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Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil)(V501-015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00092534
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : November 26, 2009
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Cervical Cancer
Genital Warts
Interventions Biological: Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
Biological: Matching Placebo
Enrollment 12167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Extension Study
Hide Arm/Group Description

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as "Completed Period" are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
Period Title: Base Study Vaccination Period
Started 6087 6080 0
Completed 5916 5954 0
Not Completed 171 126 0
Reason Not Completed
Randomized not Vaccinated             5             5             0
Adverse Event             3             1             0
Death             5             4             0
Lost to Follow-up             41             37             0
Physician Decision             1             0             0
Pregnancy             9             7             0
Protocol Violation             2             1             0
Withdrawal by Subject             85             58             0
Moved             14             12             0
New Medical History (Not AEs)             5             0             0
Travel             1             0             0
Site Closed             0             1             0
Period Title: Base Study Follow Up Period
Started 5942 [1] 5971 [1] 0
Completed 5626 5277 0
Not Completed 316 694 0
Reason Not Completed
Adverse Event             2             4             0
Death             2             1             0
Lost to Follow-up             120             146             0
Pregnancy             6             10             0
Protocol Violation             1             2             0
Withdrawal by Subject             71             62             0
Moved             62             58             0
Travel             10             7             0
Site Closed             0             2             0
Subjects continuing             27             31             0
Subjects in extension             15             371             0
[1]
Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up.
Period Title: Extension Study
Started 0 0 594
Completed 0 0 449
Not Completed 0 0 145
Reason Not Completed
Lost to Follow-up             0             0             41
Physician Decision             0             0             1
Pregnancy             0             0             12
Withdrawal by Subject             0             0             18
Moved             0             0             6
Travel             0             0             2
Site Closed             0             0             21
Study Ended             0             0             29
Protocol Deviation             0             0             15
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Total
Hide Arm/Group Description

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Total of all reporting groups
Overall Number of Baseline Participants 6087 6080 12167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6087 participants 6080 participants 12167 participants
20.0  (2.2) 19.9  (2.1) 19.9  (2.1)
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Between 15 and 26 years Number Analyzed 6087 participants 6080 participants 12167 participants
6087 6080 12167
[1]
Measure Description: Age for study subjects was recorded at the time of subject entry into the base study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6087 participants 6080 participants 12167 participants
Female
6087
 100.0%
6080
 100.0%
12167
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6087 participants 6080 participants 12167 participants
Asian 151 135 286
Black 171 227 398
Hispanic American 555 557 1112
Native American 1 1 2
White 4584 4550 9134
Other-Unspecified 625 610 1235
[1]
Measure Description: Subject race was determined at subject entry into the base study.
1.Primary Outcome
Title Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type
Hide Description

Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up.

The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective.

Time Frame Follow-up through end of study (4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase chain reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data.
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2)
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Overall Number of Participants Analyzed 5306 5262
Measure Type: Number
Unit of Measure: Incidence per 100 person-years
0.0 0.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quadrivalent Human Papillomavirus Vaccine (Group 1), Placebo (Group 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent relative risk reduction
Estimated Value 96.6
Confidence Interval 95%
88.2 to 99.6
Estimation Comments Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter
2.Secondary Outcome
Title Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL
Hide Description Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL
Time Frame Week 4 Postdose 3 (4 weeks after 3rd vaccine dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2)
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Overall Number of Participants Analyzed 1056 1057
Measure Type: Number
Unit of Measure: Participants
1054 13
3.Secondary Outcome
Title Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL
Hide Description Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL
Time Frame Week 4 Postdose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2)
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Overall Number of Participants Analyzed 1057 1057
Measure Type: Number
Unit of Measure: Participants
1054 5
4.Secondary Outcome
Title Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL
Hide Description Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL
Time Frame Week 4 Postdose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2)
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Overall Number of Participants Analyzed 1017 994
Measure Type: Number
Unit of Measure: Participants
1014 15
5.Secondary Outcome
Title Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL
Hide Description Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL
Time Frame Week 4 Postdose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2)
Hide Arm/Group Description:

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Overall Number of Participants Analyzed 1140 1119
Measure Type: Number
Unit of Measure: Participants
1133 12
Time Frame [Not Specified]
Adverse Event Reporting Description Number of subjects at risk included randomized subjects who had follow-up. Differing numbers of subjects were at risk for serious vs. other adverse experiences (AEs) as both serious and non-serious AEs were collected in the base period and only serious AEs were collected in the extension period.
 
Arm/Group Title Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Extension Study
Hide Arm/Group Description

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as "Completed Period" are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.

Extension study includes subjects from Group 2-Base Study who were vaccinated with quadrivalent HPV vaccine.

No data on non-serious adverse events were collected on this group during the extension study, hence no data are entered for them in the table.

All-Cause Mortality
Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Extension Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Extension Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46   56   1 
Blood and lymphatic system disorders       
Disseminated intravascular coagulation * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Cardiac disorders       
Aortic valve disease * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Cardiac arrest * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Myocarditis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Pericarditis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Gastritis * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Reflux oesophagitis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
General disorders       
Chills * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Face oedema * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Pyrexia * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Injection site joint movement impairment * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Injection site pain * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Immune system disorders       
Anaphylactic reaction * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Hypersensitivty * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Infections and infestations       
Appendicitis * 1  2/6021 (0.03%)  0/6033 (0.00%)  0/594 (0.00%) 
Cervicitis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Endometritis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Gastroenteritis * 1  2/6021 (0.03%)  1/6033 (0.02%)  0/594 (0.00%) 
Gastrointestinal infection * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Infective thrombosis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Pelvic Inflammatory disease * 1  0/6021 (0.00%)  2/6033 (0.03%)  0/594 (0.00%) 
Pneumonia * 1  2/6021 (0.03%)  1/6033 (0.02%)  0/594 (0.00%) 
Pyelonephritis * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Sepsis * 1  2/6021 (0.03%)  0/6033 (0.00%)  0/594 (0.00%) 
Septic Shock * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Typhoid fever * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Urinary tract infection * 1  0/6021 (0.00%)  2/6033 (0.03%)  0/594 (0.00%) 
Uterine infection * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Injury, poisoning and procedural complications       
Chemical poisoning * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Failed forceps delivery * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Intentional overdose * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Multiple injuries * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Overdose * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Post procedural haemorrhage * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Road traffic accident * 1  3/6021 (0.05%)  2/6033 (0.03%)  0/594 (0.00%) 
Thermal burn * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Thyroid cancer * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Nervous system disorders       
Convulsion * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Dizziness * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Headache * 1  2/6021 (0.03%)  1/6033 (0.02%)  0/594 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion threatened * 1  3/6021 (0.05%)  4/6033 (0.07%)  0/594 (0.00%) 
Breech presentation * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Brow presentation * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Cephalo-pelvic disproportion * 1  0/6021 (0.00%)  5/6033 (0.08%)  0/594 (0.00%) 
Cervix dystocia * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Ectopic pregnancy  1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Failed trial of labour * 1  3/6021 (0.05%)  3/6033 (0.05%)  0/594 (0.00%) 
Foetal distress syndrome * 1  3/6021 (0.05%)  2/6033 (0.03%)  0/594 (0.00%) 
Foetal malpresentation * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Hyperemesis gravidarum * 1  2/6021 (0.03%)  0/6033 (0.00%)  0/594 (0.00%) 
Imminent abortion * 1  0/6021 (0.00%)  1/6033 (0.02%)  1/594 (0.17%) 
Oligohydramnios * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Postpartum haemorrhage * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Pre-eclampsia * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Pregnancy induced hypertension * 1  2/6021 (0.03%)  1/6033 (0.02%)  0/594 (0.00%) 
Premature labour * 1  3/6021 (0.05%)  5/6033 (0.08%)  0/594 (0.00%) 
Premature rupture of membranes * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Prolonged pregnancy * 1  0/6021 (0.00%)  2/6033 (0.03%)  0/594 (0.00%) 
Uterine contractions during pregnancy * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Cervical incompetence * 1  0/6021 (0.00%)  2/6033 (0.03%)  0/594 (0.00%) 
Psychiatric disorders       
Bipolar disorder * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Completed suicide * 1  0/6021 (0.00%)  2/6033 (0.03%)  0/594 (0.00%) 
Panic attack * 1  0/6021 (0.00%)  0/6033 (0.00%)  1/594 (0.17%) 
Renal and urinary disorders       
Urinary retention * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Reproductive system and breast disorders       
Cervix haemorrhage uterine * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Ovarian cyst * 1  2/6021 (0.03%)  0/6033 (0.00%)  0/594 (0.00%) 
Vaginal laceration * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Vulvovaginal discomfort * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asphyxia * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Asthma * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Neonatal asphyxia * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Pneumomediastinum * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Pulmonary embolism * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Skin and subcutaneous tissue disorders       
Cutaneous vasculitis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Dermatitis contact * 1  0/6021 (0.00%)  1/6033 (0.02%)  0/594 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Hypertension * 1  1/6021 (0.02%)  1/6033 (0.02%)  0/594 (0.00%) 
Thrombophlebitis * 1  1/6021 (0.02%)  0/6033 (0.00%)  0/594 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Quadrivalent Human Papillomavirus Vaccine (Group 1) Placebo (Group 2) Extension Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   551   499   0 
General disorders       
Injection site erythema * 1  142/6019 (2.36%)  120/6031 (1.99%)  0/0 
Injection site pain * 1  503/6019 (8.36%)  433/6031 (7.18%)  0/0 
Injection site swelling * 1  97/6019 (1.61%)  76/6031 (1.26%)  0/0 
Nervous system disorders       
Headache * 1  162/6019 (2.69%)  167/6031 (2.77%)  0/0 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092534     History of Changes
Other Study ID Numbers: V501-015
2004_082
First Submitted: September 23, 2004
First Posted: September 28, 2004
Results First Submitted: July 20, 2009
Results First Posted: November 26, 2009
Last Update Posted: February 21, 2018