Abstract
Background: The Accelerated development of vaccine benefit‐risk
collaboration in Europe (ADVANCE), a private‐public consortium,
implemented and tested a distributed network system for the generation
of best evidence on the benefits‐risks of marketed vaccines in
Europe.
Objectives: We tested the system by estimating the incidence rate (IR)
of pertussis and complications following pertussis in children vaccinated
with acellular (aP) and whole cell (wP) pertussis vaccine.
Methods: Data from 7 electronic databases from 4 countries
(Denmark: AUH and SSI, Spain: SIDIAP and BIFAP, UK: THIN and
RCGP and Italy: Pedianet) was included in a retrospective cohort analysis.
The exposure was defined as any pertussis vaccination (aP or
wP). The exposure time started 14 days after the first dose. All children
receiving any pertussis vaccine were eligible except those
switching from one type to the other, or with unknown type. The
study period was January 1990 to December 2015. The outcomes
of interest were confirmed or suspected pertussis and complications
such as pneumonia and generalized convulsions within 30 days and
death within 90 days of disease onset.
Results: The cohort comprised of 2 938 973 children ≤5 years of age
for the period of 1990‐2015. Data on aP vaccination was available in
all databases while only 4 databases could provide data on wP vaccination.
The IR (per 100 000 person‐years) for pertussis ranged
between 0.15 (95% CI: 0.12; 0.19) and 1.15 (95% CI: 1.07; 1.23),
and the trend over time was consistent with those observed from
national surveillance databases for confirmed pertussis. IR of pertussis
decreased with the number of doses of vaccines received: eg: the incidence
rate after one dose of aP ranged from 0.40 to 2.83 vs post‐dose
3 from 0.03 to 0.68. Complications of break‐through cases were rare
(93 pneumonia, 8 generalized convulsions, and no death) and their relative
risk (vs non‐pertussis) could not be reliably estimated.
Conclusions: The study demonstrated the feasibility of ADVANCE
data distributed system to estimate the IRs of pertussis and its
complications. The trends over time were coherent with those from
national surveillance databases showing external validity. Larger sample
sizes and inclusion of more data sources would provide additional
power.
collaboration in Europe (ADVANCE), a private‐public consortium,
implemented and tested a distributed network system for the generation
of best evidence on the benefits‐risks of marketed vaccines in
Europe.
Objectives: We tested the system by estimating the incidence rate (IR)
of pertussis and complications following pertussis in children vaccinated
with acellular (aP) and whole cell (wP) pertussis vaccine.
Methods: Data from 7 electronic databases from 4 countries
(Denmark: AUH and SSI, Spain: SIDIAP and BIFAP, UK: THIN and
RCGP and Italy: Pedianet) was included in a retrospective cohort analysis.
The exposure was defined as any pertussis vaccination (aP or
wP). The exposure time started 14 days after the first dose. All children
receiving any pertussis vaccine were eligible except those
switching from one type to the other, or with unknown type. The
study period was January 1990 to December 2015. The outcomes
of interest were confirmed or suspected pertussis and complications
such as pneumonia and generalized convulsions within 30 days and
death within 90 days of disease onset.
Results: The cohort comprised of 2 938 973 children ≤5 years of age
for the period of 1990‐2015. Data on aP vaccination was available in
all databases while only 4 databases could provide data on wP vaccination.
The IR (per 100 000 person‐years) for pertussis ranged
between 0.15 (95% CI: 0.12; 0.19) and 1.15 (95% CI: 1.07; 1.23),
and the trend over time was consistent with those observed from
national surveillance databases for confirmed pertussis. IR of pertussis
decreased with the number of doses of vaccines received: eg: the incidence
rate after one dose of aP ranged from 0.40 to 2.83 vs post‐dose
3 from 0.03 to 0.68. Complications of break‐through cases were rare
(93 pneumonia, 8 generalized convulsions, and no death) and their relative
risk (vs non‐pertussis) could not be reliably estimated.
Conclusions: The study demonstrated the feasibility of ADVANCE
data distributed system to estimate the IRs of pertussis and its
complications. The trends over time were coherent with those from
national surveillance databases showing external validity. Larger sample
sizes and inclusion of more data sources would provide additional
power.
| Original language | English |
|---|---|
| Pages (from-to) | 393 |
| Number of pages | 1 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 27 |
| Issue number | S2 |
| Publication status | Published - Aug 2018 |