Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age

This study is currently recruiting participants.

Verified by Merck, April 2009

First Received: February 8, 2006 Last Updated: April 1, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00289913

Purpose

Hepatitis A vaccine will be given either alone or together with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine at the first dose. A second dose of hepatitis A vaccine will be given 6 months later. Response to the vaccines and safety data will be collected after each dose.

Condition	Intervention	Phase
Hepatitis A	Biological: VAQTA® Biological: Infanrix® Biological: PedvaxHIB®	Phase III

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis A Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed in Healthy Children 15 Months of Age

Further study details as provided by Merck:

Primary Outcome Measures:

Antibody response of hepatitis A (4 weeks post dose 2), Hib (4 weeks postvaccination), and pertussis (4 weeks postvaccination). Safety profile of Hepatitis A Vaccine, Inactivated with other vaccines [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	620
Study Start Date:	April 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Arm 1: VAQTA® 0.5 ml injection, Infanrix® 0.5 ml injection, PedvaxHIB® 0.5 ml injection; VAQTA® 0.5 ml injection	Biological: VAQTA® VAQTA® 0.5 ml injection Biological: Infanrix® Infanrix® 0.5 ml injection Biological: PedvaxHIB® PedvaxHIB® 0.5 ml injection
2 Arm 2: Infanrix® 0.5 ml injection, PedvaxHIB® 0.5 ml injection; VAQTA® 0.5 ml injection; VAQTA® 0.5 ml injection	Biological: VAQTA® VAQTA® 0.5 ml injection Biological: Infanrix® Infanrix® 0.5 ml injection Biological: PedvaxHIB® PedvaxHIB® 0.5 ml injection

Eligibility

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

Criteria

Inclusion Criteria:

Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases.

Exclusion Criteria:

Males and females previously vaccinated with hepatitis A vaccine
Any immune deficiency
A history of allergy to any of the vaccine components
A history of seizure disorder, or a bleeding disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289913

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 36 Study Locations

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional 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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_076, V251-068
Study First Received:	February 8, 2006
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00289913 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Hepatitis A virus

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Whooping Cough
Hepatitis, Viral, Human
Picornaviridae Infections
Healthy
Diphtheria

Tetanus
Hepatitis
Virus Diseases
Gram-Positive Bacterial Infections
Digestive System Diseases
Hepatitis A
Enterovirus Infections

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Liver Diseases
Hepatitis, Viral, Human
Picornaviridae Infections
Diphtheria
Actinomycetales Infections

Hepatitis
Virus Diseases
Gram-Positive Bacterial Infections
Digestive System Diseases
Corynebacterium Infections
Hepatitis A
Enterovirus Infections

ClinicalTrials.gov processed this record on May 07, 2009