| 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 ]
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| 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 |
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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 |
| 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. |
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| 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
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- 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
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| 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
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| Both |
| 12 Months to 17 Months |
| Yes |
| Contact: Toll Free Number |
1-888-577-8839 |
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| United States |
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| NCT00289913 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2005_076 |
| Merck |
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| Study Director: |
Medical Monitor |
Merck |
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| Merck |
| November 2009 |