PMID- 35232594
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220418
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 40
IP  - 14
DP  - 2022 Mar 25
TI  - Second dose of measles-mumps-rubella-varicella vaccine (MMRV) and the risk of 
      febrile convulsions.
PG  - 2168-2172
LID - S0264-410X(22)00222-5 [pii]
LID - 10.1016/j.vaccine.2022.02.072 [doi]
AB  - INTRODUCTION: Studies have shown an increased risk of febrile convulsions (FC) 
      after first immunization with the quadrivalent measles-mumps-rubella-varicella 
      vaccine (MMRV) compared to a first dose of measles-mumps-rubella vaccine (MMR) 
      only or in combination with separately administered varicella vaccine (MMR + V). 
      Therefore, it is recommended to give MMR + V at first dose and MMRV or MMR + V at 
      second dose. Little is known on the risk of FC after MMRV at second dose, 
      especially whether the risk depends on age, sex, history of FC or type of first 
      dose vaccine. METHODS: A retrospective cohort study using claims data from the 
      German Pharmacoepidemiological Research database (GePaRD) was performed in 
      children born between January 1st, 2004 and October 31st, 2015 who received two 
      doses of MMRV, MMR + V or MMR. Cases were defined as hospitalization with a 
      diagnosis of FC without neurological conditions coded as main discharge 
      diagnosis. Unadjusted and adjusted odds ratios (OR) with 95% confidence intevals 
      (CIs) were calculated to compare the risk of FC. Stratified analyses were 
      performed to examine potential effect modification by age, sex, history of FC or 
      type of first dose vaccine. RESULTS: In the first 30 days after second dose 
      vaccination, 464 FCs were observed in a cohort of 528,639 children with a median 
      age of 17 months. After adjustment for potential confounders, the adjusted OR for 
      FC in the 30 days after vaccination was 1.25 (95% CI 0.67-2.30) for MMRV compared 
      to MMR + V and 1.04 (0.82-1.32) for MMRV compared to MMR. History of FC was the 
      most important risk factor with an OR of 36.26 (29.30-44.89). We found no effect 
      modification by age, sex, history of FC, or type of first dose vaccine. 
      CONCLUSION: Use of MMRV at second dose is not associated with an increased risk 
      of FC compared to MMR + V or MMR, irrespective of age, sex, history of FC, or 
      type of first dose vaccine.
CI  - Copyright (c) 2022 Elsevier Ltd. All rights reserved.
FAU - Schafer, Wiebke
AU  - Schafer W
AD  - Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstr. 30, 
      28359 Bremen, Germany.
FAU - Reinders, Tammo
AU  - Reinders T
AD  - Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstr. 30, 
      28359 Bremen, Germany.
FAU - Schink, Tania
AU  - Schink T
AD  - Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstr. 30, 
      28359 Bremen, Germany. Electronic address: schink@leibniz-bips.de.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220226
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Antibodies, Viral
MH  - Chickenpox Vaccine
MH  - Child
MH  - Humans
MH  - Infant
MH  - *Measles/prevention & control
MH  - Measles-Mumps-Rubella Vaccine
MH  - *Mumps/prevention & control
MH  - Retrospective Studies
MH  - *Rubella/prevention & control
MH  - *Seizures, Febrile/chemically induced/epidemiology
MH  - Vaccines, Combined
OTO - NOTNLM
OT  - Children
OT  - Immunization
OT  - Measles-mumps-rubella
OT  - Observational study
OT  - Safety
OT  - Vaccination
OT  - Varicella
COIS- Declaration of Competing Interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: A precursor study based on data from 2004 to 2008 was financed by 
      GLAXOSMITHKLINE BIOLOGICALS SA. This study as well as the precursor study were 
      performed in line with the ENCePP Code of Conduct. The authors had complete 
      autonomy in the process of establishing the protocol, carrying out the analyses, 
      and interpreting the results. The authors retained the full right to publish the 
      results without limitation. TS is working at an independent, non-profit research 
      institute, the Leibniz Institute for Prevention Research and Epidemiology - BIPS. 
      Unrelated to this study, BIPS occasionally conducts studies financed by the 
      pharmaceutical industry. Almost exclusively, these are post-authorization safety 
      studies (PASS) requested by health authorities and are performed in line with the 
      ENCePP Code of Conduct.
EDAT- 2022/03/03 06:00
MHDA- 2022/04/19 06:00
CRDT- 2022/03/02 05:46
PHST- 2021/10/20 00:00 [received]
PHST- 2022/01/18 00:00 [revised]
PHST- 2022/02/18 00:00 [accepted]
PHST- 2022/03/03 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2022/03/02 05:46 [entrez]
AID - S0264-410X(22)00222-5 [pii]
AID - 10.1016/j.vaccine.2022.02.072 [doi]
PST - ppublish
SO  - Vaccine. 2022 Mar 25;40(14):2168-2172. doi: 10.1016/j.vaccine.2022.02.072. Epub 
      2022 Feb 26.