Effectiveness of 13-valent pneumococcal conjugate vaccine on radiological primary end-point pneumonia among cases of severe community acquired pneumonia in children: A prospective multi-site hospital-based test-negative study in Northern India.

INTRODUCTION: Community acquired pneumonia (CAP) is a leading cause of under-five mortality in India and Streptococcus pneumoniae is the main bacterial pathogen for it. Pneumococcal Conjugate Vaccine 13 (PCV13) has been introduced in a phased manner, in the national immunization program of India since 2017/2018. The primary objective of this study was to evaluate the effectiveness of PCV13 on chest radiograph (CXR)-confirmed pneumonia, in children hospitalized with WHO-defined severe CAP. METHODS: This prospective, multi-site test-negative study was conducted in a hospital-network situated in three districts of Northern India where PCV13 had been introduced. Children aged 2-23 months, hospitalized with severe CAP and with interpretable CXR were included after parental consent. Clinical data was extracted from hospital records. CXRs were interpreted by a panel of three independent blinded trained radiologists. Exposure to PCV13 was defined as ≥2 doses of PCV13 in children aged ≤ 12 months and ≥ 1 dose(s) in children > 12 months of age. Our outcome measures were CXR finding of primary endpoint pneumonia with or without other infiltrates (PEP±OI); vaccine effectiveness (VE) and hospital mortality. RESULTS: From 1st June 2017-30th April 2021, among 2711 children included, 678 (25.0%) were exposed to PCV1. CXR positive for PEP±OI on CXR was found in 579 (21.4%), of which 103 (17.8%) were exposed to PCV. Adjusted odds ratio (AOR) for PEP±OI among the exposed group was 0.69 (95% CI, 0.54-0.89, p = 0.004). Adjusted VE was 31.0% (95% CI: 11.0-44.0) for PEP±OI. AOR for hospital mortality with PEP±OI was 2.65 (95% CI: 1.27-5.53, p = 0.01). CONCLUSION: In severe CAP, children exposed to PCV13 had significantly reduced odds of having PEP±OI. Since PEP±OI had increased odds of hospital mortality due to CAP, countrywide coverage with PCV13 is an essential priority.

Effectiveness of 3-day amoxycillin vs. 5-day co-trimoxazole in the treatment of non-severe pneumonia in children aged 2-59 months of age: a multi-centric open labeled trial.

This cluster randomized, open labeled trial was conducted to compare the effectiveness of 3 days of oral amoxycillin and 5 days of co-trimoxazole treatment in terms of clinical failure in children with World Health Organization (WHO) defined non-severe pneumonia in primary health centers in rural India. Participants were children aged 2-59 months with WHO defined non-severe pneumonia, with or without wheeze, who were accessible to follow up. From seven primary health centers in each arm, 2009 cases were randomized, 993 and 1016 in treatment with amoxycillin and co-trimoxazole, respectively. Fever was present in 1247 (62.1%) and wheeze in 443 (22.1%). There was good adherence and low loss to follow-up. Clinical failure on amoxycillin and co-trimoxazole on intention to treat analysis was 137 and 97, respectively (absolute difference = 0.04, 95% confidence interval: - 0.035-0.12). We conclude that there was no difference in effectiveness of oral co-trimoxazole or amoxycillin in treating non-severe pneumonia.