Supplemental Digital Content 1: Study characteristics of the three included GSK pediatric studies of trivalent influenza vaccine in children.

Supplemental Digital Content 1: Study characteristics of the three included GSK pediatric studies of trivalent influenza vaccine in children.

Author ClinicalTrials.gov identifier

Age ranges Study groups Number of

participants enrolled

Vaccine strains Length of monitoring for solicited adverse events

Definition of Fever

Pavia-Ruz

(2013)¹⁰ NCT00764790 6-35 months

1. 0.25mL Fluarix (GSK) 2. 0.25mL Fluzone

(Sanofi)

3. 0.5mL Fluarix (GSK) 3317

H1N1: A/Brisbane/59/2007 H3N2: A/Uruguay/716/2007 B: B/Brisbane/3/2007^§ B: B/Florida/4/2006

4 days (0-3)

≥38.0°C axillary/oral

≥38.5°C rectal

Domachowske

(2012)¹² NCT00980005

3-4 years 5-8 years 9-17years

1. Flulaval (GSK) 2. Comparator vaccine

2128

2009-2010 Northern Hemisphere

H1N1: A/Brisbane/59/2007 H3N2: A/Uruguay/716/2007 B: B/Brisbane/60/2008

4 days (0-3) ≥38°C oral

Baxter (2010)¹¹ NCT00383123

6 months - 5 years (immunogenicity subset)

6 months -17 years (safety subset)

1. Fluarix (GSK) 2. Fluzone (Sanofi)

3327

(immunogenicity subset n=871)

2006-2007 season

H1N1: A/New Caledonia/20/99 H3N2: A/Wisconsin/67/2005 B: B/Malaysia/2506/2004.

4 days (0-3) ≥37.5°C. No source mentioned

§B/Brisbane/3/2007 was a B/Florida/4/2006-like strain used in the GSK vaccine. B/Florida/4/2006 was used in the Sanofi vaccine.