Measles-Rubella Microarray Patch (MR-MAP) Target Product Profile.
| Format: | eBook |
|---|---|
| Language: | English |
| Published: |
Geneva :
World Health Organization,
2020.
|
| Edition: | 1st ed. |
| Subjects: | |
| Online Access: | Click to View |
Table of Contents:
- Intro
- Contents
- Preface
- Acknowledgements
- Abbreviations
- 1. Introduction
- 2. General considerations for an MR vaccine delivered by MAPs
- Indication
- Use-case scenarios
- Dose regimen and schedule
- Formulation
- Presentation
- 3. Generic product characteristics for an MR vaccine on solid coated or in dissolvable MAPs
- Target population
- Target countries
- Safety
- Immuno-genicity
- Stability
- Vaccine vial monitors (VVM)
- Dosage
- 4. Generic product characteristics for MAPs for delivery of MR vaccines
- Product registration path
- Dose presentation
- Primary and secondary packaging
- Tertiary packaging
- Labelling
- Route of administration
- Human factors (HF)
- Application
- User training requirements
- Delivery time: time required to apply the MAP
- Wear time: minimal time that the MAP must be worn for the entire dose of the vaccine to be success-fully delivered
- Delivery: indication of a successful vaccination
- Delivery: application site
- Reactogenicity
- Cost per immunized child
- Disposal.