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

NCT00326183 | Completed Phase 4 Results

• 2 other identifiers: V251-0662006_023
• Study Type: interventional
• Target: 1,800
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis A; Measles; Mumps; Rubella; Chickenpox

Outcome Measures

Primary Outcomes (11)

• Participants With 1 or More Serious Vaccine-Related Adverse Experiences

  Days 1 to 14 after any vaccination

• Participants With 1 or More Injection-Site Adverse Experiences

  Days 1 to 14 after any vaccination

• Participants With Measles-Like Rash After First Vaccination

  Days 1 to 28 After First Vaccination

• Participants With Measles-Like Rash After Second Vaccination

  Days 1 to 28 After Second Vaccination

• Participants With Mumps-Like Symptoms After First Vaccination

  Days 1 to 28 After First Vaccination

• Participants With Mumps-Like Symptoms After Second Vaccination

  Days 1 to 28 After Second Vaccination

• Participants With Rubella-Like Rash After First Vaccination

  Days 1 to 28 After First Vaccination

• Participants With Rubella-Like Rash After Second Vaccination

  Days 1 to 28 After Second Vaccination

• Participants With Varicella/Zoster-Like Rash After First Vaccination

  Days 1 to 28 After First Vaccination

• Participants With Varicella/Zoster-Like Rash After Second Vaccination

  Days 1 to 28 After Second Vaccination

• Participants With Elevated Temperature (>=102.2F/39.0C)

  Days 1 to 5 After Any Vaccination

Secondary Outcomes (1)

• Participants With 1 or More Systemic Adverse Experiences

  Days 1 to 14 After Any Vaccination

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: vaccine

Biological: VAQTA®

2

ACTIVE COMPARATOR

Arm 2: Active comparator

Biological: VAQTA®; Biological: ProQuad

Interventions

VAQTA® BIOLOGICAL

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

Also known as: V251

1; 2

ProQuad BIOLOGICAL

0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

2

Eligibility Criteria

• Age: 12 Months - 17 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15.

  PMID: 30431383 BACKGROUND

MeSH Terms

Conditions

Hepatitis A; Measles; Mumps; Rubella; Chickenpox

Interventions

Hepatitis A Vaccines; measles, mumps, rubella, varicella vaccine

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 16, 2006
• Study Start: March 26, 2007
• Primary Completion: January 15, 2008
• Study Completion: January 15, 2008
• Last Updated: February 4, 2019
• Results First Posted: November 20, 2008

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share