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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.
Study NCT00289913   Information provided by Merck
First Received: February 8, 2006   Last Updated: November 5, 2009   History of Changes

February 8, 2006
November 5, 2009
April 2006
January 2011   (final data collection date for primary outcome measure)
  • Antibody response of hepatitis A [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: No ]
  • Antibody response to Hib and antibody titers for pertussis [ Time Frame: 4 weeks post vaccination ] [ Designated as safety issue: No ]
  • Safety profile of Hepatitis A Vaccine, Inactivated with other vaccines. Safety profile of Hepatitis A Vaccine, Inactivated after any dose [ Time Frame: 14 days following vaccination ] [ Designated as safety issue: Yes ]
Antibody responses of hepatitis A (4 weeks postdose 2), Hib (4 weeks postvaccination), and pertussis (4 weeks postvaccination). Safety profile of Hepatitis A Vaccine, Inactivated with other vaccines.
Complete list of historical versions of study NCT00289913 on ClinicalTrials.gov Archive Site
 
 
 
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
Open, Rand., Multictr. Study of Safety, Tolerability, & Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate), Diphtheria, Tetanus Toxoids, and Acellular Pertussis Vaccine Adsorbed in Healthy Children 15 Mos. Old

Stage 1: Hepatitis A vaccine will be given either alone or together with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine or Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) at the first dose. A second dose of hepatitis A vaccine will be given 6 months later. Responses to the vaccines and safety data will be collected after each dose. Stage 2: Two (2) doses Hepatitis A vaccine will be administered at least 6 months apart. Safety data will be collected after each dose.

 
Phase III
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Hepatitis A Virus
  • Biological: Comparator: Vaqta
  • Biological: Comparator: Infanrix
  • Biological: Comparator: PedvaxHIB
  • Experimental: VAQTA 0.5 ml injection, Infanrix 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection
  • Experimental: Infanrix 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection, VAQTA 0.5 ml injection
  • Experimental: VAQTA 0.5 ml injection, PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection
  • Experimental: PedvaxHIB 0.5 ml injection, VAQTA 0.5 ml injection, VAQTA 0.5 ml injection
  • Experimental: VAQTA 0.5 ml injection, VAQTA 0.5 ml injection
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1270
April 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stage 1) 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
  • Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A

Exclusion Criteria:

  • Stage 1) 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 neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
  • Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder
Both
12 Months to 17 Months
Yes
Contact: Toll Free Number 1-888-577-8839
United States
 
NCT00289913
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
2005_076
Merck
 
Study Director: Medical Monitor Merck
Merck
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP