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Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092521
Recruitment Status : Completed
First Posted : September 28, 2004
Results First Posted : November 20, 2009
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Cervical Cancer
Genital Warts
Interventions Biological: V501
Biological: Comparator: Placebo
Biological: Human Papillomavirus (HPV) 16 Monovalent
Enrollment 5759

Recruitment Details The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.
Pre-assignment Details  
Arm/Group Title Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
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 Human papillomavirus (HPV) vaccine.

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

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

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

This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
Period Title: Vaccination (Day 1 Through Month 7)
Started 2723 304 2732 0
Completed 2583 290 2586 0
Not Completed 140 14 146 0
Reason Not Completed
Randomized Not Vaccinated             6             0             7             0
Adverse Event             1             0             7             0
Death             0             0             1             0
Lost to Follow-up             51             6             44             0
Pregnancy             5             0             7             0
Withdrawal by Subject             59             7             62             0
Moved             14             1             18             0
Unblinded             2             0             0             0
New Medical History (Not AE)             2             0             0             0
Period Title: Follow-Up (After Month 7)
Started 2599 [1] 291 [1] 2607 [1] 0
Completed 2353 155 1959 0
Not Completed 246 136 648 0
Reason Not Completed
Subjects Continuing             34             4             35             0
Subjects in Extension             13             109             412             0
Adverse Event             1             0             0             0
Death             2             0             1             0
Lost to Follow-up             113             14             108             0
Protocol Violation             1             1             5             0
Withdrawal by Subject             40             6             51             0
Moved             32             2             28             0
Site Terminated             3             0             3             0
Travel             2             0             0             0
Visits Compressed             5             0             5             0
[1]
Includes subjects who did not receive 3 doses of vaccine/placebo but continued into the follow-up
Period Title: Extension Study (Group 4)
Started 0 0 0 844
Initiated Extension Study 0 0 0 829
Received >=1 Dose in Extension Study 0 0 0 801
Completed 0 0 0 635
Not Completed 0 0 0 209
Reason Not Completed
Excluded ineligible for extension             0             0             0             23
Adverse Event             0             0             0             2
Lost to Follow-up             0             0             0             87
Pregnancy             0             0             0             4
Protocol Violation             0             0             0             2
Withdrawal by Subject             0             0             0             46
Moved             0             0             0             16
Site Terminated             0             0             0             4
Unable/unwilling to return             0             0             0             25
Arm/Group Title Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo 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 the Monovalent (HPV 16) HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

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

Total of all reporting groups
Overall Number of Baseline Participants 2723 304 2732 5759
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2723 participants 304 participants 2732 participants 5759 participants
20.2  (1.8) 20.2  (1.74) 20.3  (1.8) 20.3  (1.8)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2723 participants 304 participants 2732 participants 5759 participants
20
(16 to 24)
20
(16 to 24)
20
(16 to 24)
20
(16 to 24)
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
16 to 24 Years of Age Number Analyzed 2723 participants 304 participants 2732 participants 5759 participants
2723 304 2732 5759
[1]
Measure Description: Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2723 participants 304 participants 2732 participants 5759 participants
Female
2723
 100.0%
304
 100.0%
2732
 100.0%
5759
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2723 participants 304 participants 2732 participants 5759 participants
Asian 151 27 165 343
Black 136 5 167 308
Hispanic American 567 93 566 1226
Native American 10 2 10 22
White 1600 171 1558 3329
Other - Unspecified 259 6 266 531
1.Primary Outcome
Title Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
Hide Description [Not Specified]
Time Frame Follow-up through end of study (4 years)
Show Outcome Measure DataHide 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. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.
Arm/Group Title Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 3 - Base Study Placebo
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 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

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

Overall Number of Participants Analyzed 2241 2258
Measure Type: Number
Unit of Measure: incidence rate per 100 person-years
0 1.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine, Group 3 - Base Study Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent relative risk reduction
Estimated Value 100
Confidence Interval 95%
95.1 to 100
Estimation Comments Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter
2.Primary Outcome
Title Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]
Hide Description [Not Specified]
Time Frame Follow-up through end of study (4 years)
Show Outcome Measure DataHide 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 follow-up data.

Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.

Arm/Group Title Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 3 - Base Study Placebo
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 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

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

Overall Number of Participants Analyzed 2261 2279
Measure Type: Number
Unit of Measure: incidence rate per 100 person-years
0 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine, Group 3 - Base Study Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent relative risk reduction
Estimated Value 100
Confidence Interval 95%
94.9 to 100
Estimation Comments CI based on binomial tail probabilities and not from a dispersion parameter
Time Frame [Not Specified]
Adverse Event Reporting Description Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received >=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
 
Arm/Group Title Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
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 the Monovalent (HPV 16) HPV vaccine.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.

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

This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.
All-Cause Mortality
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/2673 (1.87%)   4/299 (1.34%)   45/2672 (1.68%)   5/801 (0.62%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Gastrointestinal disorders         
Gastric Ulcer * 1  0/2673 (0.00%)  0/299 (0.00%)  0/2672 (0.00%)  1/801 (0.12%) 
Hepatobiliary disorders         
Cholecystitis * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Cholelithiasis * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Immune system disorders         
Allergy to vaccine * 1  0/2673 (0.00%)  0/299 (0.00%)  0/2672 (0.00%)  1/801 (0.12%) 
Infections and infestations         
Anogenital warts * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Appendicitis * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Breast abscess * 1  0/2673 (0.00%)  1/299 (0.33%)  0/2672 (0.00%)  0/801 (0.00%) 
Endometritis decidual * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Enterocolitis infectious * 1  0/2673 (0.00%)  1/299 (0.33%)  0/2672 (0.00%)  0/801 (0.00%) 
Gastroenteritis * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  1/801 (0.12%) 
Pelvic inflammatory disease * 1  2/2673 (0.07%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Pharyngitis * 1  0/2673 (0.00%)  0/299 (0.00%)  0/2672 (0.00%)  1/801 (0.12%) 
Post procedural infection * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Pyelonephritis * 1  2/2673 (0.07%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Tonsillitis streptococcal * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Urinary tract infection * 1  2/2673 (0.07%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Varicella * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Injury, poisoning and procedural complications         
Abdominal injury  1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Accidental poisoning * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Head injury * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Injury * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Multiple injuries * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Operative haemorrhage * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Overdose * 1  16/2673 (0.60%)  2/299 (0.67%)  21/2672 (0.79%)  0/801 (0.00%) 
Post procedural haemorrhage * 1  1/2673 (0.04%)  0/299 (0.00%)  3/2672 (0.11%)  0/801 (0.00%) 
Road traffic accident * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Nervous system disorders         
Convulsion * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Dizziness * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Facial palsy * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Headache * 1  1/2673 (0.04%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Syncope * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Transient ischemic attack * 1  0/2673 (0.00%)  0/299 (0.00%)  0/2672 (0.00%)  1/801 (0.12%) 
Pregnancy, puerperium and perinatal conditions         
Abortion threatened  1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Breech presentation * 1  1/2673 (0.04%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Cephalo-pelvic disproportion * 1  2/2673 (0.07%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Cervix dystocia * 1  4/2673 (0.15%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Failed induction of labor * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Failed trial of labor * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Fetal distress syndrome * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Fetal malposition * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Oligohydramnios * 1  1/2673 (0.04%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Pre-eclampsia * 1  1/2673 (0.04%)  0/299 (0.00%)  3/2672 (0.11%)  0/801 (0.00%) 
Premature labor * 1  2/2673 (0.07%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Premature rupture of membranes * 1  2/2673 (0.07%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Prolonged labor * 1  2/2673 (0.07%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Transverse presentation * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Psychiatric disorders         
Completed suicide * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Renal and urinary disorders         
Renal failure * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Reproductive system and breast disorders         
Cervix haemorrhage uterine * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Asthma * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Bronchospasm * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Hyperventilation * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Pulmonary embolism * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Vascular disorders         
Deep vein thrombosis * 1  0/2673 (0.00%)  0/299 (0.00%)  1/2672 (0.04%)  0/801 (0.00%) 
Hypotension * 1  1/2673 (0.04%)  0/299 (0.00%)  0/2672 (0.00%)  0/801 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine Group 2 - Base Study Monovalent HPV (Type 16) Vaccine Group 3 - Base Study Placebo Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2458/2673 (91.96%)   276/299 (92.31%)   2331/2672 (87.24%)   0/0 
Gastrointestinal disorders         
Abdominal pain * 1  88/2673 (3.29%)  8/299 (2.68%)  81/2672 (3.03%)  0/0 
Abdominal pain upper * 1  82/2673 (3.07%)  5/299 (1.67%)  87/2672 (3.26%)  0/0 
Diarrhea * 1  105/2673 (3.93%)  9/299 (3.01%)  96/2672 (3.59%)  0/0 
Dyspepsia * 1  17/2673 (0.64%)  5/299 (1.67%)  16/2672 (0.60%)  0/0 
Gastritis * 1  22/2673 (0.82%)  4/299 (1.34%)  13/2672 (0.49%)  0/0 
Nausea * 1  210/2673 (7.86%)  23/299 (7.69%)  174/2672 (6.51%)  0/0 
Toothache * 1  48/2673 (1.80%)  4/299 (1.34%)  40/2672 (1.50%)  0/0 
Vomiting * 1  62/2673 (2.32%)  9/299 (3.01%)  56/2672 (2.10%)  0/0 
General disorders         
Asthenia * 1  29/2673 (1.08%)  7/299 (2.34%)  25/2672 (0.94%)  0/0 
Fatigue * 1  73/2673 (2.73%)  12/299 (4.01%)  102/2672 (3.82%)  0/0 
Malaise * 1  47/2673 (1.76%)  3/299 (1.00%)  40/2672 (1.50%)  0/0 
Pain * 1  19/2673 (0.71%)  3/299 (1.00%)  26/2672 (0.97%)  0/0 
Pyrexia * 1  436/2673 (16.31%)  33/299 (11.04%)  348/2672 (13.02%)  0/0 
Injection site erythema  1  659/2673 (24.65%)  84/299 (28.09%)  450/2672 (16.84%)  0/0 
Injection site haematoma  1  94/2673 (3.52%)  6/299 (2.01%)  97/2672 (3.63%)  0/0 
Injection site hypersensitivity  1  27/2673 (1.01%)  9/299 (3.01%)  22/2672 (0.82%)  0/0 
Injection site pain  1  2281/2673 (85.33%)  242/299 (80.94%)  2014/2672 (75.37%)  0/0 
Injection site pruritus  1  109/2673 (4.08%)  12/299 (4.01%)  80/2672 (2.99%)  0/0 
Injection site reaction  1  22/2673 (0.82%)  4/299 (1.34%)  17/2672 (0.64%)  0/0 
Injection site swelling  1  694/2673 (25.96%)  70/299 (23.41%)  413/2672 (15.46%)  0/0 
Infections and infestations         
Gastroenteritis * 1  17/2673 (0.64%)  3/299 (1.00%)  18/2672 (0.67%)  0/0 
Influenza * 1  124/2673 (4.64%)  18/299 (6.02%)  113/2672 (4.23%)  0/0 
Nasopharyngitis * 1  185/2673 (6.92%)  22/299 (7.36%)  166/2672 (6.21%)  0/0 
Pharyngitis * 1  32/2673 (1.20%)  3/299 (1.00%)  31/2672 (1.16%)  0/0 
Sinusitis * 1  22/2673 (0.82%)  3/299 (1.00%)  18/2672 (0.67%)  0/0 
Tonsillitis * 1  26/2673 (0.97%)  2/299 (0.67%)  29/2672 (1.09%)  0/0 
Upper respiratory tract infection * 1  36/2673 (1.35%)  9/299 (3.01%)  42/2672 (1.57%)  0/0 
Vulvovaginal candidiasis * 1  10/2673 (0.37%)  4/299 (1.34%)  16/2672 (0.60%)  0/0 
Injury, poisoning and procedural complications         
Procedural pain * 1  4/2673 (0.15%)  3/299 (1.00%)  4/2672 (0.15%)  0/0 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  27/2673 (1.01%)  0/299 (0.00%)  25/2672 (0.94%)  0/0 
Back Pain * 1  68/2673 (2.54%)  10/299 (3.34%)  63/2672 (2.36%)  0/0 
Muscle Spasms * 1  14/2673 (0.52%)  3/299 (1.00%)  12/2672 (0.45%)  0/0 
Myalgia * 1  49/2673 (1.83%)  6/299 (2.01%)  54/2672 (2.02%)  0/0 
Pain in Extremity * 1  55/2673 (2.06%)  7/299 (2.34%)  57/2672 (2.13%)  0/0 
Nervous system disorders         
Dizziness * 1  123/2673 (4.60%)  18/299 (6.02%)  114/2672 (4.27%)  0/0 
Headache * 1  802/2673 (30.00%)  103/299 (34.45%)  76/2672 (2.84%)  0/0 
Migraine * 1  23/2673 (0.86%)  3/299 (1.00%)  15/2672 (0.56%)  0/0 
Somnolence * 1  30/2673 (1.12%)  0/299 (0.00%)  32/2672 (1.20%)  0/0 
Psychiatric disorders         
Insomnia * 1  35/2673 (1.31%)  2/299 (0.67%)  23/2672 (0.86%)  0/0 
Reproductive system and breast disorders         
Dysmenorrhea * 1  106/2673 (3.97%)  11/299 (3.68%)  100/2672 (3.74%)  0/0 
Pelvic Pain * 1  14/2673 (0.52%)  4/299 (1.34%)  22/2672 (0.82%)  0/0 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  59/2673 (2.21%)  6/299 (2.01%)  40/2672 (1.50%)  0/0 
Nasal congestion * 1  26/2673 (0.97%)  3/299 (1.00%)  15/2672 (0.56%)  0/0 
Oropharyngeal pain * 1  109/2673 (4.08%)  14/299 (4.68%)  116/2672 (4.34%)  0/0 
Skin and subcutaneous tissue disorders         
Dermatitis allergic * 1  5/2673 (0.19%)  3/299 (1.00%)  10/2672 (0.37%)  0/0 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
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
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092521     History of Changes
Other Study ID Numbers: V501-013
2004_081
First Submitted: September 23, 2004
First Posted: September 28, 2004
Results First Submitted: August 3, 2009
Results First Posted: November 20, 2009
Last Update Posted: September 25, 2015