A trial to assess the practicality of delivering fractional doses of an inactivated poliovirus vaccine in a community-based campaign in under 5 year-olds in a rural setting in The Gambia

• Register: ISRCTN
• Last refreshed on: 2 October 2017
• Main ID: ISRCTN93905494
• Date of registration: 14/09/2016
• Prospective Registration: Yes
• Primary sponsor: MRC Unit The Gambia
• Public title: A trial to assess the practicality of delivering fractional doses of an inactivated poliovirus vaccine in a community-based campaign in under 5 year-olds in a rural setting in The Gambia
• Scientific title: A pragmatic trial to quantitatively and qualitatively assess different techniques for the intradermal administration of fractional dose inactivated poliovirus vaccine in a campaign setting in The Gambia
• Date of first enrolment: 15/10/2016
• Target sample size: 2700
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN93905494
• Study type: Interventional
• Study design: Single-centre pragmatic randomized open-label trial with allocation concealment (Prevention)

Countries of recruitment

Gambia

Contacts

• Name: Ed Clarke

Key inclusion & exclusion 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: 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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Poliomyelitis
Infections and Infestations

Intervention(s)

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 universally within the target age group. In addition, when considering the induction of seroprotection against poliovirus, the administration of ID fIPV is of proven benefit and the intervention is of minimal risk beyond the risks associated with any routine vaccination. For these reasons the eligibility criteria are intentionally inclusive.

Arm 1: 0.1 ml inactivated poliovirus vaccine (IPV) administered as a single dose intradermally by needle and syringe
Arm 2: 0.1 ml inactivated poliovirus vaccine (IPV) administered as a single dose intradermally by needle and syringe with an Intradermal adaptor (West)
Arm 3: 0.1 ml inactivated poliovirus vaccine (IPV) administered as a single dose intradermally using a disposable syringe jet injector (Tropis, Pharmajet)

Three days later a member of the study team visits the children at home to ask some questions and look at the site on the child’s arm where the injection was given. They also check the child’s temperature. If the child is unwell in the four weeks after this the team provides any treatment that is needed. After four weeks those children aged over 2 years who had a blood test the first time have a second blood test. The blood tests measure the amount of protection from polio the child has. All parents are contacted at this point to see that their children are well.

Primary Outcome(s)

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. Qualitative factors which might influence campaign uptake in The Gambia and comparable sub-Saharan African settings (data collected from public health officers, regional health and EPI personnel as well as from the parents/guardians of vaccinated infants and children and other community leaders and community members)

Secondary ID(s)

SCC1495

Source(s) of Monetary Support

World Health Organization