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Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00326183
First received: May 12, 2006
Last updated: January 31, 2017
Last verified: January 2017
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Purpose
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 |
|---|---|---|
| Hepatitis A Measles Mumps Rubella Chickenpox | Biological: VAQTA® Biological: ProQuad | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Participants With 1 or More Serious Vaccine-Related Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
- Participants With 1 or More Injection-Site Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ]
- Participants With Measles-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
- Participants With Measles-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
- Participants With Mumps-Like Symptoms After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
- Participants With Mumps-Like Symptoms After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
- Participants With Rubella-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
- Participants With Rubella-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
- Participants With Varicella/Zoster-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ]
- Participants With Varicella/Zoster-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ]
- Participants With Elevated Temperature (>=102.2F/39.0C) [ Time Frame: Days 1 to 5 After Any Vaccination ]
Secondary Outcome Measures:
- Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ]
| Enrollment: | 1800 |
| Study Start Date: | March 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Arm 1: vaccine
|
Biological: VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
Other Name: V251
|
|
Active Comparator: 2
Arm 2: Active comparator
|
Biological: VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
Other Name: V251
Biological: ProQuad
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
|
Eligibility| Ages Eligible for Study: | 12 Months to 17 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster
- No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)
Exclusion Criteria:
- Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination
- History of allergy to any vaccine component
- History of seizure disorder
- Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy
- Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections
- Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326183
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326183
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00326183 History of Changes |
| Other Study ID Numbers: |
V251-066 2006_023 |
| Study First Received: | May 12, 2006 |
| Results First Received: | October 21, 2008 |
| Last Updated: | January 31, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Additional relevant MeSH terms:
|
Hepatitis Measles Hepatitis A Rubella Chickenpox Liver Diseases Digestive System Diseases Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections |
RNA Virus Infections Virus Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Rubivirus Infections Togaviridae Infections Herpesviridae Infections DNA Virus Infections |
ClinicalTrials.gov processed this record on June 22, 2017