Phase 3
N=1,893
Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00464672 ↗Enrolled (actual)
1,893
Serious AEs
1.0%
Results posted
May 2010
Primary outcome: Primary: Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age — 93; 96; 91; 99 Percentages of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Influenza virus vaccine (Biological); Comparator influenza vaccine (Biological)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age |
93; 96; 91; 99; 100; 86 | — |
| PRIMARY Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age |
74; 72; 77; 86; 89; 74 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age |
161; 89; 27; 12; 38; 24 | — |
| SECONDARY Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age |
99; 100; 93; 98; 100; 89 | — |
| SECONDARY Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age |
92; 67; 81; 91; 92; 73 | — |
| SECONDARY Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age |
960; 493; 144; 1246; 1463; 114 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age |
134; 62; 7; 3; 28; 13 | — |
| SECONDARY Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age |
97; 100; 85; 99; 99; 81 | — |
| SECONDARY Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age |
95; 86; 83; 97; 95; 79 | — |
| SECONDARY Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age |
625; 710; 157; 716; 1472; 126 | — |
| SECONDARY Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. |
92; 56; 66; 39; 9; 5 | — |
| SECONDARY Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age |
244; 219; 126; 512; 485; 104 | — |
Summary
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects 3 to 64 years of age
Exclusion Criteria
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
Data sourced from ClinicalTrials.gov (NCT00464672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.