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Trial record 2 of 2 for:    gardasil 9 | Phase 1

An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)

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: NCT00635830
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : August 20, 2009
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HPV Infections
Intervention Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 18 to 26 Years of Age Group 9 to 17 Years of Age Group
Hide Arm/Group Description

18 to 26 years of age group was enrolled to evaluate safety firstly.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title 18 to 26 Years of Age Group 9 to 17 Years of Age Group Total
Hide Arm/Group Description

18 to 26 years of age group was enrolled to evaluate safety firstly.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
23.64  (2.39) 13.82  (9.6) 18.73  (5.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
20
 100.0%
20
 100.0%
40
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Body Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees Celsius
Number Analyzed 20 participants 20 participants 40 participants
36.64  (0.35) 36.35  (0.24) 36.49  (0.33)
Pulse  
Mean (Standard Deviation)
Unit of measure:  Beats per minute (BPM)
Number Analyzed 20 participants 20 participants 40 participants
71.75  (4.17) 65.40  (2.68) 68.58  (4.72)
1.Primary Outcome
Title Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
Hide Description All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Time Frame For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 18 to 26 Years of Age Group 9 to 17 Years of Age Group
Hide Arm/Group Description:

18 to 26 years of age group was enrolled to evaluate safety firstly.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Experiences 0 0
Systemic Adverse Experiences 7 10
Injection-Site Complaints 4 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18 to 26 Years of Age Group 9 to 17 Years of Age Group
Hide Arm/Group Description

18 to 26 years of age group was enrolled to evaluate safety firstly.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.

Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.

All-Cause Mortality
18 to 26 Years of Age Group 9 to 17 Years of Age Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
18 to 26 Years of Age Group 9 to 17 Years of Age Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
18 to 26 Years of Age Group 9 to 17 Years of Age Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10      11    
Eye disorders     
Conjunctivitis   1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
Nausea   0/20 (0.00%)  0 1/20 (5.00%)  1
Abdominal pain   1/20 (5.00%)  1 1/20 (5.00%)  1
Vomiting   0/20 (0.00%)  0 1/20 (5.00%)  1
Gastritis   1/20 (5.00%)  1 0/20 (0.00%)  0
General disorders     
Injection site painness   4/20 (20.00%)  4 7/20 (35.00%)  7
Allergic reaction   0/20 (0.00%)  0 1/20 (5.00%)  1
Fever   3/20 (15.00%)  3 3/20 (15.00%)  3
Muscle pain   0/20 (0.00%)  0 3/20 (15.00%)  3
Fatigue   1/20 (5.00%)  1 2/20 (10.00%)  2
Hypodynamia   1/20 (5.00%)  1 2/20 (10.00%)  2
Nervous system disorders     
Headache   0/20 (0.00%)  0 3/20 (15.00%)  3
Reproductive system and breast disorders     
Menstrual disorder   1/20 (5.00%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Coughing   0/20 (0.00%)  0 3/20 (15.00%)  3
Upper respiratory infection   0/20 (0.00%)  0 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
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: 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: NCT00635830    
Other Study ID Numbers: V501-035
2008_003
First Submitted: March 3, 2008
First Posted: March 14, 2008
Results First Submitted: March 17, 2009
Results First Posted: August 20, 2009
Last Update Posted: October 9, 2015