Pneumococcal conjugate vaccine compared with control intervention for preventing acute otitis media

Patient or population: children aged 12 years or younger and a follow‐up after vaccinations of at least 6 months

Settings: open population

Intervention: multivalent PCVs

Comparison: control treatment

Frequency of all‐cause AOM

PCV7 administered in early infancy

Follow‐up 6 to 42 months

⊕⊕⊕⊕
high

Results are derived from 1 very large trial (Black 2000/Fireman 2003) and 3 trials of approximately equal size (944 to 1666 participants) (Eskola 2001; Kilpi 2003; O'Brien 2008)

Lowest efficacy was found in high‐risk children (O'Brien 2008)

Frequency of all‐cause AOM

PD‐PCV11 administered in early infancy

Follow‐up 27 months

⊕⊕⊕⊝
moderate

Results derived from 1 high‐quality trial (Prymula 2006)

Part of the effect may be related to the protein D to which the polysaccharides are conjugated in the vaccine PD‐PCV11, demonstrated to reduce non‐typeable H. influenzae by 35% (95% CI 2 to 57)

AOM incidence rate in control group was low compared to the other studies on the effect on PCV7 in infants and the absolute risk difference was small (Table 1)

Frequency of all‐cause AOM

CRM197‐PCV9 administered in healthy toddlers

Follow‐up 24 months

⊕⊕⊕⊝
moderate

Results derived from 1 trial of moderate methodological quality (Dagan 2001). Uncertainty about the effect size (statistically non‐significant effect) and outcome measure (parent‐reported OM)

Frequency of all‐cause AOM

PCV7 administered in older children with a known history of AOM

Follow‐up 6 to 26 months

⊕⊕⊕⊕
high

Results are derived from 2 high‐quality trials (Veenhoven 2003; Van Kempen 2006) and 1 trial of moderate methodological quality (Jansen 2008). The 2 high‐quality trials found no beneficial effect of PCV in preventing AOM recurrences, while the other trial found PCV7/TIV not to be superior to TIV/placebo in preventing AOM during the influenza season

Frequency of pneumococcal AOM

PCV7 administered in early infancy

Follow‐up 6 to 42 months

⊕⊕⊕⊕
high

Results are derived from 2 high‐quality trials (Eskola 2001/Palmu 2009; Kilpi 2003)

Frequency of pneumococcal AOM

PD‐PCV11 administered in early infancy

Follow‐up 27 months

⊕⊕⊕⊝
moderate

Results derived from 1 high‐quality trial in which myringotomy was performed in all children (Prymula 2006)

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

*Results include both ITT and PP results; 95% CI lacking in case of multiple studies (range of effect estimates presented as we refrained from pooling).