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Invasive pneumococcal disease (IPD)

Demonstrated over 90% vaccine effectiveness and efficacy (VE) in preventing vaccine serotype IPD in two large-scale clinical trials 1

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

In the FinIP clinical trial, the observed vaccine effectiveness against culture-confirmed IPD due to vaccine pneumococcal serotypes or any serotype was:*1 2

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

Effectiveness demonstrated in post-marketing “real-world” observational studies‡ 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

References:

  1. Synflorix Product Monograph. GlaxoSmithKline Inc. August 31, 2018.
  2. Palmu AA et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet 2013;381:214-22.
  3. Palmu AA et al. Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial. Vaccine 2018;36:1816-22.
  4. Tregnaghi MW et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: a double-blind randomized controlled trial. PLoS Med 2014;11:e1001657.

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