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 - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00312858

Purpose

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.

Condition	Intervention	Phase
Hepatitis A Virus	Biological: Comparator: VAQTA(R) Biological: Comparator: ProQuad(R) Biological: Comparator: Prevnar(R)	Phase III

MedlinePlus related topics: Chickenpox Hepatitis Hepatitis A Measles Mumps Rubella Shingles

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Hepatitis A Vaccines Chickenpox Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open, Randmzd., Multictr Study of the Safety, Tolerability, & Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Measles, Mumps, Rubella, & Varicella [Oka/Merck] Virus Vaccine Live & Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 Protein) in Healthy 12-Month-Olds

Further study details as provided by Merck:

Primary Outcome Measures:

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 [ Time Frame: 6 weeks post dose 1 & 4 weeks post dose 2 ] [ Designated as safety issue: No ]
Safety profile of concomitant use of hepatitis A vaccine with other study vaccines [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment:	653
Study Start Date:	April 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arm 1: VAQTA(R) 0.5 mL injection (2 doses 6 months apart), ProQuad(R) 0.5 mL injection (2 doses 6 months apart), Prevnar(R) 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.	Biological: Comparator: VAQTA(R) VAQTA(R) 0.5 mL injection Biological: Comparator: ProQuad(R) ProQuad(R) 0.5 mL injection Biological: Comparator: Prevnar(R) Prevnar(R) 0.5 mL injection
2: Active Comparator Arm 2: ProQuad(R) 0.5 mL injection (2 doses ~8 months apart), Prevnar(R) 0.5 mL injection (one dose), both administered concomitantly, VAQTA(R) 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.	Biological: Comparator: VAQTA(R) VAQTA(R) 0.5 mL injection Biological: Comparator: ProQuad(R) ProQuad(R) 0.5 mL injection

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

Ages Eligible for Study:	12 Months to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312858

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_075, V251-067
Study First Received:	April 7, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00312858
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Hepatitis A Virus

Study placed in the following topic categories:

Herpes Zoster
Liver Diseases
Measles
Picornaviridae Infections
Chickenpox
Hepatitis, Viral, Human
Healthy
Diphtheria

Rubella
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis A
Chicken pox
Enterovirus Infections
Mumps

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009