Risk of Injection-Site Abscess among Infants Receiving a Preservative-Free, Two-Dose Vial Formulation of Pneumococcal Conjugate Vaccine in Kenya.
There is a theoretical risk of adverse events following immunization with a preservative-free, 2-dose vial formulation of 10-valent-pneumococcal conjugate vaccine (PCV10). We set out to measure this risk. Four population-based surveillance sites in Kenya (total annual birth cohort of 11,500 infants) were used to conduct a 2-year post-introduction vaccine safety study of PCV10. Injection-site abscesses occurring within 7 days following vaccine administration were clinically diagnosed in all study sites (passive facility-based surveillance) and, also, detected by caregiver-reported symptoms of swelling plus discharge in two sites (active household-based surveillance). Abscess risk was expressed as the number of abscesses per 100,000 injections and was compared for the second vs first vial dose of PCV10 and for PCV10 vs pentavalent vaccine (comparator). A total of 58,288 PCV10 injections were recorded, including 24,054 and 19,702 identified as first and second vial doses, respectively (14,532 unknown vial dose). The risk ratio for abscess following injection with the second (41 per 100,000) vs first (33 per 100,000) vial dose of PCV10 was 1.22 (95% confidence interval [CI] 0.37-4.06). The comparator vaccine was changed from a 2-dose to 10-dose presentation midway through the study. The matched odds ratios for abscess following PCV10 were 1.00 (95% CI 0.12-8.56) and 0.27 (95% CI 0.14-0.54) when compared to the 2-dose and 10-dose pentavalent vaccine presentations, respectively. In Kenya immunization with PCV10 was not associated with an increased risk of injection site abscess, providing confidence that the vaccine may be safely used in Africa. The relatively higher risk of abscess following the 10-dose presentation of pentavalent vaccine merits further study.
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Deron C
DC
Burton
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Godfrey M
GM
Bigogo
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Allan O
AO
Audi
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; Center for Global Health, CDC, Atlanta, Georgia, United States of America.
John
J
Williamson
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Kenneth
K
Munge
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Jackline
J
Wafula
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Dominic
D
Ouma
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya.
Sammy
S
Khagayi
Division of Vaccines and Immunization, Ministry of Public Health and Sanitation, Nairobi, Kenya.
Isaac
I
Mugoya
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
James
J
Mburu
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Shadrack
S
Muema
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Evasius
E
Bauni
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya.
Tahreni
T
Bwanaali
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Daniel R
DR
Feikin
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Peter M
PM
Ochieng
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Ondari D
OD
Mogeni
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
George A
GA
Otieno
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Beatrice
B
Olack
Division of Vaccines and Immunization, Ministry of Public Health and Sanitation, Nairobi, Kenya.
Tatu
T
Kamau
GlaxoSmithKline Vaccines, Wavre, Belgium.
Melissa K
MK
Van Dyke
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC, Atlanta, Georgia, United States of America.
Robert
R
Chen
Open University, Buckinghamshire, United Kingdom.
Paddy
P
Farrington
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya.
Joel M
JM
Montgomery
International Emerging Infections Program, Global Disease Detection Response Center, CDC, Kisumu and Nairobi, Kenya; Center for Global Health, CDC, Atlanta, Georgia, United States of America.
Robert F
RF
Breiman
KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; London School of Hygiene & Tropical Medicine, London, United Kingdom.
J Anthony G
JA
Scott
Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Research and Public Health Collaboration, Kisumu and Nairobi, Kenya; Center for Global Health, CDC, Atlanta, Georgia, United States of America.
Kayla F
KF
Laserson
D000038:Abscess / Q000453:epidemiology* / Q000209:etiology*; D006801:Humans; D007630:Kenya / Q000453:epidemiology; D011008:Pneumococcal Infections / Q000150:complications* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011159:Population Surveillance; D012306:Risk; D013997:Time Factors; D014611:Vaccination / Q000009:adverse effects; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate