.4
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 33 (n=515; n=261)
|
99.8 Percentage of Participants
Interval 98.9 to 100.0
|
8.0 Percentage of Participants
Interval 5.0 to 12.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 45 (n=515; n=261)
|
98.3 Percentage of Participants
Interval 96.7 to 99.2
|
3.4 Percentage of Participants
Interval 1.6 to 6.4
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 52 (n=515; n=261)
|
99.6 Percentage of Participants
Interval 98.6 to 100.0
|
3.8 Percentage of Participants
Interval 1.9 to 6.9
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Anti-HPV 58 (n=515; n=261)
|
99.8 Percentage of Participants
Interval 98.9 to 100.0
|
9.2 Percentage of Participants
Interval 6.0 to 13.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to Month 7 - Extension StudyPopulation: All participants who received at least 1 vaccination in Extension Study and had available follow-up data.
An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
Outcome measures
| Measure |
9vHPV Vaccine - Base Study
n=99 Participants
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
|---|---|---|
|
Percentage of Participants Who Experience an SAE- Extension Study
|
2.0 Percentage of Participants
|
—
|
Adverse Events
9vHPV Vaccine - Base Study
Serious events: 3 serious events
Other events: 566 other events
Deaths: 0 deaths
Placebo - Base Study
Serious events: 3 serious events
Other events: 197 other events
Deaths: 0 deaths
9vHPV Vaccine - Extension Study
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
9vHPV Vaccine - Base Study
n=608 participants at risk
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 participants at risk
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
9vHPV Vaccine - Extension Study
n=99 participants at risk
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.16%
1/608 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/305 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Infections and infestations
Tonsillitis
|
0.16%
1/608 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/305 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.33%
1/305 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.33%
1/305 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Nervous system disorders
Migraine
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.33%
1/305 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Nervous system disorders
Syncope
|
0.16%
1/608 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/305 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.33%
1/305 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/305 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
1.0%
1/99 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/608 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/305 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
1.0%
1/99 • Number of events 1 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
Other adverse events
| Measure |
9vHPV Vaccine - Base Study
n=608 participants at risk
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
|
Placebo - Base Study
n=305 participants at risk
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
|
9vHPV Vaccine - Extension Study
n=99 participants at risk
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.6%
52/608 • Number of events 67 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
3.9%
12/305 • Number of events 13 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
General disorders
Injection site erythema
|
42.4%
258/608 • Number of events 420 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
8.5%
26/305 • Number of events 33 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
General disorders
Injection site pain
|
90.3%
549/608 • Number of events 1392 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
38.4%
117/305 • Number of events 182 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
General disorders
Injection site pruritus
|
7.9%
48/608 • Number of events 68 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
1.3%
4/305 • Number of events 5 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
General disorders
Injection site swelling
|
49.0%
298/608 • Number of events 558 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
5.9%
18/305 • Number of events 27 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
General disorders
Pyrexia
|
6.9%
42/608 • Number of events 50 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
3.3%
10/305 • Number of events 10 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
47/608 • Number of events 55 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
6.2%
19/305 • Number of events 20 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Nervous system disorders
Dizziness
|
5.1%
31/608 • Number of events 34 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
2.0%
6/305 • Number of events 8 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Nervous system disorders
Headache
|
31.2%
190/608 • Number of events 318 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
26.6%
81/305 • Number of events 150 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
40/608 • Number of events 46 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
3.9%
12/305 • Number of events 14 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
0.00%
0/99 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER