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

NCT00835380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-13

Study results available
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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.

Conditions

  • Hepatitis A Virus Infection

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835380 on ClinicalTrials.gov