Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults

NCT02600585 | Completed

• 1 other identifier: PSC13
• Study Type: observational
• Target: 254,648
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).

Conditions

Human Influenza

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)

  Incidence of Serious and/or Medically-Attended Adverse events

  Five months post-vaccination

Study Arms (2)

Flublok

Recombinant influenza vaccine (RIV); Intramuscular injection of vaccine of recombinant uncleaved hemagglutinin (rHA0) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL.

Biological: Recombinant Influenza Vaccine

Inactivated Influenza Vaccine

Injectable, inactivated, egg-based influenza vaccines (IIV); Intramuscular injection of vaccine (whether trivalent or quadrivalent) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL.

Biological: Inactivated Influenza Vaccine

Interventions

Recombinant Influenza Vaccine BIOLOGICAL

Intramuscular injection of study vaccine

Also known as: Flublok

Flublok

Inactivated Influenza Vaccine BIOLOGICAL

Intramuscular injection of study vaccine

Inactivated Influenza Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include adults 18 years of age and older who are vaccinated with either Flublok or IIV within the same time period, e.g. month of the year.

You may qualify if:

• Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.

Sponsors & Collaborators

• Protein Sciences Corporation: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

FluBlok

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Roger Baxter, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

US (1)