Two large-scale, phase III/IV, randomized clinical trials have demonstrated vaccine effectiveness or efficacy (VE) in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes or any serotype when SYNFLORIX was given to infants in either 2+1 or 3+1 schedules in the FinIP clinical trial, or 3+1 schedule in the COMPAS trial. 1
671 = the number needed to vaccinate (NNV) to prevent one case of IPD during 2 years of follow-up*3
In the COMPAS clinical trial, the observed vaccine efficacy against IPD due to vaccine serotypes reported in the According To Protocol Cohort (ATP) cohort was 100%. The observed VE against IPD due to any serotype reported in the ATP cohort was 65.0%.†1
The effectiveness of SYNFLORIX has been observed against vaccine serotype and cross-reactive serotype 19A IPD.
In Quebec, an established post-marketing study has shown that SYNFLORIX vaccine effectiveness
(≥ 1 dose) was 97% against vaccine-type and 6A IPD and 71% against 19A IPD.
As with all post-marketing observational studies, these results should be interpreted with caution.
* Double-blind, cluster-randomized, controlled study in Finland in which children were randomized into 4 groups according to the 2 infant vaccination schedules [2-dose, N=10,054 (3, 5 months of age) or 3-dose, N=10,273 (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either SYNFLORIX (2/3 of clusters) or hepatitis vaccines as control (1/3 of clusters, N=10,200). In the catch-up cohorts, children between 7-11 months of age at first dose received 2 doses of either SYNFLORIX or hepatitis B control vaccine followed by a booster, and children between 12-18 months of age at first dose received 2 doses of either SYNFLORIX or hepatitis A control vaccine. Average follow-up, from first vaccination, was 24 to 28 months for invasive disease, hospital-diagnosed pneumonia and outpatient antimicrobial prescriptions. 1
† Double-blind study in healthy infants aged 6 to 16 weeks who were randomized to SYNFLORIX or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either SYNFLORIX or hepatitis A control vaccine at 15 to 18 months of age. The ATP cohort was defined as the group of participants who received their assigned intervention. 1 4
‡ Results from an established post-marketing study in Quebec that has been in place since 2005 to estimate vaccine effectiveness against IPD in children aged 2 to 59 months of age. To date, results of this study have included an 8-year study period when PCV7 (PREVNAR), PCV10 (SYNFLORIX) and PCV13 (PREVNAR 13) were used sequentially in that province. 1