Poliomyelitis Infections and Infestations
Conditions
Interventions
The trial is pragmatic in aiming to provide data which will reflect the future use of ID fIPV in campaign and cVDPV type 2 outbreak control. Under such circumstances, the vaccine will be offered unive
Sponsors
MRC Unit The Gambia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written or thumb-printed informed consent obtained from a child's parent or guardian 2. Resident within the geographical area which is expected to be covered by the campaign 3. Between 4 and 59 months of age at the time of the campaign
Exclusion criteria
Exclusion criteria: 1. Anaphylaxis or a severe, potentially life threatening, allergic reaction to a previous vaccination 2. Any other condition or significant acute illness meaning that it is judged to be against the infant's or child's best interests to receive ID fIPV (note that most chronic illnesses and minor acute illnesses - when normal vaccinations would be encouraged, do not represent exclusions for the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total time taken to deliver ID fIPV using each of the three methods of administration; also sub-divided into key components of the procedure (e.g. injection preparation, infant or child preparation, injection delivery) 2. Number of ID fIPV doses delivered using each of the three methods in the course of a defined campaign day by one vaccination team 3. Qualitative measures of administration method utility including training requirements as collected through structured questionnaires and through focus groups (data collected separately for vaccinators and the parents/guardians of vaccinated infants and children) 4. Local and systemic reactogenicity on day 3 following ID fIPV. Home visits conducted by trained field staff. Data collected according to standardized proforma 5. Serious adverse events (SAE) and adverse events (AE) in the 4 weeks following ID fIPV administration 6. Semi-quantitative measure of distress in infants and children associated with ID fIPV administration 7. Storage volumes and weights of equipment required for ID fIPV delivery and subsequent bio-waste disposal including any differences the equipment required to safely deliver such vaccinations in a campaign 8. Number of ID fIPV doses deliverable per IPV vial using each of the three administration methods (to identify any wastage associated with syringe/device filling) 9. Immune response to ID fIPV measured using polio neutralization assays conducted by the CDC, USA, at 4 to 6 weeks after the campaign 10. Changes in both the time taken to deliver the ID fIPV and in the immune responses generated over the course of a 3-day campaign (to identify the number of doses administered before each of these elements are achieved optimally for each of the given ID fIPV administration methods) 11. Changes in the vaccine vial monitors (VVM) and also temperature deviations identified using a continuous temperature data logger associated with a campaign using each of the three administration methods 12. Qual | — |
Countries
Gambia
Contacts
Public ContactEd Clarke
Outcome results
None listed