Streptococcus pneumoniae (Sp), Haemophilus influenzae (Hi) and Moraxella catarrhalis (Mc) Infections and Infestations
Conditions
Interventions
This is a step-wedge design so that both index children of group 1 and group 2 (randomly allocated at a 1:1 ratio) receive the standard dose of LAIV but at different times. The group number determines
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female child 2. Who will be 2 years of age between 1st January and 31st August of the year of recruitment 3. Who is resident near the recruiting centres 4. Who have at least two other people, either adults or children, resident in the house where they live that are willing and able to take part
Exclusion criteria
Exclusion criteria: Exclusion criteria include all contra-indications in the vaccine licence, in addition: 1. Children currently enrolled in another clinical trial or study which, in the opinion of the investigator might interfere with their likelihood of completing either or both studies or which might confound outcomes of either study. Families participating in the first year of the study who have another child of the right age and are otherwise eligible and who wish to participate again in the second year will be permitted to do so 2. Confirmed or suspected primary or secondary immunodeficiency OR known to be severely immunosuppressed due to any condition or recent (in the last 6 months) therapy (eg leukaemia, HIV infection, organ or bone marrow transplant) 3. Severely immunocompromised household member or close contact (because of potential for transmission of live attenuated virus) 4. Receipt of immunosuppressants or immune modifying drugs including oral or parenteral steroids (at a dose equivalent of prednisolone >0.5mg/kg/day for more than 1 week within the 3 months prior to enrolment). Inhaled steroids are not a contraindication (although see below re asthma and wheezing) 5. Current hospital-based management of asthma 6. Previous receipt of, or intended immunisation with any other influenza vaccine(s) 7. Children who are in risk groups for severe influenza (e.g. chronic respiratory (but for severe asthma see above), cardiac, renal, hepatic or neurological diseases and diabetes) can be enrolled and immunized in the study provided they are eligible to receive LAIV following the guidance published in the Green Book (ref: www.gov.uk/government/uploads/system/uploads/attachment_data/file/456568/2904394_Green_Book_Chapter_19_v10_0.pdf) 8. Children with other chronic, stable medical illnesses that do not result in immunosuppression and are not risk groups indicating receipt of seasonal flu vaccine (e.g. epilepsy, metabolic disorders) may participate in the study, unless their condition or circumstances will in some way interfere with the completion of study procedures 9. Children receiving salicylate therapy (Aspirin) 10. Previous anaphylactic reaction to any component of the nasal flu vaccine (including gelatine or gentamicin), or to eggs or egg proteins (eg ovalbumin) 11. Any other condition or circumstances which, in the opinion of the investigator, might put the index subject or family members or research team members at risk or which might interfere with the likelihood of successful of study procedures and sampling per protocol or which might prevent the results obtained from contributing in any way with successful achievement of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Streptococcus pneumoniae carriage and transmission events in family units measured using real-time PCR on serial nasopharyngeal and saliva samples taken every 2 weeks over an 8-week period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Haemophilus influenzae carriage and transmission events in family units measured using real-time PCR on serial nasopharyngeal and saliva samples taken every 2 weeks over an 8-week period. 2. Moraxella catarrhalis carriage and transmission events in family units measured using real-time PCR on serial nasopharyngeal and saliva samples taken every 2 weeks over an 8-week period | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Oliver
Outcome results
None listed