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Published on: September 7, 2017
Protective effect of single-dose adjuvanted pandemic influenza vaccine in children
P G Van Buynder1, J K Dhaliwal, J L Van Buynder
1New Brunswick Department of Health, Office of the Chief Medical Officer of Health (OCMOH), Fredericton, NB, Canada. pjvb@iinet.net.au
Insights
A single dose of GSK's adjuvanted vaccine (Arepanrix) provided 100% vaccine effectiveness (VE) against pandemic H1N1 influenza in children under 10 years. This single-dose regimen offers protection and may reduce reactogenicity.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Immunology
Background:
- Pandemic A/California/7/2009(H1N1) influenza caused high pediatric hospitalization rates.
- Vaccination policies for children varied globally, including dose and vaccine type.
- Canadian policy involved a single 0.25 ml dose of GSK's adjuvanted vaccine (Arepanrix) for children 36 months to <10 years.
Purpose of the Study:
- To evaluate the vaccine effectiveness (VE) of a single dose of the GSK adjuvanted vaccine.
- To assess VE in children under 10 years following the 2009 H1N1 pandemic.
- To determine the protective impact of a 0.25 ml dose of Arepanrix.
Main Methods:
- Community-based case-control study design.
- Inclusion of children under 10 years with influenza-like illness tested for H1N1.
- Laboratory-confirmed influenza as the primary outcome.
- Vaccination status as the primary exposure variable.
Main Results:
- No vaccinated children had laboratory-confirmed influenza compared to 38% of controls (14-day efficacy period).
- Vaccine effectiveness (VE) was 100% for children <10 and <5 years.
- VE remained statistically significant (>90%) across all age subgroups, including under 36 months, with a 10-day efficacy period.
Conclusions:
- A single 0.25 ml dose of Arepanrix provides significant protection against pandemic influenza in children.
- This single-dose strategy may mitigate potential reactogenicity from multiple doses.
- Adjuvanted vaccines show promise for enhancing future seasonal influenza vaccines.
Background:
During the first wave of A/California/7/2009(H1N1) influenza, high rates of hospitalization in children under 5 years were seen in many countries. Subsequent policies for vaccinating children varied in both type of vaccine and number of doses. In Canada, children 36 months to <10 years received a single dose of 0.25 ml of the GSK adjuvanted vaccine (Arepanrix) equivalent to 1.9 microg HA. Children 6 months to 35 months received two doses as did those 36-119 months with chronic medical conditions.
Method:
We conducted a community-based case-control vaccine effectiveness (VE) review of children under 10 years with influenza like illness who were tested for H1N1 infection at the central provincial laboratory. Laboratory-confirmed influenza was the primary outcome, and vaccination status the primary exposure to assess VE after a single 0.25-ml dose.
Results:
If vaccination was designated to be effective after 14 days, no vaccinated child had laboratory-confirmed influenza compared to 38% of controls. The VE of 100% was statistically significant for children <10 years of age and <5 years considered separately. If vaccination was considered effective after 10 days, VE dropped to 96% overall but was statistically significant and over 90% in all age subgroups, including those under 36 months.
Conclusions:
A single 0.25-ml dose of the GSK adjuvanted vaccine (Arepanrix) protects children against laboratory-confirmed pandemic influenza potentially avoiding any increased reactogenicity associated with second doses. Adjuvanted vaccines offer hope for improved seasonal vaccines in the future.
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