DESIGN: Cross-sectional study.
SETTING: Lahore, the second largest metropolis in Pakistan.
PARTICIPANTS: This study was conducted among parents residing in Lahore from March to April 2023. Participants were recruited via convenience sampling.
OUTCOME MEASURES: Data were collected using a prevalidated questionnaire that consisted of four sections: (1) informed consent, (2) demographic details, (3) COVID-19 vaccine uptake in children aged 5-17 years, parents' experience with childhood COVID-19 vaccination and their intention to vaccinate their unvaccinated children and (4) a modified 5C scale tailored to determine parents' confidence, complacency, constraints, calculation and collective responsibility with regard to COVID-19 vaccination.
RESULTS: This study included 414 parents (median age=37 years; mothers=62%). COVID-19 vaccination rates for children in the age groups 12-17 years and 5-11 years were 72.5% and 30.1%, respectively. Transient adverse events following immunisation were reported by 32.7% of parents. Of parents with unvaccinated children aged 12-17 years, only 35% intended to vaccinate them. The majority of parents were not willing to vaccinate their children below 11 years of age. Parents with a self-reported positive history of COVID-19 disease (OR=2.531, p=0.016), and confident in the vaccine's safety and efficacy (OR=1.968, p=0.010), were more inclined to vaccinate their 5-11 years. In terms of vaccination of children below 5 years, confidence in the vaccine (OR=2.942, p=0.003) and a sense of collective responsibility were positive predictors (OR=2.260, p=0.035), while calculation was identified as a negative predictor of parents' intention to vaccinate their under 5 years (OR=0.421, p=0.018).
CONCLUSION: CVH was significantly higher among parents of children aged 5-11 years and children younger than 5 years old. Priority should be given by health authorities to address parental concerns about vaccines and ensure that parents understand the significance of vaccination in protecting their children, to increase vaccination rates. This is because hesitancy towards one specific vaccine can negatively impact hesitancy rates in general.
METHODS AND ANALYSIS: This is an open-label, multicentre, single-arm, phase 2 study of pembrolizumab plus PG for first-line treatment in subjects with R/M HNSCC in Malaysia. The study is conducted using the Optional Simon optimal 2-stage design. At the initial stage, 26 subjects will be enrolled and if seven or more patients achieve an objective response rate (ORR), then 63 patients will be enrolled. Subjects will be given pembrolizumab 200 mg3 every 3 weeks up to 35 cycles in combination with chemotherapy for up to six cycles of platinum (either cisplatin at 35 mg/m2 intravenous on day 1 and day 8 or carboplatin at area under the curve 5 intravenous on day 1 of each 3-week cycle) and gemcitabine at 1250 mg/m2 intravenous on days 1 and 8 of a 3-week cycle. The primary end point is the ORR as per Response Evaluation Criteria in Solid Tumors 1.1. Secondary end points include the overall survival, progression free survival, response duration and safety. The exploratory objectives include relationships of microbiome profiles, prognostic and predictive biomarkers with the clinical responses.
ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the University Malaya Medical Centre (202213-10884). Findings will be disseminated through conference presentations and peer review publications.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (www.
CLINICALTRIAL: gov); NCT05286619.