Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00326183
First received: May 12, 2006
Last updated: February 19, 2009
Last verified: January 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
  • Participants With 1 or More Injection-Site Adverse Experiences [ Time Frame: Days 1 to 14 after any vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Measles-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Measles-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Mumps-Like Symptoms After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Mumps-Like Symptoms After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Rubella-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Rubella-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Varicella/Zoster-Like Rash After First Vaccination [ Time Frame: Days 1 to 28 After First Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Varicella/Zoster-Like Rash After Second Vaccination [ Time Frame: Days 1 to 28 After Second Vaccination ] [ Designated as safety issue: Yes ]
  • Participants With Elevated Temperature (>=102.2F/39.0C) [ Time Frame: Days 1 to 5 After Any Vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Participants With 1 or More Systemic Adverse Experiences [ Time Frame: Days 1 to 14 After Any Vaccination ] [ Designated as safety issue: Yes ]

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
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 Names:
  • V251
  • VAQTA®
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 Names:
  • V251
  • VAQTA®
Biological: ProQuad
0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
Other Name: ProQuad

  Eligibility

Ages Eligible for Study:   12 Months to 17 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00326183     History of Changes
Other Study ID Numbers: 2006_023, V251-066
Study First Received: May 12, 2006
Results First Received: October 21, 2008
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Hepatitis
Hepatitis A
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on August 21, 2014