Back to resultsA Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Primary Purpose
Hepatitis A Virus Infection
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hepatitis A Vaccine, Purified Inactivated (VAQTA™)
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A Virus Infection
Eligibility Criteria
Inclusion Criteria:
- Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination
Exclusion Criteria:
- Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection
- Subject has a fever 72 hours prior to first injection
- Subject has already been vaccinated for Hepatitis A
- Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine
- Subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
VAQTA™
Outcomes
Primary Outcome Measures
Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.
HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL.
Secondary Outcome Measures
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's 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 each injection.
Full Information
NCT ID
NCT00835380
First Posted
January 30, 2009
Last Updated
March 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00835380
Brief Title
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Official Title
A Phase III Open-Label Study of Immunogenicity, Safety, and Tolerability of 2 Doses of VAQTA™ (Formalin, Inactivated, Alum-Adjuvanted Hepatitis A Vaccine) in Healthy Children 12 to 23 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A Virus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
VAQTA™
Intervention Type
Biological
Intervention Name(s)
Hepatitis A Vaccine, Purified Inactivated (VAQTA™)
Other Intervention Name(s)
VAQTA™
Intervention Description
Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.
Primary Outcome Measure Information:
Title
Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.
Description
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.
HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL.
Time Frame
Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)
Secondary Outcome Measure Information:
Title
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
Description
All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's 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 each injection.
Time Frame
For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination
Exclusion Criteria:
Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection
Subject has a fever 72 hours prior to first injection
Subject has already been vaccinated for Hepatitis A
Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine
Subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
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