Status:
COMPLETED
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 (V251-068)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis A Virus
Eligibility:
All Genders
12-17 years
Phase:
PHASE4
Brief Summary
This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Va...
Detailed Description
In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated. In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was colle...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1274 Patients enrolled
Trial Details
Trial ID
NCT00289913
Start Date
April 1 2006
End Date
June 1 2010
Last Update
April 13 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.