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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00326183 |
Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.
Condition | Intervention | Phase |
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Hepatitis A Measles Mumps Rubella Chickenpox |
Biological: VAQTA® Biological: ProQuad |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age |
Enrollment: | 1800 |
Study Start Date: | May 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Arm 1: vaccine
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Biological: VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
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2: Active Comparator
Arm 2: Active comparator
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Biological: VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
Biological: ProQuad
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
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Ages Eligible for Study: | 12 Months to 17 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Dr. Barry Gertz, Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_023, V251-066 |
Study First Received: | May 12, 2006 |
Results First Received: | October 21, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00326183 |
Health Authority: | United States: Food and Drug Administration |
Mouth Diseases Herpes Zoster Liver Diseases Paramyxoviridae Infections Measles Picornaviridae Infections Chickenpox Hepatitis, Viral, Human Healthy Rubella Togaviridae Infections |
Herpesviridae Infections Hepatitis Virus Diseases Digestive System Diseases Hepatitis A DNA Virus Infections Chicken pox Stomatognathic Diseases Enterovirus Infections Salivary Gland Diseases Mumps |
Rubivirus Infections Parotid Diseases RNA Virus Infections Morbillivirus Infections |
Rubulavirus Infections Parotitis Mononegavirales Infections |