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Completed

NCT Number: NCT00326183

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

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.

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Key information

Conditions

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

Age range

12 month–17 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VAQTA®

Biological

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

Other names: V251

ProQuad

Biological

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

Primary outcomes

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

    Time frame: Days 1 to 14 after any vaccination

  2. Participants With 1 or More Injection-Site Adverse Experiences

    Time frame: Days 1 to 14 after any vaccination

  3. Participants With Measles-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  4. Participants With Measles-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  5. Participants With Mumps-Like Symptoms After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  6. Participants With Mumps-Like Symptoms After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  7. Participants With Rubella-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  8. Participants With Rubella-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

  9. Participants With Varicella/Zoster-Like Rash After First Vaccination

    Time frame: Days 1 to 28 After First Vaccination

  10. Participants With Varicella/Zoster-Like Rash After Second Vaccination

    Time frame: Days 1 to 28 After Second Vaccination

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

    Time frame: Days 1 to 5 After Any Vaccination

Secondary outcomes

  1. Participants With 1 or More Systemic Adverse Experiences

    Time frame: Days 1 to 14 After Any Vaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 16, 2006
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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