GSK’s Quadrivalent Flu Vaccine Reported Successful in Clinical Study

A Phase 3 clinical trial assessing the efficacy of Fluarix Tetra, which is an inactivated quadrivalent influenza vaccine, in children aged six to 35 months met the two primary endpoints.

A quadrivalent inactivated vaccine (QIV) offers protection against two influenza A strains and two influenza B strains, therefore considerably reducing chances of mismatch between the vaccine strains and the circulating strains.

Currently, Fluarix Tetra is approved by 30 countries, and more than 100 million doses have been distributed since 2013.

This study reported 63.2 percent of children receiving Fluarix Tetra were protected against laboratory-confirmed, moderate-to-severe influenza, while 49.8 percent were protected against influenza of any severity.

In culture-confirmed influenza strains that matched the vaccine strains, the efficacy of Fluarix Tetra was 77.6% and 60.1%, respectively.

The safety profile of the IIV4 was comparable with that of the non-influenza control vaccine.

The IIV4 clinical study’s results showed that children receiving the Fluarix Tetra vaccine:

• utilized fewer healthcare services and maintained their daily activities,
• reducing by half the need for doctor visits,
• antibiotics shouldn't be used,
• Minimized parental work absence.

Thomas Breuer, Chief Medical Officer, GSK Vaccines, said: “This study is the first randomized clinical trial designed to evaluate vaccine efficacy for a Quadrivalent influenza vaccine in young children.”

The study was conducted in five independent cohorts between October 2011 and December 2014 and enrolled 12,018 subjects in 13 countries from Europe, Central America and Asia during the 2011-2012 and 2012-2013 Northern Hemisphere influenza seasons, and from 2012 to 2014 during influenza seasons in subtropical countries to provide robust data on vaccine efficacy.

The World Health Organization has recently highlighted that for the 2017/18 season, QIVs can be expected to provide wider protection against influenza B virus infections than trivalent inactivated vaccines (TIVs) which only contain one B strain instead of two.

In the USA, the 2017-2018 flu vaccination effectiveness (VE) was reported to be just 36 percent effective.

Annual revaccination with Fluarix Tetra is recommended because immunity declines during the year after vaccination and because circulating strains of influenza virus might change from year to year.

Fluarix Tetra should not be administered to subjects with known hypersensitivity after previous administration of influenza vaccines (including Fluarix Tetra) or to any component of the vaccine.

Vaccination with Fluarix Tetra should be postponed in subjects suffering from an acute illness with moderate to high fever. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

Flu vaccines are still available at most pharmacies offering several FDA approved flu vaccines.

The CDC Vaccine Price List provides the private sector prices for general information.

Flu vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.