Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup

Phase 3 Completed 1522 enrolled Novartis Novartis Vaccines · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV\_a in adults and elderly subjects.

Timeline

Start: 2007-10
Primary completion: 2008-06
Completion: 2008-06

Outcome

Mixed primary results

registry analysis (non-inferiority or equivalence test); FLU (cTIV or eTIV_a) + PV vs FLU (cTIV or eTIV_a); Ratio of GMTs 0.66 (95% CI 0.45 to 0.98) NCT00579345 ↗

registry analysis (non-inferiority or equivalence test); FLU (cTIV or eTIV_a) + PV vs FLU (cTIV or eTIV_a); Ratio of GMTs 0.81 (95% CI 0.55 to 1.19) NCT00579345 ↗

registry analysis (non-inferiority or equivalence test); FLU (cTIV or eTIV_a) + PV vs FLU (cTIV or eTIV_a); Ratio of GMTs 0.69 (95% CI 0.46 to 1.02) NCT00579345 ↗

Publications

Results Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Casula D, Sparacio M, Kovacs C, Groth N. Safety assessment and immunogenicity of a cell-culture-derived influenza vaccine in adults and elderly subjects over three successive influenza seasons. Hum Vaccin Immunother. 2012 May;8(5):645-52. doi: 10.4161/hv.19493. Epub 2012 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Optaflu(®)	Vaccine	0.5 ml	Intramuscular
Comparator	cTIV+PV OR eTIV_a+PV	Vaccine	—	—
Comparator	eTIV_a	Unknown	0.5 ml	Intramuscular