A UK immunogenicity & safety study comparing 2 dTpa-IPV vaccines
Research type
Research Study
Full title
A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when coadministered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children
IRAS ID
38813
Contact name
Adam Finn
Sponsor organisation
GSK
Eudract number
2009-012202-39
ISRCTN Number
Not applicable
Research summary
The current UK routine immunisation programme recommends a preschool booster of diphtheria, tetanus, a cellular pertussis and poliomyelitis between the ages of 3 years 4 months and 5 years. This is normally administered at the same time as the second dose of the mumps, measles and rubella (MMR) vaccine. This is a European Medicines Evaluation Agency (EMEA) mandated study to support a change to the licensed age range for GSK Biologicals dTpa-IPV vaccine. It is a randomised trial but open label - participants will know which vaccine they receive. We will recruit 384 children between the ages of 3 and up to the day before their 5th birthday. There are two groups: The treatment group will receive a booster dose of the GSK Biologicals dTpa-IPV vaccine (Boostrix Polio) with their second dose of MMR vaccine. The control group will instead receive a booster dose of the routine SanofiPasteurMSD dTpa-IPV vaccine (Repevax) with their second dose of MMR vaccine. This study will evaluate the immunogenicity and safety of a booster dose of GSK Biologicals dTpa-IPV vaccine in healthy 3 and 4 year old children compared to the SanofiPasteurMSD dTpa-IPV vaccine when co-administered with a booster dose of the MMR vaccine.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
10/H0206/43
Date of REC Opinion
10 Nov 2010
REC opinion
Further Information Favourable Opinion