Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
Launched by GLAXOSMITHKLINE · May 8, 2006
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Healthy male or female between, and including, 13 and 14 months of age
- • Having participated in the primary vaccination study 217744/097.
- Exclusion criteria:
- • Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
- • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- • A family history of congenital or hereditary immunodeficiency
- • History of any neurologic disorders or seizures
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Madrid, , Spain
Palma De Mallorca, , Spain
Alcorcon, , Spain
Malaga, , Spain
Móstoles/Madrid, , Spain
Getafe, , Spain
Burgos, , Spain
Velez, Malaga, , Spain
Basurto/Bilbao, , Spain
Valladolid, , Spain
Almeira, , Spain
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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