Phase 3
Completed N=80
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Source: ClinicalTrials.gov NCT00835380 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: 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. — 2; 68 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
2; 68 | — |
| SECONDARY 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 |
0; 10; 54 | — |
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
Data sourced from ClinicalTrials.gov (NCT00835380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.