Table 2.

Target product profile of a capsule conjugated Campylobacter or other injectable vaccine for global use.

Variable	Traveler population to LMI Countries	Children up to 5 years of age in LMI Countries
Indication	Prevention of moderate to severe illness due to Campylobacter jejuni in travelers from high income countries	Prevention of moderate to severe diarrhea due to Campylobacter jejuni in children less than two years of age.
Target Population	Adults 18 – 65 years	Children up to 5 years of age.
Schedule and Route of Administration*	Optimal: 1 dose IM route. Acceptable: 2 dose IM route 28 days or less	Optimal: EPI schedule – 1 dose IM route. Acceptable: EPI schedule: 2 or 3 dose + booster IM route.
Safety	Safety and reactogenicity profile should be clinically acceptable. Contraindications should be restricted to know hypersensitivity to any of the vaccine components
Efficacy*	70% efficacy against moderate to severe illness caused by all C. jejuni strains	Optimal: 70% efficacy against moderate to severe illness caused by all C. jejuni strains Acceptable: 50% efficacy against moderate to severe illness caused by C. jejuni strains in the vaccine
Duration of Protection	Optimal: lifetime Acceptable: 2 years	Optimal: To 5 years. Acceptable: 2 years, w/boosting possible to extend protection
Cost per regimen	$75 – 100	$1 – 3
Co-administration	With travel vaccines without interference	With EPI vaccines without interference
Vaccine volume	0.5 ml/dose
Target Countries	US, Europe, Japan, Australia, New Zealand and other HDI countries	GAVI-eligible and LMIC
Onset of immunity	1–2 weeks after primary series	2 weeks after vaccine series
Indirect protection	No	Yes, ideally
Protection against chronic health sequelae	Yes (functional bowel disorders, reactive arthritis, GBS)	Yes (environmental enteropathy, GBS)