This multicenter randomized, controlled, double-blind Phase 1 trial investigated the safety, tolerability, immunogenicity, and feasibility of adding an adjuvant to an influenza vaccine at point-of-use (commonly referred to as the Mix-N-Match study). Inactivated influenza A/Indonesia/05/2005 virus vaccine and the adjuvant, AS03, were provided by the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) from the National Prepandemic Influenza Vaccine Stockpile. 225 subjects completed the regimen of receiving 2 intramuscular doses of vaccine spaced 21 days apart at either 3.75, 7.5, or 15 mcg of hemagglutinin. The AS03 adjuvant or a phosphate-buffered saline diluent was added immediately prior to injection. This dataset includes: a) serum hemagglutination inhibition (HAI) and microneutrilization (MN) antibody assessment values taken on days 0 (prevaccination), 8, 21 (before second dose), and 42; b) clinical safety hematology and chemistry laboratory values collected before and 8 days subsequent to each vaccination; and, c) clinical reactogenicity and adverse event data.

The research associated with this dataset is an extension of a multicenter randomized, controlled, double-blind phase 1 trial that investigated combining an adjuvant (AS03) with an influenza (A/H5N1) vaccine at point-of-use (see “Related Datasets” below). In the original study adult volunteers were given 2 intramuscular doses of vaccine containing 3.75, 7.5, or 15 mcg of hemagglutinin (HA) with or without adjuvant spaced 21 days apart. Serum samples were taken at 4 intervals ending with day 42 after vaccination. This research assessed the kinetics of antibody responses by analyzing samples taken at day 201 (6 months) and 386 (12 months) postvaccination. Hemagglutination inhibition (HAI) and microneutrilization (MN) responses were evaluated for the homologous virus (A/Indonesia/05/2005) as well as the heterologous virus strains A/Vietnam/1203/2004, A/Anhui/01/2005, A/turkey/Turkey/01/2005, and A/Hubei/1/2010. This dataset includes HAI and MN antibody assessment values for the 3 different doses with and without adjuvant for the homologous virus as well as the 4 drift virus strains.

Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. Completeness of relevant parts of the CSRs was determined via an extraction form based on the CONSORT statement checklist. Authors have provided the full set of clinical study reports for both medications provided to the Cochrane collaboration by Roche, GlaxoSmithKline, and the European Medicines Agency (EMA) for use in the systematic review of these neuraminidase inhibitors for treating/preventing influenza in healthy adults and children. A guest post on the "Dryad News and Views" site regarding the dataset of clinical study reports and the resulting Cochrane systematic review is available at: https://blog.datadryad.org/2014/04/17/tamiflu-data/