Last updated: 02/26/2020 06:00:15
Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination
Trial description: Invasive meningococcal disease (IMD) is an important cause of meningitis and septicemia. According to the European Centre for Disease Prevention and Control (ECDC) surveillance report for 2007, 74% of IMD was caused by meningococcal capsular group B (MenB), with more than 3,406 cases and a case fatality ratio of almost 7.5%. The incidence of MenB disease is highest in infants and toddlers, followed by another peak in adolescents 15 to 19 years of age. Therefore, the purpose of this study is to investigate the effectiveness of 4CMenB vaccination during routine clinical care in the UK national immunisation programme (NIP).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Confirmed case of capsular group B by culture and/or PCR.
Timeframe: Throughout the study period of 3 years.
Secondary outcomes:
Confirmed or probable case of capsular group B 4CMenB-vaccine-type.
Timeframe: Throughout the study period of 3 years.
Interventions:
Enrollment:
1
Primary completion date:
2018-31-08
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Ladhani SN et al. (2020) Vaccination of Infants With Meningococcal Group B Vaccine (4CMenB) in England.
N Engl J Med. 382 (4): 309-317.
Medical condition
Infections, Meningococcal
Product
GSK3536829A
Collaborators
Not applicable
Study date(s)
September 2015 to August 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
2Months - 12Months
Accepts healthy volunteers
Yes
- Subjects will be enrolled based on the case definitions and study design applicable.
- Subjects who have not received the vaccine.
- Subjects who were not vaccinated according to the NIP.
Inclusion and exclusion criteria
Inclusion criteria:
Subjects will be enrolled based on the case definitions and study design applicable.
Exclusion criteria:
- Subjects who were not vaccinated according to the NIP.
Subjects who have not received the vaccine.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-31-08
Actual study completion date
2018-31-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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