A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)

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

This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.

Study Overview

• Status: Completed
• Conditions: Hepatitis A Virus Infection
• Intervention / Treatment: Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; VAQTA™	Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™); Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.; Other Names: VAQTA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: V251-069; 2009_531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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