scholarly journals Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety and Tolerability of BNO 1030 application in the technology of delayed prescription of antibiotics in patients with severe acute tonsillitis

2021 ◽  
Author(s):  
V. I. Popovych ◽  
I. V. Koshel ◽  
O. N. Malofiichuk ◽  
L. I. Pyletska ◽  
O. A. Semeniuk ◽  
...  
Keyword(s):  
Comparative Study ◽  
Medicinal Product ◽  
Sore Throat ◽  
Antibiotic Prescription ◽  
Therapeutic Benefit ◽  
Open Label ◽  
Self Assessment ◽  
Acute Tonsillitis ◽  
Link Type ◽  
Delayed Antibiotic Prescription

AbstractAcute bacterial tonsillitis occurs in 20 –30 % of immunocompetent children; however, the frequency of antibacterial drug prescriptions reaches up to 90 %. Delayed antibiotic prescription is recommended by current guidelines. The study objective was to determine the efficacy of phytoneering extract BNO 1030 in the technology of delayed antibiotic prescription in patients with severe acute tonsillitis.MethodsIn the multicenter, randomized, open-label, comparative study, 182 out of 200 randomized children with acute tonsillitis aged 6 –12 years completed the study. Evaluation criteria: a reduced severity of sore throat when swallowing and at rest, throat irritation at rest, hyperemia of the tonsils assessed by a physician according to a 4-point scale at each visit compared to Visit 1, dynamics of self-assessment of general well-being, intensity of sore throat and difficulty swallowing according to a 10-point visual analogue scale, frequency of antibiotic prescriptions, therapeutic benefit from BNO 1030 in days.ResultsThe use of phytotherapeutic medicinal product BNO 1030 in addition to the standard symptomatic treatment of severe acute tonsillitis provides a clinically significant, adequate reduction in the symptom severity assessed by a physician at V2 (p < 0.005). There are significant differences in the patient’s self-assessment of the symptoms from treatment Day 2 (p < 0.005). This allows to significantly reduce the duration of systemic antipyretic administration (p < 0.005). In the first days of treatment, when a decision on delay of antibiotic prescription is made, a therapeutic benefit in two days in patients of the treatment group was observed compared to the control group. The use of BNO 1030 in patients with severe acute tonsillitis significantly reduces, by 43.7 % or 2.3 times, the need for prescribing antibiotic therapy as part of the technology of delayed antibiotic prescription (p < 0.005). During treatment, no side effects and complications of the disease were recorded.ConclusionBNO 1030 is a safe and effective medicinal product for the treatment of severe acute tonsillitis in children aged 6 –12 years. It provides a significant therapeutic benefit when administered in addition to standard symptomatic therapy and reduces the irrational antibiotic prescription.Trial registrationClinicalTrials.gov Identifier: NCT04537819https://clinicaltrials.gov/ct2/show/NCT04537819?term=ATi-2&draw=2&rank=1

scholarly journals A comparative study to assess the efficacy of fluticasone and mometasone in allergic rhinitis

2020 ◽  
Vol 6 (9) ◽  
pp. 1587
Author(s):  
Waqar Ul Hamid ◽  
Deepshikha Sumbria ◽  
Ihsan Ali ◽  
Rauf Ahmad
Keyword(s):  
Allergic Rhinitis ◽  
Comparative Study ◽  
Nasal Spray ◽  
Allergic Diseases ◽  
Therapeutic Benefit ◽  
Nasal Symptom ◽  
Open Label ◽  
Nasal Sprays ◽  
Parallel Group ◽  
The Difference

<p class="abstract"><strong>Background:</strong> Allergic rhinitis is the most prevalent of allergic diseases in the world. Pharmacotherapy remains the mainstay of treatment.  Nasal corticosteroids being the most applicable drugs for its treatment. The objective of this study was to compare the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.</p><p class="abstract"><strong>Methods:</strong> A prospective, randomized, open-label, parallel-group, comparative study was conducted among 80 allergic rhinitis patients fulfilling the inclusion and exclusion criteria. They were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 µg dose of MF nasal spray (1 spray/nostril) daily for 8 weeks. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 weeks after the beginning of the treatment.  </p><p class="abstract"><strong>Results:</strong> At the end of eight weeks of treatment, both groups showed statistically significant (p&lt;0.005) improvements from their baseline TNSS. Mean TNSS was reduced from to 9.46 to 2.716 in FP group and from 10.18 to 2.504 in MF group.</p><p class="abstract"><strong>Conclusions:</strong> Both the groups showed a significant therapeutic benefit in patients with allergic rhinitis. Even though, the difference between the two is not significant for 8 weeks therapy.   </p>

scholarly journals A randomized, open-label, multicentre, comparative study of therapeutic efficacy, preventive potential and tolerability of BNO 1030 extract, containing Althea root, Chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Vasyl Popovych ◽  
Ivana Koshel ◽  
Oleksandr Malofiichuk ◽  
Lubov Pyletska ◽  
Oleksandr Semenyuk ◽  
...  
Keyword(s):  
Comparative Study ◽  
Therapeutic Efficacy ◽  
Control Point ◽  
Evaluation Criteria ◽  
Clinical Manifestations ◽  
Symptomatic Treatment ◽  
Open Label ◽  
Acute Tonsillitis ◽  
To Receive

Abstract Acute tonsillitis tends to recur. In cases where patients do not meet the Paradise criteria, the possibilities of non-surgical treatment are more often considered. The objective of this study was to evaluate the therapeutic efficacy during the long-term follow-up and the effect on the recurrence of the phytoneering extract BNO 1030 (Imupret®) in patients with acute non-bacterial tonsillitis. Methods In this Randomized, Open-Label, Multicentre, Comparative Study, 238 outpatients aged 6–18 years were randomized to receive either BNO 1030 (Imupret®) for 4 weeks in addition to standard symptomatic treatment, or to receive standard treatment. Evaluation criteria: reduction in the symptom severity less than 1 point, the number of tonsillitis recurrences at each control point after 3, 6 and 12 months during the one-year follow-up. Results A significant reduction in the severity of local symptoms and the general condition at each control point within the year of follow-up and a significant decrease (by 66.56%) in the recurrence rate of tonsillitis were noted. The anti-recurrent action was manifested during within the year of follow-up. All patients tolerated phytotherapy well; no adverse reactions were noted. Conclusions BNO 1030 (Imupret®) is a safe and effective medicinal product for acute non-bacterial tonsillitis in children aged 6–18 years. In addition to the main symptomatic treatment, it leads to a significant reduction in the clinical manifestations and the number of recurrences of tonsillitis within the year of follow-up. Trial registration This trial was registered in German Clinical Trials Register retrospectively on June 27, 2018. Trial Acronym: ATi-1 DRKS-ID: DRKS00015020

scholarly journals AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gareth O. Griffiths ◽  
Richard FitzGerald ◽  
Thomas Jaki ◽  
Andrea Corkhill ◽  
Helen Reynolds ◽  
...  
Keyword(s):  
Phase I ◽  
Early Stage ◽  
Late Phase ◽  
Optimum Dose ◽  
Open Label ◽  
Link Type ◽  
Hospitalised Patients ◽  
Volunteer Study ◽  
The Uk ◽  
Phase Trial

Abstract Background There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. Methods/design AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. Discussion Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. Trial registration EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183 19 February 2021 ISRCTN reference: 27106947

scholarly journals A novel MSC-based immune induction strategy for ABO-incompatible liver transplantation: a phase I/II randomized, open-label, controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Yingcai Zhang ◽  
Jiebin Zhang ◽  
Huimin Yi ◽  
Jun Zheng ◽  
Jianye Cai ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Hepatic Failure ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Trial Registration ◽  
Biliary Complications ◽  
Open Label ◽  
Antibody Mediated Rejection ◽  
Link Type ◽  
Induction Strategy

Abstract Background ABO-incompatible liver transplantation (ABO-i LT) has become a rescue therapeutic option for patients with severe hepatic failure. Although the use of rituximab greatly reduces the morbidity of antibody-mediated rejection (AMR), severe adverse effects, such as infection and biliary complications, still seriously threaten the survival of transplant recipients. The aim of this study was to evaluate the safety and feasibility of using mesenchymal stem cells (MSCs) to replace rituximab in ABO-i LT. Methods Twenty-two patients with severe hepatic failure undergoing ABO-i LT were enrolled and randomly divided into two groups: the MSC group and the rituximab group. The safety of the application of MSCs and the incidence of allograft rejection, including antibody-mediated rejection (AMR) and acute cellular rejection (ACR), were evaluated in both groups at the 2-year follow-up period as primary endpoints. Recipients and graft survival and other postoperative complications were compared as secondary endpoints. Results No severe MSC-related adverse events were observed during the trial. MSC treatment yielded comparable, if not better, results than rituximab at decreasing the incidence of acute rejection (9.1% vs 27.3%). Inspiringly, compared to those in the rituximab group, the rates of biliary complications (0% vs 45.5%) and infection (9.1% vs 81.8%) were significantly decreased in the MSC group. In addition, there were no significant differences in 2-year graft and recipient survival between the two groups (81.8% vs 72.7%). Conclusions Our data show that MSC transfusion is comparable to rituximab treatment for AMR prophylaxis following ABO-i LT. Additionally, the results indicate that MSCs are more beneficial to the prevention of infection and biliary complications and may be introduced as a novel immunosuppressive approach for ABO-i LT. Trial registration Trial registration: chictr.org.cn, ChiCTR2000037732. Registered 31 August 2020- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=57074.

scholarly journals Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Paul Sondo ◽  
Marc Christian Tahita ◽  
Toussaint Rouamba ◽  
Karim Derra ◽  
Bérenger Kaboré ◽  
...  
Keyword(s):  
Vitamin A ◽  
Burkina Faso ◽  
Malaria Incidence ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Micronutrient Deficiencies ◽  
Open Label ◽  
Link Type ◽  
Potential Factors ◽  
Combined Strategy

Abstract Background Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing malaria incidence among children aged 3–59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. Malnutrition, in particular micronutrient deficiency, appears to be one of the potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the incidence of malaria in highly prevalent malaria zone such as rural settings. Therefore, we hypothesized that a combined strategy of SMC together with a daily oral nutrients supplement will enhance the immune response and decrease the incidence of malaria and malnutrition among children under SMC coverage. Methods Children (6–59 months) under SMC coverage receiving vitamin A supplementation will be randomly assigned to one of the three study arms (a) SMC + vitamin A alone, (b) SMC + vitamin A + zinc, or (c) SMC + vitamin A + Plumpy’Doz™ using 1:1:1 allocation ratio. After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed-up for 1 year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, haemoglobin measurement, and spotted onto filter paper for further PCR analyses. The primary outcome measure is the incidence of malaria in each arm. Secondary outcome measures will include mid-upper arm circumference and weight gain from baseline measurements, coverage and compliance to SMC, occurrence of adverse events (AEs), and prevalence of molecular markers of antimalarial resistance comprising Pfcrt, Pfmdr1, Pfdhfr, and Pfdhps. Discussion This study will demonstrate an integrated strategy of malaria and malnutrition programmes in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels. Trial registration ClinicalTrials.gov NCT04238845. Registered on 23 January 2020 https://clinicaltrials.gov/ct2/show/NCT04238845

scholarly journals A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Erol Karaaslan ◽  
Sedat Akbas ◽  
Ahmet Selim Ozkan ◽  
Cemil Colak ◽  
Zekine Begec
Keyword(s):  
Laryngeal Mask Airway ◽  
Adverse Events ◽  
Endotracheal Tube ◽  
Sore Throat ◽  
Fiberoptic Bronchoscopy ◽  
Laryngeal Mask ◽  
Controlled Clinical Trial ◽  
Airway Protection ◽  
Link Type ◽  
Single Blind

Abstract Background There are doubts among anesthesiologists on the use of the Laryngeal Mask Airway (LMA) in nasal surgeries because of concerns about the occurrence of blood leakages to the airway. We hypothesized that the use of LMA-Supreme (LMA-S) in nasal surgery is comparable with endotracheal tube (ETT) according to airway protection against blood leakage through the fiberoptic bronchoscopy, oropharyngeal leakage pressure (OLP), heart rate (HR), mean arterial pressure (MAP), and postoperative adverse events. Methods The present study was conducted in a prospective, randomized, single-blind, controlled manner on 80 patients, who underwent septoplasty procedures under general anesthesia, after dividing them randomly into two groups according to the device used (LMA-S or ETT). The presence of blood in the airway (glottis/trachea, distal trachea) was analyzed with the fiberoptic bronchoscope and a four-point scale. Both groups were evaluated for OLP; HR; MAP; postoperative sore throat, nausea, and vomiting; dysphagia; and dysphonia. Results In the fiberoptic evaluation of the airway postoperatively, less blood leakage was detected in both anatomic areas in the LMA-S group than in the ETT group (glottis/trachea, p = 0.004; distal trachea, p = 0.034). Sore throat was detected less frequently in the LMA-S group at a significant level in the 2nd, 6th, and 12th hours of postoperative period; however, other adverse events were similar in both groups. Hemodynamic parameters were not different between the two groups. Conclusion The present findings demonstrate that the LMA-S provided more effective airway protection than the ETT in preventing blood leakage in the septoplasty procedures. We believe that the LMA-S can be used safely and as an alternative to the ETT in septoplasty cases. Trial registration This trial is registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT03903679 on April 5, 2019.

scholarly journals POS1038 THE EFFECT OF FILGOTINIB ON ENTHESITIS: 100-WEEK DATA FROM AN OPEN-LABEL EXTENSION STUDY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 792.2-793
Author(s):  
P. Helliwell ◽  
L. C. Coates ◽  
F. Van den Bosch ◽  
D. D. Gladman ◽  
L. Gheyle ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Treatment Effect ◽  
Janus Kinase ◽  
Research Support ◽  
Rapid Improvement ◽  
Open Label ◽  
Lateral Epicondyle ◽  
Link Type ◽  
Open Label Extension ◽  
Discriminatory Capacity

Background:Filgotinib (FIL), a novel preferential Janus kinase 1 inhibitor, was assessed in patients with active psoriatic arthritis (PsA) in the 16-week, Phase 2, EQUATOR trial (NCT03101670).1 EQUATOR2 (NCT03320876) is the open-label extension (OLE). As previously reported, an interim analysis of the OLE showed that the majority of patients had clinical resolution of enthesitis by Week 52.2Objectives:This post-hoc analysis evaluated the effect of FIL on clinical enthesitis after 100 weeks of treatment in the OLE, as assessed using the Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada (SPARCC) index, and evaluated the discriminatory capacity of the two indices. In addition, we assessed which of the sites included in LEI and SPARCC were most frequently involved and whether treatment effect was consistent across sites.Methods:In EQUATOR, patients with active moderate-to-severe PsA (≥5 swollen joints and ≥5 tender joints, fulfilling Classification for PsA criteria) were randomised 1:1 to receive oral FIL 200 mg or placebo (PBO) once daily (QD) for 16 weeks. At Week 16, all patients could continue into the OLE, receiving FIL 200 mg QD for up to an additional 304 weeks. We compared changes from core baseline in LEI and SPARCC measures, the effect on enthesitis at sites included in LEI and SPARCC assessments and the discriminatory capacity of both enthesitis indices.Results:Of 131 patients randomised to EQUATOR, 122 entered the OLE. There was strong agreement between LEI and SPARCC at baseline. While most patients had enthesitis at baseline according to either index (76/131 [58.0%] by LEI; 85/131 [64.9%] by SPARCC), a minority had enthesitis at a large number of sites (6.9% with 5–6 LEI sites; 12.2% with ≥9 SPARCC sites). The sites most frequently involved at baseline were the lateral epicondyle humerus and Achilles tendon, sites common to both LEI and SPARCC. There was greater variability in the change from baseline to Week 16 in SPARCC compared with LEI (Table 1). LEI showed a greater discriminatory capacity than SPARCC when change from baseline was compared for FIL vs PBO at Week 16, as shown by higher absolute standardised mean difference: −0.70 (LEI) and −0.30 (SPARCC) (observed cases; Table 1). Subgroup analyses indicated that the treatment effect of FIL vs PBO at Week 16 for all sites was consistent with the overall treatment effect seen for LEI or SPARCC, and indicative of an improvement with FIL vs PBO for nearly all sites. The proportion of patients with enthesitis decreased from baseline up to OLE Week 100 (Figure 1). There were no major differences in long-term effect on enthesitis between sites.Conclusion:FIL improved enthesitis consistently across sites compared with PBO. Rapid improvement in enthesitis was seen up to Week 16 of the core study and improvements continued up to Week 52, after which responses were generally stable up to Week 100. LEI assesses fewer locations than SPARCC, but reassuringly captured the sites most commonly affected by enthesitis; LEI also had greater discriminatory capacity.References:[1]Mease P, et al. Lancet 2018;392:2367–77[2]Mease P, et al. Arthritis Rheumatol 2020;72(suppl 10): abstract 0910Figure 1.Acknowledgements:EQUATOR and EQUATOR2 were sponsored by Galapagos NV (Mechelen, Belgium) and co-funded by Galapagos NV and Gilead Sciences, Inc (Foster City, CA, USA). Eline Vetters, Leen Gilles, Benjamin Pett and his team, all employees of Galapagos, provided assistance with statistical analyses. Medical writing/editorial support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Galapagos NV.Disclosure of Interests:Philip Helliwell Speakers bureau: Janssen, Novartis, Paid instructor for: Pfizer, Consultant of: Eli Lilly, Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, Medac, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Novartis, and Pfizer, Filip van den Bosch Consultant of: AbbVie, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Merck and UCB, Dafna D Gladman Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Lien Gheyle Shareholder of: Galapagos, Employee of: Galapagos, Mona Trivedi Shareholder of: Gilead Sciences, Amgen, Employee of: Gilead Sciences, Muhsen Alani Shareholder of: Gilead Sciences, Employee of: Gilead Sciences, Franck Olivier Le Brun Shareholder of: Galapagos, Employee of: Galapagos, Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer, SUN and UCB.

scholarly journals Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Otitis Media ◽  
Conjugate Vaccine ◽  
Otitis Media With Effusion ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Open Label ◽  
Suppurative Otitis Media ◽  
Link Type

Abstract Background Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Methods In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM). Results Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM. Conclusions Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life. Trial registration ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.

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