Completed

NCT Number: NCT00835380

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

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

Completed

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Key information

Conditions

Hepatitis A Virus Infection

Age range

12 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatitis A Vaccine, Purified Inactivated (VAQTA™)

Biological

Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.

Other names: VAQTA™

Primary outcomes

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.

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)

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 outcomes

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

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

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Feb 3, 2009
Registry last updated: Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.