Target influenza with Supemtek▼(Quadrivalent Influenza Vaccine, recombinant, prepared in cell culture), the first recombinant influenza vaccine in Europe, indicated for active immunisation for the prevention of influenza disease in adults.1 Supemtek is manufactured to offer an exact genetic match to the WHO-predicted viral strains haemagglutinin antigen.1,2
Supemtek has shown 30% greater relative efficacy (1% absolute efficacy) against influenza-like illness versus standard-dose egg-based quadrivalent influenza vaccine (QIVe) (2.2% vs 3.2% influenza attack rate) in adults aged 50+ years (Figure 1).1,2
A randomised, controlled trial of 8,604 adults aged 50+ years during the 2014/15 influenza season found that Supemtek showed 30% greater relative efficacy (1% absolute efficacy; 2.2% vs 3.2% influenza attack rate) against influenza-like illness (reverse-transcriptase polymerase chain-reaction [RT-PCR] confirmed) versus standard-dose QIVe (95% confidence interval [CI]: 10–47).1,2
RT-PCR-confirmed influenza-like illness (primary endpoint) attack rates were 3.2% (138 infections) and 2.2%
(96 infections) with standard-dose QIVe and Supemtek, respectively.1,2
Additionally, when considering the secondary endpoint, culture-positive influenza-like illness, Supemtek showed 43% greater relative protection compared with standard-dose QIVe. Culture-positive influenza-like illness attack rates were 2.3% (101 infections) and 1.3% (58 infections) for standard-dose QIVe and Supemtek, respectively.1,2
Figure 1: Supemtek showed greater relative efficacy against influenza than standard-dose QIVe in adults aged 50+ years.1,2
*Relative vaccine efficacy (rVE) of Supemtek vs standard-dose QIVe. †Lower bound (LB) of 95% CI interval met pre-specified, exploratory criterion for superior relative vaccine efficacy, LB >9%. Relative risk is calculated as percentage of participants with documented flu in the Supemtek group (Supemtek attack rate) divided by percentage of participants with documented flu in the QIVe group (QIVe attack rate). rVE is calculated as 100x (1 - relative risk).
Supemtek showed comparable immunogenicity to standard-dose QIVe in adults aged 18–49 years.1,3
Comparison of immunogenicity with Supemtek or QIVe during the 2014/15 influenza season was tested according to co-primary endpoints, geometric mean antibody titres (GMT) (Table 1) and seroconversion rates (SCR) (Table 2) at Day 28, across influenza strains in a randomised, controlled trial of 1,350 adults.1,3
Supemtek responses to three of the four influenza strains (A/H1N1, A/H3N2 and B/Massachusetts) met
non-inferiority criteria. Supemtek responses to B/Brisbane/60/2008 did not meet non-inferiority criteria; however, responses were low in both groups so comparisons could not be drawn.1,3
Table 1: Day 28 GMTs in patients aged 18–49 years.1
Non-inferiority for haemagglutination inhibition (HAI) SCRs and post-vaccination GMT ratios for each antigen were co-primary endpoints. Success in meeting GMT non-inferiority endpoint was pre-defined as an upper bound (UB) of the two-sided 95% CI of GMT QIVe/GMT Supemtek <1.5.
Table 2: Day 28 SCRs in patients aged 18–49 years.1
Non-inferiority for HAI SCRs and post-vaccination GMT ratios for each antigen were co-primary endpoints. Success in meeting SCR non-inferiority endpoint was pre-defined as an UB of the two-sided 95% CI of SCR QIVe/SCR Supemtek ≤10%.
A/H3N2 GMT ratios between vaccines met non-inferiority criteria in both age groups (Figure 2).1–3
Figure 2: GMT ratios between vaccines in 50+ and 18–49 age groups.1–3
*Success in meeting GMT endpoint was pre-defined as an UB of the two-sided 95% CI of GMT standard-dose QIVe/GMT Supemtek <1.5.
People who received Supemtek showed increased antibody titres against A/H3N2 at Day 28 compared with those who received standard-dose QIVe1–3
SUPEMTEK SAFETY PROFILE
In two separate studies of adults aged 50+ years and 18–49 years, Supemtek showed a comparable safety profile to standard-dose QIVe (Figure 3 and 4).2,3
The most commonly reported reactions after vaccine administration were injection-site reactions (tenderness and pain). Severity of reactions were mild to moderate. Onset usually occurred within the first 3 days after vaccination. All reactions resolved without sequelae.1
Figure 3: Adverse events reported in 50+ age group occurring in ≥2% of participants.2
*Events listed are those that occurred in ≥2% of participants in either treatment group. †The reactogenicity population comprised all vaccinated participants who recorded reactogenicity data at least once within 7 days after vaccination.
Figure 4: Adverse events reported in 18–49 age group occurring in ≥1% of participants.3
*Events listed are those that occurred in ≥1% of participants in either treatment group. †The reactogenicity population comprised all vaccinated participants who recorded reactogenicity data at least once within 7 days after vaccination.
AE, adverse event; CI, confidence interval; GMT, geometric mean titre; HAI, haemagglutination inhibition; LB, lower bound; QIVe, quadrivalent inactivated influenza; RT-PCR, reverse-transcriptase polymerase chain-reaction; rVE, relative vaccine efficacy; UB, upper bound.
|Reporting side effects
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Sanofi drug safety department on 0800 0902 314. Alternatively send via email to
Date of preparation: March 2021 | MAT-GB-2003352(v1.0)