Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326183
• Other study ID #: V251-066
• Secondary ID: 2006_023
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 2007
• Est. completion date: January 15, 2008

Study information

• Verified date: January 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: January 15, 2008
• Est. primary completion date: January 15, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 17 Months

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Hepatitis
• Hepatitis A
• Measles
• Mumps
• Rubella

Intervention

Biological:
• VAQTA®
0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
• ProQuad
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schödel FP, Lee AW. Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2018 Nov 15:1-7. doi: 10.1080/21645515.2018.1530934. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With 1 or More Serious Vaccine-Related Adverse Experiences		Days 1 to 14 after any vaccination
Primary	Participants With 1 or More Injection-Site Adverse Experiences		Days 1 to 14 after any vaccination
Primary	Participants With Measles-Like Rash After First Vaccination		Days 1 to 28 After First Vaccination
Primary	Participants With Measles-Like Rash After Second Vaccination		Days 1 to 28 After Second Vaccination
Primary	Participants With Mumps-Like Symptoms After First Vaccination		Days 1 to 28 After First Vaccination
Primary	Participants With Mumps-Like Symptoms After Second Vaccination		Days 1 to 28 After Second Vaccination
Primary	Participants With Rubella-Like Rash After First Vaccination		Days 1 to 28 After First Vaccination
Primary	Participants With Rubella-Like Rash After Second Vaccination		Days 1 to 28 After Second Vaccination
Primary	Participants With Varicella/Zoster-Like Rash After First Vaccination		Days 1 to 28 After First Vaccination
Primary	Participants With Varicella/Zoster-Like Rash After Second Vaccination		Days 1 to 28 After Second Vaccination
Primary	Participants With Elevated Temperature (>=102.2F/39.0C)		Days 1 to 5 After Any Vaccination
Secondary	Participants With 1 or More Systemic Adverse Experiences		Days 1 to 14 After Any Vaccination