Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella, and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month Old Children
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A
Intervention: VAQTA® (Biological); ProQuad® (Biological); Prevnar® (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and
varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together
with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose.
Immunogenicity and safety data will be collected after each dose of vaccine.
Clinical Details
Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Measles, Mumps, Rubella, and Varicella [Oka/Merck] Virus Vaccine Live and Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 Protein) in Healthy Children 12 Months of Age
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Antibody responses to hepatitis A (4 weeks post dose 2), varicella (6 weeks post dose 1), and S. pneumoniae (6 weeks post vaccination)Safety profile of concomitant use of hepatitis A vaccine with other study vaccines
Detailed description:
Vaccines: V251, Hepatitis A Vaccine, Inactivated administered with Measles, Mumps, Rubella
and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine will have a Duration of
Treatment: 2 Doses, 6 months apart.
Vaccine: Hepatitis A Vaccine, Inactivated, administered alone will have a Duration of
Treatment: 2 Doses, 6 months apart.
Eligibility
Minimum age: 12 Months.
Maximum age: 15 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 12- to 15-month-old males and females with no active liver disease
- A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster
Exclusion Criteria:
- Males and females previously vaccinated with hepatitis A, measles, mumps, rubella,
and/or chickenpox vaccine
- Any immune deficiency
- History of allergy to any of the vaccine components
- History of any seizure disorder
Locations and Contacts
Additional Information
Starting date: April 2006
Ending date: March 2008
Last updated: December 20, 2007
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