scholarly journals Pneumococcal Conjugate Vaccine (Non-Typeable Haemophilus influenzae (NTHi) Protein D, Diphtheria or Tetanus Toxoid Conjugates) in Prevention of Acute Otitis Media in Children: A Cohort Study

2016 ◽  
Vol 31 (2) ◽  
pp. 13-15 ◽  
Author(s):  
Trixy G. Chu ◽  
Daniel Rafael R. Cachola ◽  
Mary Agnes S. Regal ◽  
Agnes Cecille G. Llamas ◽  
Norberto V. Martinez ◽  
...  

Objective: To compare the incidence of acute otitis media among children aged 2 to 6 months old in Sampaloc, Manila who were previously given 3 doses of pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) and those who did not receive the vaccine, over a period of one year. Methods: Study Design:             Cohort Study Setting:                       Primary Health Center in Sampaloc, Manila, Philippines Participants:              Medical records of well children aged 2 to 6 months were reviewed for inclusion. Participants were categorized into vaccinated and unvaccinated groups. Both groups underwent baseline history and physical examination including otoscopy and any signs and symptoms of active ear infection were noted.  Subjects were followed up for a period of 1 year on a monthly basis for signs or symptoms of acute otitis media. Results: A total of 176 subjects participated in the study. The overall incidence of AOM among participants was 5.11% (9 out of 176). An AOM incidence of 3.75% (3 out of 80) and 6.25% (6 out of 96) was found among the exposed and unexposed groups, respectively. Fisher’s exact test (one-tailed) p value =.34, relative risk (RR) .6 (95 percent CI 0.155, 2.323). Conclusion: The results of this study showed no difference in the development of AOM in the two groups. However, based on the relative risk, Pneumococcal conjugate vaccine is still beneficial in preventing AOM in children. Keywords: Pneumococcal Conjugate Vaccine; Acute Otitis Media

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  

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.


2018 ◽  
Vol 121 (7) ◽  
pp. 887-898
Author(s):  
Eriko Mokuno ◽  
Miyuki Morozumi ◽  
Kimiko Ubukata ◽  
Tsuyoshi Tajima ◽  
Satoshi Iwata

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