Trial Outcomes & Findings for Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041) (NCT NCT00834106)
NCT ID: NCT00834106
Last Updated: 2019-02-04
Results Overview
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3006 participants
Primary outcome timeframe
From Day 1 until >=25 cases accumulate, up to Month 30
Results posted on
2019-02-04
Participant Flow
Participants were stratified by age before randomization: 20 to 26 years of age and 27 to 45 years of age.
Participant milestones
| Measure |
qHPV
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study (Day 1 to Month 30)
STARTED
|
1503
|
1503
|
|
Base Study (Day 1 to Month 30)
Vaccinated
|
1503
|
1503
|
|
Base Study (Day 1 to Month 30)
Completed Vaccinations
|
1473
|
1463
|
|
Base Study (Day 1 to Month 30)
COMPLETED
|
1401
|
1358
|
|
Base Study (Day 1 to Month 30)
NOT COMPLETED
|
102
|
145
|
|
Extension Study (Month 42 to Month 90)
STARTED
|
1404
|
1368
|
|
Extension Study (Month 42 to Month 90)
COMPLETED
|
1308
|
1294
|
|
Extension Study (Month 42 to Month 90)
NOT COMPLETED
|
96
|
74
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
Baseline characteristics by cohort
| Measure |
qHPV
n=1503 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1503 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Total
n=3006 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.7 Years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
28.7 Years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
28.7 Years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Age, Customized
20 to 26 years of age
|
923 Participants
n=99 Participants
|
917 Participants
n=107 Participants
|
1840 Participants
n=206 Participants
|
|
Age, Customized
27 to 45 years of age
|
580 Participants
n=99 Participants
|
586 Participants
n=107 Participants
|
1166 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1503 Participants
n=99 Participants
|
1503 Participants
n=107 Participants
|
3006 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1503 Participants
n=99 Participants
|
1503 Participants
n=107 Participants
|
3006 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Day 1 until >=25 cases accumulate, up to Month 30Population: The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.
Outcome measures
| Measure |
qHPV
n=2491 person-years
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=2389 person-years
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)
|
0.3 Cases per 100 person-years of follow-up
|
1.2 Cases per 100 person-years of follow-up
|
PRIMARY outcome
Timeframe: From Day 1 until >=17 cases accumulate, up to Month 30Population: The population analyzed included participants 20 to 26 years old at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Outcome measures
| Measure |
qHPV
n=1461 person-years
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1376 person-years
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)
|
0.2 Cases per 100 person-years of follow-up
|
1.2 Cases per 100 person-years of follow-up
|
PRIMARY outcome
Timeframe: Up to Month 78Population: The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 16 and 18.
The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.
Outcome measures
| Measure |
qHPV
n=6992 person-years
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=6789 person-years
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)
|
0.0 Cases per 100 person-years of follow-up
|
0.1 Cases per 100 person-years of follow-up
|
PRIMARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: All vaccinated participants with safety follow-up
An adverse event (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 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 AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.
Outcome measures
| Measure |
qHPV
n=1499 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events
|
37.6 Percentage of participants
|
27.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: All vaccinated participants with safety follow-up
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 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 AE.
Outcome measures
| Measure |
qHPV
n=1499 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study: Percentage of Participants With One or More Systemic Adverse Events
|
50.4 Percentage of participants
|
48.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All vaccinated participants with safety follow-up
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 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 AE.
Outcome measures
| Measure |
qHPV
n=1499 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event
|
0.1 Percentage of participants
|
0.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 90 monthsPopulation: All vaccinated participants with safety follow-up
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.
Outcome measures
| Measure |
qHPV
n=1499 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to approximately 90 monthsPopulation: All vaccinated participants with safety follow-up
The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm
Outcome measures
| Measure |
qHPV
n=1499 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 Participants
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Entire Study: Percentage of Participants Who Died
|
0.1 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 78 monthsPopulation: The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.
The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Outcome measures
| Measure |
qHPV
n=8515 person-years
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=8015 person-years
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)
|
0.1 Cases per 100 person-years of follow-up
|
0.7 Cases per 100 person-years of follow-up
|
SECONDARY outcome
Timeframe: Up to 78 monthsPopulation: The population analyzed included participants 20 to 26 years of age at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.
The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Outcome measures
| Measure |
qHPV
n=4952 person-years
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=4559 person-years
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)
|
0.0 Cases per 100 person-years of follow-up
|
0.6 Cases per 100 person-years of follow-up
|
Adverse Events
qHPV
Serious events: 38 serious events
Other events: 876 other events
Deaths: 0 deaths
Placebo
Serious events: 43 serious events
Other events: 799 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
qHPV
n=1499 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 participants at risk
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Endocrine disorders
Thyroid Mass
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Pyrexia
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.13%
2/1498 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Hydatidiform Mole
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Fibroma
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.13%
2/1498 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma Of Breast
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Papilloma Of Breast
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Stage Iii
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Germ Cell Teratoma
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.13%
2/1498 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes Tumour
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.07%
1/1499 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.47%
7/1498 • Number of events 7 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal Cancer Stage 0
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-Pelvic Disproportion
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
|
0.13%
2/1499 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.20%
3/1498 • Number of events 3 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Damage
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Death
|
0.13%
2/1499 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Hypertension
|
0.27%
4/1499 • Number of events 4 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Pregnancy, puerperium and perinatal conditions
Placenta Accreta
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Psychiatric disorders
Depression
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Renal and urinary disorders
Urethral Cyst
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.13%
2/1499 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.13%
2/1498 • Number of events 2 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.20%
3/1498 • Number of events 3 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Fallopian Tube Cyst
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Pelvic Fluid Collection
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Uterine Disorder
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic Cyst
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Appendicectomy
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Ectopic Pregnancy Termination
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Fallopian Tube Operation
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Haemorrhoid Operation
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Hysterectomy
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Labour Induction
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
0/1499 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Synovial Cyst Removal
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Thyroid Adenoma Removal
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.00%
0/1498 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Thyroid Nodule Removal
|
0.07%
1/1499 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.07%
1/1498 • Number of events 1 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Surgical and medical procedures
Uterine Polypectomy
|
0.20%
3/1499 • Number of events 4 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
0.20%
3/1498 • Number of events 3 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
Other adverse events
| Measure |
qHPV
n=1499 participants at risk
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
|
Placebo
n=1498 participants at risk
Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
100/1499 • Number of events 122 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
6.3%
95/1498 • Number of events 106 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
89/1499 • Number of events 106 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
6.3%
94/1498 • Number of events 105 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Fatigue
|
15.1%
227/1499 • Number of events 310 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
12.9%
193/1498 • Number of events 247 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Injection Site Erythema
|
11.7%
176/1499 • Number of events 233 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
8.9%
133/1498 • Number of events 163 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Injection Site Induration
|
7.7%
115/1499 • Number of events 151 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
4.3%
64/1498 • Number of events 76 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Injection Site Pain
|
33.0%
494/1499 • Number of events 778 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
23.1%
346/1498 • Number of events 450 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Injection Site Pruritus
|
7.5%
113/1499 • Number of events 145 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
5.1%
77/1498 • Number of events 83 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Injection Site Swelling
|
10.7%
160/1499 • Number of events 220 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
5.2%
78/1498 • Number of events 92 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
General disorders
Pyrexia
|
25.9%
388/1499 • Number of events 493 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
23.5%
352/1498 • Number of events 432 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.9%
224/1499 • Number of events 307 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
10.2%
153/1498 • Number of events 185 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Nervous system disorders
Headache
|
14.5%
218/1499 • Number of events 274 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
12.9%
193/1498 • Number of events 240 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
84/1499 • Number of events 103 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
6.1%
91/1498 • Number of events 99 • Up to approximately 90 months
All vaccinated participants with safety follow-up
|
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.
- Publication restrictions are in place
Restriction type: OTHER