Last updated: 06/17/2021 07:10:04

An observational, retrospective, matched case-control study to assess the effectiveness of Priorix vaccine in children born after 2004 in the United Kingdom (UK).

GSK study ID
212142
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An epidemiological, observational, retrospective, matched case-control study to assess the effectiveness of Priorix vaccine against measles and mumps diseases in children born after 2004 in the United Kingdom (UK)
Trial description: This study aims to assess the effectiveness of measles, mumps and rubella (MMR) vaccine against 2 highly contagious diseases, measles and mumps, in children born after 2004 in the UK.
Measles and mumps are infectious viral diseases which can lead to serious complications and potential child death. Though these 2 diseases are vaccine-preventable, re-emergence and recurrent outbreaks are reported worldwide, primarily due to vaccine reluctance and/or non-compliance to recommended vaccination schedules. However, it cannot be excluded that genetic diversity of circulating measles and mumps strains may affect the effectiveness of available MMR vaccines.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Adjusted vaccine effectiveness of at least 1 dose of GSK Biologicals’ measles-mumps-rubella vaccine against measles

Timeframe: The case index date was the date of first diagnosis of measles ascertained either in Clinical Practice Research Datalink (CPRD) or Hospital Episode Statistics (HES) databases. Measles cases were recorded between January 2006 and December 2018.

Adjusted vaccine effectiveness of at least 1 dose of GSK Biologicals’ measles-mumps-rubella vaccine against mumps

Timeframe: The case index date was the date of first diagnosis of mumps ascertained either in CPRD or HES databases. Mumps cases were recorded between January 2006 and December 2018.

Secondary outcomes:

Adjusted vaccine effectiveness of 1 dose of GSK Biologicals’ measles-mumps-rubella vaccine against measles in subjects aged greater than 4 years at index date

Timeframe: The case index date was the date of first diagnosis of measles ascertained either in CPRD or HES databases. Measles cases were recorded between January 2006 and December 2018.

Adjusted vaccine effectiveness of 1 dose of GSK Biologicals’ measles-mumps-rubella vaccine against mumps in subjects aged greater than 4 years at index date

Timeframe: The case index date was the date of first diagnosis of mumps ascertained either in CPRD or HES databases. Mumps cases were recorded between January 2006 and December 2018.

Adjusted vaccine effectiveness of 2 doses of GSK Biologicals’ measles-mumps-rubella vaccine against measles in subjects aged greater than 4 years at index date

Timeframe: The case index date was the date of first diagnosis of measles ascertained either in CPRD or HES database. Measles cases were recorded between January 2006 and December 2018.

Adjusted vaccine effectiveness of 2 doses of GSK Biologicals’ measles-mumps-rubella vaccine against mumps in subjects aged greater than 4 years at index date

Timeframe: The case index date was the date of first diagnosis of mumps ascertained either in CPRD or HES databases. Mumps cases were recorded between January 2006 and December 2018.

Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2019-30-08
Observational study model:
Case-Control
Time perspective:
Retrospective
Clinical publications:
Michael Povey, Emmanuel Aris, Brigitte Cheuvart, Gillian Hall, Catherine Cohet, Corinne Willame, et al. Effectiveness of “Priorix” Against Measles and Mumps Diseases in Children Born After 2004 in the United Kingdom: A Retrospective Case-control Study Using the Clinical Practice Research Datalink GOLD Database. Pediatr Infect Dis J. 2021;40(6):590-596.
Medical condition
Measles
Product
SB208136
Collaborators
Not applicable
Study date(s)
June 2019 to August 2019
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
1 - 13 Years
Accepts healthy volunteers
Yes
  • Cases: Children who were born after 2004 and who were first diagnosed with measles or mumps disease between January 2006 and December 2018.
  • Controls: Children who were born after 2004 and with no diagnosis of measles or mumps disease between January 2006 and December 2018.
  • Subjects vaccinated with any dose of MMR vaccine other than Priorix.
  • Subjects with measles/mumps infection that occurred before 12 months of age.
Inclusion and exclusion criteria
Inclusion criteria:

    Cases: Children who were born after 2004 and who were first diagnosed with measles or mumps disease between January 2006 and December 2018.

    • Controls: Children who were born after 2004 and with no diagnosis of measles or mumps disease between January 2006 and December 2018.
    • Children who were registered continuously in the CPRD database (with sufficient quality of CPRD practice) from 10 months of age up to the index date.
    • Children who had a consultation recorded in the CPRD database (excluding a consultation for vaccination) in the year prior to the index date.
Exclusion criteria:

    Subjects vaccinated with any dose of MMR vaccine other than Priorix.

    • Subjects with measles/mumps infection that occurred before 12 months of age.
    • *Subjects were excluded if they were linked to more than 1 HES record or if several subjects were linked to the same HES record. *Criterion reworded as compared to protocol for clarification.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2019-30-08
Actual study completion date
2019-30-08

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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