Phase 2 N=1,393 Randomized Double-blind Prevention

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Pandemic H5N1 Influenza

Bottom Line

View on ClinicalTrials.gov: NCT01766921 ↗

Enrolled (actual)

1,393

Serious AEs

6.8%

Results posted

Aug 2015

Primary outcome: Primary: The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. — 12; 10; 81; 63 Percentages of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Adjuvanted H5N1 pandemic influenza vaccine (Biological)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.	12; 10; 81; 63	—
PRIMARY The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.	74; 52	—
PRIMARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.	314; 212; 17; 5; 20; 11	—
PRIMARY Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.	147; 149; 56; 61; 101; 123	—
SECONDARY Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.	3.21; 2.01; 16; 5.72; 1.97; 1.3	—
SECONDARY Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain	12; 10; 49; 32; 81; 63	—
SECONDARY The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain	36; 21; 74; 52; 23; 10	—

Summary

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

Eligibility Criteria

Inclusion Criteria

Healthy elderly subjects ≥65 years,
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 serious 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,
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01766921). 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.