Phase 2
N=979
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Pandemic H5N1 Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01776541 ↗Enrolled (actual)
979
Serious AEs
2.9%
Results posted
Feb 2015
Primary outcome: Primary: Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. — 4; 4; 85; 63 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adjuvanted H5N1 pandemic influenza vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. |
4; 4; 85; 63 | — |
| PRIMARY Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. |
48; 27; 83; 61; 22; 9 | — |
| PRIMARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. |
322; 236; 4; 0; 54; 35 | — |
| PRIMARY Number of Subjects Reporting Unsolicited AEs After Any Vaccination. |
94; 92; 39; 31; 20; 8 | — |
| SECONDARY Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. |
5.37; 2.43; 41; 11; 1.95; 1.24 | — |
| SECONDARY Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. |
4; 4; 52; 30; 85; 63 | — |
| SECONDARY Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. |
48; 27; 83; 61; 22; 9 | — |
Summary
Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
Eligibility Criteria
Inclusion Criteria
- Healthy adult subjects 18 to 64 years of age,
- Individuals willing to provide written informed consent,
- Individuals in good health,
- Individuals willing to allow for their serum samples to be stored beyond the study period.
Exclusion Criteria
- Individuals not able to understand and follow study procedures,
- History of any significant illness,
- History of any chronic medical condition or progressive disease,
- Presence of medically significant cancer,
- Known or suspected impairment/alteration of immune function,
- Presence of any progressive or severe neurologic disorder,
- Presence of any bleeding disorders or conditions that prolongs bleeding time,
- History of allergy to vaccine components,
- Receipt of any other investigational product within 30 days prior to entry into the study,
- History of previous H5N1 vaccination,
- Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
- Receipt of any other vaccine within 2 weeks prior to entry into the study
- Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
- Pregnant or breast feeding,
- Females of childbearing potential refusing to use acceptable method of birth control,
- Body mass index (BMI) ≥ 35 kg/m2,
- History of drug or alcohol abuse,
- Any planned surgery during study period,
- Individuals conducting the study and their immediate family members,
- Individuals with behavioral or cognitive impairment or psychiatric diseases.
Data sourced from ClinicalTrials.gov (NCT01776541). 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.