Effectiveness of rotavirus vaccination in prevention of hospital admissions for rotavirus gastroenteritis among young children in Belgium: case-control studyBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e4752 (Published 08 August 2012) Cite this as: BMJ 2012;345:e4752
- Tessa Braeckman, predoctoral researcher1,
- Koen Van Herck, senior lecturer in vaccinology and public health12,
- Nadia Meyer, epidemiology director3,
- Jean-Yves Pirçon, study biostatistician3,
- Montse Soriano-Gabarró, head of global epidemiology4,
- Elisabeth Heylen, predoctoral researcher5,
- Mark Zeller, predoctoral researcher5,
- Myriam Azou, paediatrician6,
- Heidi Capiau, paediatrician7,
- Jan De Koster, paediatrician8,
- Anne-Sophie Maernoudt, paediatrician9,
- Marc Raes, paediatrician10,
- Lutgard Verdonck, paediatrician11,
- Marc Verghote, paediatrician12,
- Anne Vergison, paediatrician13,
- Jelle Matthijnssens, postdoctoral researcher5,
- Marc Van Ranst, professor faculty of medicine5,
- Pierre Van Damme, professor faculty of medicine1
- on behalf of the RotaBel Study Group
- 1Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium
- 2Public Health Department, Ghent University, Ghent, Belgium
- 3GlaxoSmithKline Biologicals, Wavre, Belgium
- 4Bayer Healthcare Pharmaceuticals, Berlin, Germany
- 5Clinical and Epidemiological Virology, KU Leuven, Belgium
- 6AZ Damiaan, Paediatric Department, Ostend, Belgium
- 7AZ St Lucas, Paediatric Department, Ghent
- 8ZOL (Ziekenhuis Oost-Limburg), Campus Sint-Jan, Department of Paediatrics, Genk, Belgium
- 9Clinic St Pierre, Paediatric Department, Ottignies, Belgium
- 10Jessa Hospital, Paediatric Department, Hasselt, Belgium
- 11AZ Alma, Paediatric Department, Eeklo, Belgium
- 12CHR Namur, Paediatric Department, Namur, Belgium
- 13University Hospital for Children, Infectious Diseases Unit, Brussels
- Correspondence to: P Van Damme
- Accepted 13 June 2012
Objective To evaluate the effectiveness of rotavirus vaccination among young children in Belgium.
Design Prospective case-control study.
Setting Random sample of 39 Belgian hospitals, February 2008 to June 2010.
Participants 215 children admitted to hospital with rotavirus gastroenteritis confirmed by polymerase chain reaction and 276 age and hospital matched controls. All children were of an eligible age to have received rotavirus vaccination (that is, born after 1 October 2006 and aged ≥14 weeks).
Main outcome measure Vaccination status of children admitted to hospital with rotavirus gastroenteritis and matched controls.
Results 99 children (48%) admitted with rotavirus gastroenteritis and 244 (91%) controls had received at least one dose of any rotavirus vaccine (P<0.001). The monovalent rotavirus vaccine accounted for 92% (n=594) of all rotavirus vaccine doses. With hospital admission as the outcome, the unadjusted effectiveness of two doses of the monovalent rotavirus vaccine was 90% (95% confidence interval 81% to 95%) overall, 91% (75% to 97%) in children aged 3-11 months, and 90% (76% to 96%) in those aged ≥12 months. The G2P genotype accounted for 52% of cases confirmed by polymerase chain reaction with eligible matched controls. Vaccine effectiveness was 85% (64% to 94%) against G2P and 95% (78% to 99%) against G1P. In 25% of cases confirmed by polymerase chain reaction with eligible matched controls, there was reported co-infection with adenovirus, astrovirus and/or norovirus. Vaccine effectiveness against co-infected cases was 86% (52% to 96%). Effectiveness of at least one dose of any rotavirus vaccine (intention to vaccinate analysis) was 91% (82% to 95%).
Conclusions Rotavirus vaccination is effective for the prevention of admission to hospital for rotavirus gastroenteritis among young children in Belgium, despite the high prevalence of G2P and viral co-infection.
We recognise the invaluable contribution of all staff involved in the conduct of this study at all the participating hospitals.
RotaBel study group
Filip Adriaens, Bert Beulens, André Bochner, Johan Colpaert, Jean De Bock, Marie-Laura Gielen, An Heyneman, Marianne Michel, Inge Matthijs, Louis Oosterlynck, Michel Pletincx, Ilse Ryckaert, Annick Sauvage, Emmi Van Damme, Ilse Vlemincx, Philippe Watillon.
Contributors: NM, PVD, MS-G, and KVH designed the study. Marcela Gavigan, Catherine Cops, Catherine Celis, Virginie Carlier, Benoit Lesage, Tine Wellens, and Sophie Vandenabeele, worked on study set up in all centres. MA, HC, JDK, A-SM, MR, LV, MV, AV and the RotaBel study group were responsible for enrolment of participants and data acquisition. EH, MZ, JM, and MVR performed the laboratory analysis. TB was responsible for data acquisition, data management, training and coordination of study staff. Pascale Schrauben and Cyrille Cartier (statistical programmers) worked on the statistical analysis. NM, MS-G, J-YP, and PVD reviewed the data. TB, KVH, and PVD wrote the first draft of the manuscript. Uta Gomes and TB contributed to the publication coordination and editorial management All authors had access to the data used in this paper, contributed to the writing of the manuscript, and have seen and approved the final version.
Funding: This study was funded by GlaxoSmithKline Biologicals, which helped with study design, data collection, and analysis. GlaxoSmithKline Biologicals also funded Jennifer Coward (independent medical writer, Bollington, UK) to help with writing the paper.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the local ethics committees of all participating hospitals and the ethics committee at Antwerp University Hospital. Written informed consent was obtained from the parents/guardians of all participating children before to any study procedures.
Data sharing: No additional data available.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.