Transmission of pneumococcus within family units (TOP study)
Research type
Research Study
Full title
Evaluation of the relationship between pneumococcal colonisation density in 2-year-old children and rates of transmission to family contacts using live attenuated intranasal influenza vaccine as a probe. A randomised prospective step-wedge multicentre study.
IRAS ID
227810
Contact name
Adam Finn
Contact email
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Pneumococcus is a bacterium that frequently lives in the noses of young children without causing any illness. Occasionally, it causes disease like ear infections and pneumonia (chest infection) and very rarely meningitis (infection around the surface of the brain). Viral infections, like flu, seem to help pneumococcus to spread from one person to another and may contribute to these diseases. Flu is a common viral illness spread by coughing, sneezing and direct contact that causes sore throat, cough, fever, runny nose and muscle aches.
The 2-year-old child in each family enrolled will receive one dose of the flu vaccine that is routinely offered to children in the UK. It is given as a spray into the nose and contains weakened live flu viruses that do not cause flu but can induce a response from children’s immune systems which protects them from getting flu and from passing it on to others.
We want to study the interaction between the flu viruses from the vaccine and the bacteria that normally live in children’s noses. Previous research suggests the nasal flu vaccine may temporarily increase the numbers of bacteria in children’s noses without increasing their likelihood of getting sick. We want to find out whether children with higher numbers of bacteria in their noses after the administration of the nasal flu vaccine are more likely to pass them on to other family members.
We will take saliva samples and nose swabs from the 2-year-old and all participating family members at each of 5 study visits between September and December to track the spread of bacteria within the family. Participants will also be asked to complete a contact survey at each visit. Each family will be involved in the study for about three months, and all visits will be carried out as home visits.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0190
Date of REC Opinion
6 Sep 2017
REC opinion
Further Information Favourable Opinion