Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Patients Treated with Palbociclib for Advanced Breast Cancer in Australia (PIPPA)

Start Date19 Sep 2022

Sponsor / Collaborator

Pfizer Australia Pty Ltd.

ACTRN12621000173897 / RecruitingPhase 4

STOPit: Study of TOfacitinib for the treatment of chronic PouchITis

Start Date16 Jul 2021

Sponsor / Collaborator

Pfizer Australia Pty Ltd.

100 Clinical Results associated with Pfizer Australia Pty Ltd.

0 Patents (Medical) associated with Pfizer Australia Pty Ltd.

Literatures (Medical) associated with Pfizer Australia Pty Ltd.

15 May 2024·Clinical Infectious Diseases

Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults

Article

Author: Voloshyna, Olga ; Argent, Christopher ; Russo, Marc ; Anderson, Annaliesa S ; Bird, Paul ; Lickliter, Jason ; O'Sullivan, Matthew ; Leelasena, Indika ; Gunner, Elizabeth ; Hiew, Valerie ; Murdoch, Louise ; Bloch, Mark ; Jiang, Qin ; Bull, Sheetal ; Tai, Sze ; De Silva, Gustinna ; Gilfillan, Christopher ; Gurtman, Alejandra ; Ryan, Philip ; Swanson, Kena A ; Jaques, Anna ; Tiong, Florence ; Neville, A Munro ; Deshmukh, Sachin ; Kalinina, Elena V ; Mohan, Rahul ; Scott, Robert ; Baber, James ; Quan, Karen ; Eizenberg, Peter ; Scott, Robert J ; Colquhoun, David ; Athan, Eugene ; Nelson, Mark ; Arya, Mark ; Cutler, Mark W ; Li, Wen ; McGirr, Anthony ; Rook, Christopher ; Schmoele-Thoma, Beate ; Morbey, Claire ; Gruber, William C ; Cooper, David ; Wark, Peter ; Leah, Amber

AbstractBackgroundRespiratory syncytial virus (RSV) and influenza are both typically seasonal diseases, with winter peaks in temperate climates. Coadministration of an RSV vaccine and influenza vaccine could be a benefit, requiring 1 rather than 2 visits to a healthcare provider for individuals receiving both vaccines.MethodsThe primary immunogenicity objective of this phase 3, 1:1 randomized, double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia was to demonstrate noninferiority of immune responses with coadministration of the stabilized RSV prefusion F protein–based vaccine (RSVpreF) and seasonal inactivated influenza vaccine (SIIV) versus SIIV or RSVpreF administered alone, using a 1.5-fold noninferiority margin (lower bound 95% confidence interval >.667). Safety and tolerability were evaluated by collecting reactogenicity and adverse event data.ResultsOf 1403 participants randomized, 1399 received vaccinations (median age, 70; range, 65‒91 years). Local reactions and systemic events were mostly mild or moderate when RSVpreF was coadministered with SIIV or administered alone. No vaccine-related serious adverse events were reported. Geometric mean ratios were 0.86 for RSV-A and 0.85 for RSV-B neutralizing titers at 1 month after RSVpreF administration and 0.77 to 0.90 for strain-specific hemagglutination inhibition assay titers at 1 month after SIIV. All comparisons achieved the prespecified 1.5-fold noninferiority margin.ConclusionsThe primary study objectives were met, demonstrating noninferiority of RSVpreF and SIIV immune responses when RSVpreF was coadministered with SIIV and that RSVpreF had an acceptable safety and tolerability profile when coadministered with SIIV. The results of this study support coadministration of RSVpreF and SIIV in an older-adult population.Clinical Trials Registrationhttps://clinicaltrials.gov/study/NCT05301322.

01 Nov 2023·BMJ Open

Estimating the cost and epidemiology of mild to severe chronic pain associated with osteoarthritis in England: a retrospective analysis of linked primary and secondary care data

Article

Author: Clewes, Peter ; Coates, Greg ; Walsh, David ; Stevenson, Hannah ; Tritton, Theo ; Wood, Robert ; Dickson, Alastair J ; Lohan, Christoph ; Knaggs, Roger ; Massey, Lucy

ObjectiveOsteoarthritis (OA) affects 10% of adults in the UK. Despite over one-third of people with OA experiencing chronic pain, few studies have examined the population-level impact of chronic pain associated with OA. We compared resource-use and epidemiological outcomes in patients with mild, moderate and severe chronic OA-associated pain and matched controls without known OA.DesignRetrospective, longitudinal, observational cohort study (July 2008 to June 2019).SettingElectronic records extracted from Clinical Practice Research Datalink GOLD primary care linked to Hospital Episode Statistics (HES).ParticipantsPatients (cases; n=23 016) aged ≥18 years with chronic OA-associated pain. Controls (n=23 016) without OA or chronic pain matched on age, sex, comorbidity burden, general practitioner practice and available HES data.InterventionsNone.Primary and secondary outcome measuresTotal healthcare resource use (HCRU), direct healthcare costs in 0–12, 12–24 and 24–36 months postindex. Secondary outcomes included incidence and prevalence of chronic OA-associated pain and pharmacological management.ResultsHCRU was consistently greater in cases versus controls for all resource categories during preindex and postindex periods. Across follow-up periods, resource use was greatest in patients with severe pain. In the first 12 months postindexing, mean total costs incurred by cases were four times higher versus matched controls (£256 vs £62); costs were approximately twice as high in cases vs controls for months 12–24 (£166 vs £86) and 24–36 (£150 vs £81; all p<0.0001). The incidence of new cases of chronic pain associated with OA was 2.64 per 1000 person-years; the prevalence was 1.4%.ConclusionsThis study highlights the real-world cost of chronic pain associated with OA in cases versus matched controls. We included patients with mild, moderate and severe pain associated with OA, and showed HCRU in discrete 1-year time frames. The true economic burden of pain associated with OA is likely to be considerably higher when indirect costs are considered.

01 Sep 2023·Infectious diseases and therapy

Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults.

Article

Author: Baber, James A ; Türeci, Özlem ; Quan, Karen ; Zhang, Ying ; Anderson, Annaliesa S ; Lockhart, Stephen P ; Swanson, Kena A ; Lu, Claire ; Şahin, Uğur ; Gruber, William C ; Kitchin, Nicholas ; Koury, Kenneth ; Xu, Xia ; Murdoch, Louise ; Ho, Agnes W Y ; Cooper, David

INTRODUCTIONVaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial benefits, including streamlining vaccine delivery.METHODSIn this phase 3 study, healthy 18- to 64-year-olds who had received three previous doses of BNT162b2 were randomized (1:1) to the coadministration group (month 0, BNT162b2 + SIIV; month 1, placebo) or the separate-administration group (month 0, placebo + SIIV; month 1, BNT162b2). The primary immunogenicity objective was to demonstrate that the immune responses elicited by BNT162b2 and SIIV [measured by full-length S-binding immunoglobulin G (IgG) levels and strain-specific hemagglutination inhibition assay (HAI) titers against four influenza strains 1 month post-vaccination, respectively] when coadministered were noninferior to those elicited by either vaccine administered alone, based on a prespecified 1.5-fold noninferiority margin [lower bound 95% CI for geometric mean ratio (GMR) > 0.67]. Reactogenicity and adverse event (AE) rates were evaluated.RESULTSRandomized participants who received study vaccination (N = 1128; coadministration group, n = 564; separate-administration group, n = 564) had a median age of 39 years. Model-adjusted GMRs for coadministration to separate administration were 0.83 (95% CI 0.77, 0.89) for full-length S-binding IgG levels and 0.89-1.00 (lower bound of all 95% CIs > 0.67) for the four influenza strain-specific HAI titers, with all endpoints achieving the prespecified noninferiority criterion. Reactogenicity events were mostly mild or moderate when BNT162b2 was coadministered with SIIV. Serious AEs were reported in < 1% of participants within 1 month after any vaccination; none were considered vaccine-related.CONCLUSIONSBNT162b2 coadministered with SIIV elicited immune responses that were noninferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults.TRIAL REGISTRATIONClinicalTrials.gov registration: NCT05310084.

100 Deals associated with Pfizer Australia Pty Ltd.

100 Translational Medicine associated with Pfizer Australia Pty Ltd.

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