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Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00365716
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : August 3, 2010
Last Update Posted : October 7, 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 Papillomavirus Infections
Genital Diseases, Female
Interventions Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20
Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40
Biological: Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80
Biological: Placebo (mcg) (Aluminum Adjuvant)225
Biological: Placebo (mcg) (Aluminum Adjuvant) 450
Enrollment 1158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Extension 1 Extension 2
Hide Arm/Group Description

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy. This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
Period Title: Base Study (Day 1 to Month 7)
Started 290 284 292 146 146 0 0
Completed 269 260 271 136 139 0 0
Not Completed 21 24 21 10 7 0 0
Reason Not Completed
Randomized Not Vaccinated             1             2             0             0             0             0             0
Adverse Event             0             2             0             0             1             0             0
Lost to Follow-up             4             6             6             4             0             0             0
Other             0             1             0             0             0             0             0
Pregnancy             3             2             3             1             1             0             0
Protocol Violation             1             2             0             1             2             0             0
Withdrawal by Subject             12             9             12             4             3             0             0
Period Title: Long Term Follow-up (Month 7 toMonth 36)
Started 269 260 271 136 139 0 0
Completed 137 245 251 57 57 0 0
Not Completed 132 15 20 79 82 0 0
Reason Not Completed
Proceeded to Extension 1             114             0             0             69             75             0             0
Lost to Follow-up             6             8             5             4             3             0             0
Moved             3             2             1             2             0             0             0
Other             2             0             0             0             1             0             0
Protocol Violation             0             1             1             0             0             0             0
Withdrawal by Subject             7             4             13             4             3             0             0
Period Title: Extension 1
Started 0 0 0 0 0 241 0
Completed 0 0 0 0 0 219 0
Not Completed 0 0 0 0 0 22 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             1             0
Other             0             0             0             0             0             9             0
Moved             0             0             0             0             0             4             0
Withdrawal by Subject             0             0             0             0             0             3             0
Pregnancy             0             0             0             0             0             4             0
Protocol Violation             0             0             0             0             0             1             0
Period Title: Extension 2
Started 0 0 0 0 0 0 17 [1]
Completed 0 0 0 0 0 0 7
Not Completed 0 0 0 0 0 0 10
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             0             2
Other             0             0             0             0             0             0             3
Withdrawal by Subject             0             0             0             0             0             0             5
[1]
17 Participants continued into Extension 2 from Extension 1
Arm/Group Title Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Total
Hide Arm/Group Description

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

Total of all reporting groups
Overall Number of Baseline Participants 290 284 292 146 146 1158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 290 participants 284 participants 292 participants 146 participants 146 participants 1158 participants
20.2
(16 to 23)
20.0
(15 to 24)
20.1
(16 to 23)
20.0
(16 to 23)
20.1
(13 to 23)
20.0
(13 to 24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 290 participants 284 participants 292 participants 146 participants 146 participants 1158 participants
Female
290
 100.0%
284
 100.0%
292
 100.0%
146
 100.0%
146
 100.0%
1158
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 290 participants 284 participants 292 participants 146 participants 146 participants 1158 participants
Asian 7 11 5 6 5 34
Black 25 32 27 12 7 103
Hispanic American 15 15 10 10 11 61
Indian 0 0 2 0 0 2
Multi-racial 13 9 6 7 4 39
Native American 2 4 2 0 1 9
White 228 213 240 111 118 910
1.Primary Outcome
Title Number of Subjects With Injection Site Adverse Experiences
Hide Description [Not Specified]
Time Frame Days 1-5 following any vaccination visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All vaccinated subjects with adverse experience follow-up.
Arm/Group Title Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

Overall Number of Participants Analyzed 288 282 292 146 146
Measure Type: Number
Unit of Measure: Participants
247 248 266 107 115
2.Secondary Outcome
Title Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)
Hide Description [Not Specified]
Time Frame Through 36 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7
Arm/Group Title Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined
Hide Arm/Group Description:

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
Overall Number of Participants Analyzed 235 233
Measure Type: Number
Unit of Measure: Incidence per 100 person-years
0.7 6.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20, Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 89.5
Confidence Interval 95%
70.7 to 97.3
Estimation Comments

Vaccine Efficacy (% relative risk reduction)

Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.

Time Frame Adverse events (AEs) were collected from Day 1 until Month 7. AEs were collected on the subject’s vaccination report card daily for 14 days after each injection.
Adverse Event Reporting Description Subjects were observed for 30 minutes after each vaccination. Temperatures were recorded for 5 days after each injection (4 hours after injection and daily for the next 4 days). At Months 2, 3, 6, and 7, subjects were solicited for any gynecological health concerns and any SAEs that had occurred.
 
Arm/Group Title Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Extensions
Hide Arm/Group Description

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

  • There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.
  • There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

  • There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.

This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.

  • Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table.
All-Cause Mortality
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Extensions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Extensions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/288 (1.04%)   0/282 (0.00%)   2/292 (0.68%)   0/146 (0.00%)   3/146 (2.05%)   1/241 (0.41%) 
Gastrointestinal disorders             
Appendicitis  1  0/288 (0.00%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  1/146 (0.68%)  0/241 (0.00%) 
Kidney infection  1  0/288 (0.00%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  1/146 (0.68%)  0/241 (0.00%) 
Pyelonephritis  1  0/288 (0.00%)  0/282 (0.00%)  1/292 (0.34%)  0/146 (0.00%)  0/146 (0.00%)  0/241 (0.00%) 
Injury, poisoning and procedural complications             
Drug toxicity  1  0/288 (0.00%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  0/146 (0.00%)  1/241 (0.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Pancreatic carcinoma  1  1/288 (0.35%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  0/146 (0.00%)  0/241 (0.00%) 
Psychiatric disorders             
Depression  1  1/288 (0.35%)  0/282 (0.00%)  1/292 (0.34%)  0/146 (0.00%)  0/146 (0.00%)  0/241 (0.00%) 
Renal and urinary disorders             
Renal colic  1  1/288 (0.35%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  0/146 (0.00%)  0/241 (0.00%) 
Reproductive system and breast disorders             
Cervix haemorrhage uterine  1  0/288 (0.00%)  0/282 (0.00%)  0/292 (0.00%)  0/146 (0.00%)  1/146 (0.68%)  0/241 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 Placebo (mcg) (Aluminum Adjuvant) 225 Placebo (mcg) (Aluminum Adjuvant) 450 Extensions
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   245/288 (85.07%)   247/282 (87.59%)   263/292 (90.07%)   105/146 (71.92%)   114/146 (78.08%)   180/241 (74.69%) 
Gastrointestinal disorders             
Abdominal pain  1  13/288 (4.51%)  14/282 (4.96%)  16/292 (5.48%)  5/146 (3.42%)  9/146 (6.16%)  0/241 (0.00%) 
Abdominal pain upper  1  10/288 (3.47%)  16/282 (5.67%)  8/292 (2.74%)  7/146 (4.79%)  3/146 (2.05%)  0/241 (0.00%) 
Nausea  1  19/288 (6.60%)  23/282 (8.16%)  21/292 (7.19%)  13/146 (8.90%)  10/146 (6.85%)  0/241 (0.00%) 
General disorders             
Fatigue  1  26/288 (9.03%)  8/282 (2.84%)  23/292 (7.88%)  9/146 (6.16%)  9/146 (6.16%)  0/241 (0.00%) 
Pyrexia  1  30/288 (10.42%)  37/282 (13.12%)  41/292 (14.04%)  13/146 (8.90%)  16/146 (10.96%)  14/241 (5.81%) 
Injection Site Erythema  1  75/288 (26.04%)  59/282 (20.92%)  80/292 (27.40%)  31/146 (21.23%)  31/146 (21.23%)  35/241 (14.52%) 
Injection Site Haematoma  1  17/288 (5.90%)  9/282 (3.19%)  14/292 (4.79%)  8/146 (5.48%)  3/146 (2.05%)  0/241 (0.00%) 
Injection Site Pain  1  245/288 (85.07%)  247/282 (87.59%)  263/292 (90.07%)  105/146 (71.92%)  114/146 (78.08%)  180/241 (74.69%) 
Injection Site Swelling  1  80/288 (27.78%)  74/282 (26.24%)  95/292 (32.53%)  23/146 (15.75%)  29/146 (19.86%)  46/241 (19.09%) 
Infections and infestations             
Influenza  1  13/288 (4.51%)  17/282 (6.03%)  15/292 (5.14%)  7/146 (4.79%)  9/146 (6.16%)  0/241 (0.00%) 
Nasopharyngitis  1  20/288 (6.94%)  23/282 (8.16%)  20/292 (6.85%)  17/146 (11.64%)  9/146 (6.16%)  0/241 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  12/288 (4.17%)  10/282 (3.55%)  8/292 (2.74%)  9/146 (6.16%)  1/146 (0.68%)  0/241 (0.00%) 
Pain in extremity  1  9/288 (3.13%)  6/282 (2.13%)  4/292 (1.37%)  7/146 (4.79%)  9/146 (6.16%)  0/241 (0.00%) 
Nervous system disorders             
Headache  1  117/288 (40.63%)  103/282 (36.52%)  116/292 (39.73%)  74/146 (50.68%)  53/146 (36.30%)  60/241 (24.90%) 
Reproductive system and breast disorders             
Dysmenorrhoea  1  10/288 (3.47%)  8/282 (2.84%)  13/292 (4.45%)  15/146 (10.27%)  6/146 (4.11%)  0/241 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain  1  20/288 (6.94%)  10/282 (3.55%)  17/292 (5.82%)  11/146 (7.53%)  10/146 (6.85%)  0/241 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Name/Title: Senior Vice President,Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00365716     History of Changes
Other Study ID Numbers: V501-007
2006_516
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: May 19, 2010
Results First Posted: August 3, 2010
Last Update Posted: October 7, 2015