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A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00835380
First received: January 30, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatitis A Virus Infection
 Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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. [ 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) ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 80
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: VAQTA™

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835380

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00835380     History of Changes
Other Study ID Numbers: 2009_531, V251-069
Study First Received: January 30, 2009
Results First Received: October 19, 2009
Last Updated: April 21, 2010
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Virus Diseases
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 16, 2013