A Campaign-based ID fIPV Administration Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02967783
• Date of registration: 19/09/2016
• Prospective Registration: Yes
• Primary sponsor: Medical Research Council Unit, The Gambia
• Public title: A Campaign-based ID fIPV Administration Trial
• Scientific title: A Pragmatic Trial to Quantitatively and Qualitatively Assess Different Techniques for the ID Administration of Fractional Dose IPV in a Campaign Setting in The Gambia
• Date of first enrolment: February 7, 2017
• Target sample size: 2721
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02967783
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Gambia

Contacts

• Name: Adedapo O Bashorun, MBBS
• Affiliation: MRC Unit The Gambia

• Name: Ed Clarke, MRCPCH MSc PhD
• Affiliation: MRC Unit The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written or thumb-printed informed consent obtained from a child's parent or guardian

- Resident within the geographical area which is expected to be covered by the campaign

- Between 4 and 59 months of age at the time of the campaign

Exclusion Criteria:

- Anaphylaxis or a severe, potentially life threatening, allergic reaction to a previous
vaccination

- 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: 4 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Device: Needle and syringe

Device: ID adaptor

Device: ID Jet Injector (Tropis, Pharmajet)

Primary Outcome(s)

Qualitative factors which might influence campaign uptake in The Gambia and comparable sub-Saharan African settings [Time Frame: 1 week following vaccination campaign]

Number of ID fIPV doses delivered using each of the three methods in the course of a defined campaign day by one vaccination team [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Qualitative measures of administration method utility [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Storage volumes 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 [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Changes in the time taken to deliver the ID fIPV and in the immune responses generated over the course of a 3 day campaign [Time Frame: Over 3 days of the campaign]

Semi-quantitative measure of distress in infants and children associated with ID fIPV administration [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Serious adverse events (SAE) and adverse events (AE) following ID fIPV administration [Time Frame: Within 4 weeks of vaccination]

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 [Time Frame: Over 3 days of the campaign]

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) [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Immune response to ID fIPV (poliovirus neutralization assays) [Time Frame: Serum sample taken at baseline (pre-vaccination) and 4 weeks following vaccination]

Local and systemic reactogenicity collected according to standard severity score (0 - 4) system. [Time Frame: Day 3 following vaccination]

Total time taken to deliver ID fIPV using each of the three methods of administration [Time Frame: Collected on day 1, 2 or 3 of the vaccination campaign]

Secondary ID(s)

SCC1495

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

World Health Organization

Centers for Disease Control and Prevention