Clinical Trials Logo
  1. Home
  2. Pandemic Influenza
  3. NCT00971542

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

Pandemic Influenza Clinical Trial

Official title:
A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

Clinical Trial Summary

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00971542
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date September 2009
Completion date July 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT00976469 - A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents Phase 1/Phase 2
Completed NCT00535665 - Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine Phase 2
Completed NCT00950456 - Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine N/A
Completed NCT00908687 - A/H5N1/LT Dose Ranging Study Phase 2
Completed NCT00783926 - Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant) Phase 1
Completed NCT00519389 - Safety, Reactogenicity and Immunogenicity of an H5N1 VLP Phase 1/Phase 2
Recruiting NCT06046092 - H7HLAII DNA Influenza Vaccine Phase 1
Completed NCT01640691 - Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults Phase 1/Phase 2
Completed NCT01053143 - Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India Phase 3
Completed NCT00457509 - Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults Phase 1
Completed NCT00660257 - Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine Phase 1
Completed NCT00959465 - A/H1N1 Immunogenicity and Safety in Adults Phase 1/Phase 2
Completed NCT00971100 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age Phase 3
Completed NCT00970177 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age Phase 3
Completed NCT00971906 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age Phase 3
Completed NCT00532792 - A/H5N1 Dose Ranging Study With Adjuvant Patch Phase 1
Withdrawn NCT00640211 - A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B N/A
Withdrawn NCT00640302 - A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza N/A
Withdrawn NCT00640874 - A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza N/A