TYPHIM Vi Rx

A randomized double-blind controlled trial with Typhim Vi vaccine (liquid formulation) was conducted in 5 villages west of Kathmandu, Nepal.

• 3454 received Typhim Vi; 3454 in the control group received 23-valent pneumococcal polysaccharide vaccine.
• Study included 6439 individuals 5 to 44 years old, 165 children 2 to 4 years old and 304 adults over 44 years old.
• Overall protective efficacy of Typhim Vi vaccine was 74% (95% CI, 49-87) for blood culture confirmed cases of typhoid fever during 20 months of post-vaccination follow-up.

The protective efficacy of the Typhoid Vi Polysaccharide Vaccine, lyophilized formulation, was evaluated in a randomized double-blind controlled trial conducted in South Africa.

• 5692 children received Vi capsular polysaccharide vaccine; 5692 in the control group received meningococcal polysaccharide (Groups A+C) vaccine.
• The protective efficacy for the Vi capsular polysaccharide (lyophilized formulation) group for blood culture confirmed cases of typhoid fever was 55% (95% CI, 30-70) overall during 3 years of post-vaccination follow-up, and was 61%, 52% and 50%, respectively, for years 1, 2, and 3.

Efficacy studies were not feasible in a US population because of the low incidence of typhoid fever. Immunogenicity and safety trials were conducted in an adult US population. A single dose of Typhim Vi vaccine induced a 4-fold or greater increase in antibody levels in 88% and 96% of this adult population for 2 studies, respectively, following vaccination.

Concurrently Administered Vaccines

• Double-blind, randomized, controlled clinical trial.
• 945 participants aged 18 through 55 years.
• Study participants received Typhim Vi and Menactra vaccines concomitantly (n=469), or Typhim Vi vaccine followed 1 month later by Menactra vaccine (n=476).
• Sera were obtained approximately 28 days after each respective vaccination.
• Antibody response to Typhim Vi vaccine and to Menactra vaccine components were similar between groups.