Time and Motion (T&M) Study of Hexavalent Vaccines
Research type
Research Study
Full title
Time and Motion (T&M) Study of Hexavalent Vaccines (Vaxelis vs. Infanrix Hexa) in a General Practitioner (GP) Surgery Setting in the United Kingdom (UK)
IRAS ID
317645
Contact name
Gordon Irvine
Contact email
Sponsor organisation
Sanofi
Clinicaltrials.gov Identifier
000, 000
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Two hexavalent vaccines are currently used within the paediatric immunisation programme, i.e., Infanrix Hexa and Vaxelis, which both protect against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type B and hepatitis B. Infanrix Hexa requires reconstitution before administration, whereas Vaxelis does not require reconstitution before administration.
The purpose of this study is to compare the time needed to perform a paediatric immunisation with a vaccine that requires reconstitution before administration (Infanrix Hexa) or a vaccine that is in a pre-filled syringe, ready to use (Vaxelis). This is done by recording the time Health Care Practitioners (HCP) need to complete paediatric immunisations with either Infanrix Hexa or Vaxelis.
In addition, we will assess the occurrence of immunisation errors and vaccine wastage, and might ask HCPs to complete a survey to assess their satisfaction and preference with regard to paediatric immunisation with Infanrix Hexa and/or Vaxelis after their last observed immunisation within the study.
This study will be conducted within GP surgeries within the United Kingdom, observing HCPs administering routine paediatric immunisations to infants aged 8, 12 and 16 weeks of age.
Each participating site is expected to be involved for approximately four months, including a data collection period of two months.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0039
Date of REC Opinion
23 Mar 2023
REC opinion
Further Information Favourable Opinion