Despite an enhanced mixed pneumococcal conjugate vaccine (PCV) schedule, there was still a high prevalence of otitis media among children in early childhood, according to results of a study published in the International Journal of Pediatric Otorhinolaryngology.
The investigators of the study aimed to prevent early childhood otitis media, which is associated with hearing loss and developmental delay, using a mixed PCV schedule. They hoped to maximize immunogenicity and prevent the bacteria, thus preventing educational and social disadvantages in early childhood. The study authors stated that “children with hearing loss are disproportionately at risk of poor school readiness and performance compared to their peers with no hearing loss.”
According to the study authors, Streptococcus pneumoniae (pneumococcus) and non-typeable Haemophilus influenzae (NTHi) have been proven to be dominant pathogens of otitis media after birth. The study was conducted in 2 parallel, open-label, randomized trial.
In the first trial, investigators randomly administered either the 10-valent pneumococcal NTHi conjugate vaccine, PHiD-CV10 (Synflorix; GSK) or the 13-valent PCV, PCV13 (Prevenar13; Pfizer) at ages 2, 4, and 6 months, or to a combination of PHiD-CV10 at age 1, 2, and 4 months, plus PCV13 at age 6 months. In the second trial, investigators randomly administered either PCV13 or PHiD-CV10 at age 12 months, according to the study authors. Investigators recorded the co-primary and secondary outcomes at age 18 months.
Key Takeaways
- High Prevalence of Otitis Media Persists Despite Enhanced Vaccine Schedule: Despite the implementation of an enhanced, mixed pneumococcal conjugate vaccine (PCV) schedule, the study found a high prevalence of otitis media among children in early childhood.
- 2 Parallel, Open-Label, Randomized Trials: The investigators conducted 2 parallel, open-label, randomized trials involving different PCV schedules. In the first trial, researchers administered either the 10-valent pneumococcal NTHi conjugate vaccine (PHiD-CV10) or the 13-valent PCV (PCV13) at various ages. The second trial involved administering either PCV13 or PHiD-CV10 at age 12 months. However, the outcomes showed no statistically significant differences between the vaccine arms at various time points.
- Ineffectiveness of Current Pneumococcal Vaccines in Preventing Otitis Media: The study authors concluded that the currently available pneumococcal vaccines, including PCV13 and PHiD-CV10, did not effectively prevent otitis media in children. Regardless of the primary vaccination schedule or the booster vaccine, there were no significant differences in outcomes.
Investigators included individuals if they were aged 12 months, had previously enrolled in the PREVIX_COMBO 3-arm RCT, and were in 1 of 3 remote communities in the Northern Territory of Australia or a single Western Australian community, according to the study authors. Recruitment began in March 2013, with additional visits at 24 and 30 months in the Northern Territory communities in January 2017, and collection was completed in September 2018.
There were 261 children that received a dose of either vaccine at age 12 months, with 131 receiving the PCV13 vaccine and 130 receiving the PHiD-CV10 vaccine. At baseline, investigators reported that 88% in the PVC13 arm and 92% in the PHiD-CV10 arm developed some form of otitis media, with acute otitis media without perforation being the most common at 47% and 50%, respectively, according to the results.
They found that, at any age, there were no statistically significant differences between both arms. At age 18 months, 88% of children in the PCV13 group and 91% in the PHiD-CV10 group had some form of otitis media while 74% and 88% had some form at age 24 months, respectively.
Furthermore, the study authors reported that at age 36, the increase from baseline was 28% and 27% in the PCV13 group and the PHiD-CV10, respectively, with 71% and 73%, respectively, having otitis media. They concluded that at any time point, there were no differences in outcomes, either by the primary schedule or the booster vaccine. They added that there was a 100% follow-up rate at 18 months, but there were only 30% and 20% in the PCV13 and PHiD-CV10 groups, respectively, at 36 months.
The study authors determined that the current available pneumococcal vaccines do not help prevent otitis media in children.
Reference
Leach AJ, Wilson N, Arrowsmith B, Beissbarth J, et al. Otitis media at 6-monthly assessments of Australian First Nations children between ages 12-36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines. Int J Pediatr Otorhinolaryngol. 2023;175:111776. doi:10.1016/j.ijporl.2023.111776
