Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine.
BACKGROUND
In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies was not sufficient to examine the risk of uncommon but serious adverse events.


OBJECTIVE
To assess the risk of serious adverse events following DTaP-IPV vaccination.


METHODS
The study was conducted from January 2009 through September 2012 in the Vaccine Safety Datalink (VSD) project. In the VSD, electronic vaccination and encounter data are updated and aggregated weekly as part of ongoing surveillance activities. Based on previous reports and biologic plausibility, eight potential adverse events were monitored: meningitis/encephalitis; seizures; stroke; Guillain-Barré syndrome; Stevens-Johnson syndrome; anaphylaxis; serious allergic reactions other than anaphylaxis; and serious local reactions. Adverse event rates in DTaP-IPV recipients were compared to historical incidence rates in the VSD population prior to 2009. Sequential probability ratio testing was used to analyze the data on a weekly basis.


RESULTS
During the study period, 201,116 children received DTaP-IPV vaccine. Ninety-seven percent of DTaP-IPV recipients also received other vaccines on the same day, typically measles-mumps-rubella and varicella vaccines. There was no statistically significant increased risk of any of the eight pre-specified adverse events among DTaP-IPV recipients when compared to historical incidence rates.


CONCLUSIONS
In this safety surveillance study of more than 200,000 DTaP-IPV vaccine recipients, there was no evidence of increased risk for any of the pre-specified adverse events monitored. Continued surveillance of DTaP-IPV vaccine safety may be warranted to monitor for rare adverse events, such as Guillain-Barré syndrome.
Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80231, United States; Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States. Electronic address: matthew.f.daley@kp.org.
Matthew F
MF
Daley
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215, United States. Electronic address: katherine_yih@harvardpilgrim.org.
W Katherine
WK
Yih
Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80231, United States. Electronic address: jason.m.glanz@kp.org.
Jason M
JM
Glanz
Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80231, United States; Department of Pediatrics, University of Colorado School of Medicine, 13123 East 16th Avenue, Box 065, Aurora, CO 80045, United States; Community Health Services, Denver Health, 777 Bannock Street, Denver, CO 80204, United States. Electronic address: simon.hambidge@dhha.org.
Simon J
SJ
Hambidge
Institute for Health Research, Kaiser Permanente Colorado, 10065 E. Harvard Avenue, Denver, CO 80231, United States. Electronic address: komal.j.narwaney@kp.org.
Komal J
KJ
Narwaney
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215, United States. Electronic address: ryin1000@yahoo.com.
Ruihua
R
Yin
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215, United States. Electronic address: lingling_li@harvardpilgrim.org.
Lingling
L
Li
Biostatistics Unit, Group Health Research Institute, 1730 Minor Ave #1600, Seattle, WA 98101, United States; Department of Biostatistics, University of Washington, 5th Floor, 1107 NE 45th St., Seattle, 98105, United States. Electronic address: nelson.jl@ghc.org.
Jennifer C
JC
Nelson
HealthPartners Institute for Education and Research, Mail stop 21111R, PO Box 1524, Minneapolis, MN 55440-1524, United States. Electronic address: james.d.nordin@healthpartner.scom.
James D
JD
Nordin
Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612, United States. Electronic address: nicola.klein@kp.org.
Nicola P
NP
Klein
Department of Research and Evaluation, Kaiser Permanente Southern California, 100 South Los Robles Avenue, 2nd Floor, Pasadena, CA 91101, United States. Electronic address: steven.j.jacobsen@kp.org.
Steven J
SJ
Jacobsen
Immunization Safety Office, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333, United States. Electronic address: eiw8@cdc.gov.
Eric
E
Weintraub
D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects*; D057286:Electronic Health Records; D006801:Humans; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D014481:United States; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects
C051021:DTPP vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined
Acellular pertussis; Diphtheria; Immunization; Inactivated poliovirus combined vaccine; Surveillance; Tetanus; Vaccine; Vaccine safety