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A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

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: NCT01047345
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : December 22, 2014
Last Update Posted : November 27, 2018
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 Cancers
Vulvar Cancers
Vaginal Cancers
Genital Warts
Interventions Biological: V503
Biological: Placebo to V503
Enrollment 924
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study 9vHPV Vaccine - Extension Study
Hide Arm/Group Description Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study. Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
Period Title: Base Study
Started 618 306 0
Vaccination 1 615 306 0
Vaccination 2 604 304 0
Vaccination 3 597 300 0
Completed 596 [1] 300 0
Not Completed 22 6 0
Reason Not Completed
Adverse Event             3             0             0
Lost to Follow-up             4             1             0
Protocol Violation             3             1             0
Withdrawal by Subject             12             4             0
[1]
Includes 1 participant for whom completion status is unknown
Period Title: Extension
Started 0 0 102 [1]
Vaccination 4 0 0 102
Vaccination 5 0 0 99
Vaccination 6 0 0 95 [2]
Completed 0 0 96
Not Completed 0 0 6
Reason Not Completed
Withdrawal by Subject             0             0             1
Lost to Follow-up             0             0             5
[1]
Not all eligible participants elected to participate in extension
[2]
1 participant received 6th vaccination outside the context of study but completed the study.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study Total
Hide Arm/Group Description Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study. Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. Total of all reporting groups
Overall Number of Baseline Participants 618 306 924
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 618 participants 306 participants 924 participants
12 to 15 years 122 60 182
16 to 26 years 496 246 742
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 618 participants 306 participants 924 participants
Female
618
 100.0%
306
 100.0%
924
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.
Time Frame up to 5 days after any vaccination - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 608 305
Measure Type: Number
Unit of Measure: Percentage of Participants
91.1 43.9
2.Primary Outcome
Title Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) – Base Study
Hide Description Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
Time Frame up to 5 days after any vaccination - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available temperature data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 604 304
Measure Type: Number
Unit of Measure: Percentage of Participants
6.5 3.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study, Placebo - Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
0.5 to 6.2
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Who Experience a Systemic AE – Base Study
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Time Frame up to 14 days after any vaccination - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 608 305
Measure Type: Number
Unit of Measure: Percentage of Participants
59.7 55.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study, Placebo - Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-2.8 to 10.8
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination – Base Study
Hide Description An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
Time Frame up to 14 days after any vaccination - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 608 305
Measure Type: Number
Unit of Measure: Percentage of Participants
0.3 0.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study, Placebo - Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.5 to 0.9
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study– Base Study
Hide Description An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” is defined as a vaccine-related SAE.
Time Frame Up to 7 months - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 608 305
Measure Type: Number
Unit of Measure: Percentage of Participants
0.2 0.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study, Placebo - Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.7 to 0.6
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percentage of Participants Who Experience a Severe Injection-site AE – Base Study
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
Time Frame up to 5 days after any vaccination - Base Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 608 305
Measure Type: Number
Unit of Measure: Percentage of Participants
11.2 1.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study, Placebo - Base Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen & Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
7.5 to 13.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
Hide Description Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Time Frame 4 weeks post-vaccination 3 (Month 7; End of Base Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study
Hide Arm/Group Description:
Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
Overall Number of Participants Analyzed 515 261
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Anti-HPV 6 (n=511; n=251)
100.0
(99.3 to 100.0)
100.0
(98.5 to 100.0)
Anti-HPV 11 (n=515; n=261)
100.0
(99.3 to 100.0)
99.6
(97.9 to 100.0)
Anti-HPV 16 (n=515; n=261)
100.0
(99.3 to 100.0)
100.0
(98.6 to 100.0)
Anti-HPV 18 (n=515; n=261)
100.0
(99.3 to 100.0)
85.4
(80.6 to 89.5)
Anti-HPV 31 (n=515; n=261)
99.8
(98.9 to 100.0)
23.8
(18.7 to 29.4)
Anti-HPV 33 (n=515; n=261)
99.8
(98.9 to 100.0)
8.0
(5.0 to 12.0)
Anti-HPV 45 (n=515; n=261)
98.3
(96.7 to 99.2)
3.4
(1.6 to 6.4)
Anti-HPV 52 (n=515; n=261)
99.6
(98.6 to 100.0)
3.8
(1.9 to 6.9)
Anti-HPV 58 (n=515; n=261)
99.8
(98.9 to 100.0)
9.2
(6.0 to 13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study
Comments Anti-HPV 31
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroconversion rate
Estimated Value 99.8
Confidence Interval (2-Sided) 95%
98.9 to 100.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study
Comments Anti-HPV 33
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroconversion Rate
Estimated Value 99.8
Confidence Interval (2-Sided) 95%
98.9 to 100.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study
Comments Anti-HPV 45
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroconversion Rate
Estimated Value 98.3
Confidence Interval (2-Sided) 95%
96.7 to 99.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study
Comments Anti-HPV 52
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroconversion Rate
Estimated Value 99.6
Confidence Interval (2-Sided) 95%
98.6 to 100.0
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 9vHPV Vaccine - Base Study
Comments Anti-HPV 58
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Seroconversion Rate
Estimated Value 99.8
Confidence Interval (2-Sided) 95%
98.9 to 100.0
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Percentage of Participants Who Experience an SAE- Extension Study
Hide Description An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.
Time Frame up to Month 7 - Extension Study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 vaccination in Extension Study and had available follow-up data.
Arm/Group Title 9vHPV Vaccine - Extension Study
Hide Arm/Group Description:
Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
Overall Number of Participants Analyzed 99
Measure Type: Number
Unit of Measure: Percentage of Participants
2.0
Time Frame Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Non-serious systemic AEs) and up to 7 months (Serious AEs) - Base Study and Extension Study
Adverse Event Reporting Description Population included all participants who received at least 1 vaccination and had available follow-up data. Only SAEs were collected systematically in the Extension Study. Although some unsolicited non-serious AEs were reported during the Extension Study, none exceeded the 5% cut-off.
 
Arm/Group Title 9vHPV Vaccine - Base Study Placebo - Base Study 9vHPV Vaccine - Extension Study
Hide Arm/Group Description Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study. Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study. Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
All-Cause Mortality
9vHPV Vaccine - Base Study Placebo - Base Study 9vHPV Vaccine - Extension Study
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
9vHPV Vaccine - Base Study Placebo - Base Study 9vHPV Vaccine - Extension Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/608 (0.49%)      3/305 (0.98%)      2/99 (2.02%)    
Gastrointestinal disorders       
Abdominal pain  1  0/608 (0.00%)  0 0/305 (0.00%)  0 1/99 (1.01%)  1
Diarrhoea  1  0/608 (0.00%)  0 0/305 (0.00%)  0 1/99 (1.01%)  1
Infections and infestations       
Appendicitis  1  1/608 (0.16%)  1 0/305 (0.00%)  0 0/99 (0.00%)  0
Tonsillitis  1  1/608 (0.16%)  1 0/305 (0.00%)  0 0/99 (0.00%)  0
Injury, poisoning and procedural complications       
Lumbar vertebral fracture  1  0/608 (0.00%)  0 1/305 (0.33%)  1 0/99 (0.00%)  0
Thoracic vertebral fracture  1  0/608 (0.00%)  0 1/305 (0.33%)  1 0/99 (0.00%)  0
Nervous system disorders       
Migraine  1  0/608 (0.00%)  0 1/305 (0.33%)  1 0/99 (0.00%)  0
Syncope  1  1/608 (0.16%)  1 0/305 (0.00%)  0 0/99 (0.00%)  0
Surgical and medical procedures       
Abortion induced  1  0/608 (0.00%)  0 1/305 (0.33%)  1 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
9vHPV Vaccine - Base Study Placebo - Base Study 9vHPV Vaccine - Extension Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   566/608 (93.09%)      197/305 (64.59%)      0/99 (0.00%)    
Gastrointestinal disorders       
Nausea  1  52/608 (8.55%)  67 12/305 (3.93%)  13 0/99 (0.00%)  0
General disorders       
Injection site erythema  1  258/608 (42.43%)  420 26/305 (8.52%)  33 0/99 (0.00%)  0
Injection site pain  1  549/608 (90.30%)  1392 117/305 (38.36%)  182 0/99 (0.00%)  0
Injection site pruritus  1  48/608 (7.89%)  68 4/305 (1.31%)  5 0/99 (0.00%)  0
Injection site swelling  1  298/608 (49.01%)  558 18/305 (5.90%)  27 0/99 (0.00%)  0
Pyrexia  1  42/608 (6.91%)  50 10/305 (3.28%)  10 0/99 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  47/608 (7.73%)  55 19/305 (6.23%)  20 0/99 (0.00%)  0
Nervous system disorders       
Dizziness  1  31/608 (5.10%)  34 6/305 (1.97%)  8 0/99 (0.00%)  0
Headache  1  190/608 (31.25%)  318 81/305 (26.56%)  150 0/99 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  40/608 (6.58%)  46 12/305 (3.93%)  14 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01047345     History of Changes
Other Study ID Numbers: V503-006
2010_504 ( Other Identifier: Merck Registration Number )
First Submitted: January 11, 2010
First Posted: January 12, 2010
Results First Submitted: December 12, 2014
Results First Posted: December 22, 2014
Last Update Posted: November 27, 2018