Sixty-eight Saudi children, 17 to 19 months of age were enrolled in a study to evaluate the safety and immunogenicity of Hemophilus influenzae type B capsular polysaccharide diphtheria toxoid (PRP-D) conjugate vaccine. Adverse reactions to the vaccine were determined through a questionnaire administered to the parents. Local and systemic reactions to the vaccine were mild and resolved within 24 to 48 hours. PRP antibody levels were measured prior to and one to two months following immunization. PRP antibody levels in the pre-immunization sera of 77% of subjects were below the level associated with immediate protection (≥0.15 μg/ml), and 88% were below the level associated with long-term protection (≥1 μg/ml) from Hemophilus influenzae type B (HIB) disease. After one dose of PRP-D vaccine, 100% of recipients achieved antibody levels of ≥0.15 μg/ml, and 85% achieved levels of ≥1 μg/ml. The geometric mean level of antibody after immunization (5.66 μg/ml) was significantly higher than that before immunization (0.098 μg/ml). All subjects had a twofold or greater increase in antibody level in response to the vaccine. We conclude that PRP-D is a safe and highly immunogenic vaccine in this age group of Saudi children. Ann Saudi Med 1993;13(3) Hemophilus influenzae type B (HIB) is the main pathogen causing bacterial meningitis in infants and young children in North America, Europe, and many other parts of the world [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]. Recent studies suggest that HIB is also the most common bacterial pathogen in childhood meningitis in the Kingdom of Saudi Arabia [13][14][15][16]. In addition to meningitis which accounts for more than 50% of cases, HIB can cause other invasive diseases such as bacteremia sepsis, pneumonia, epiglottitis, cellulitis, septic arthritis, and other less common infections [3.5.7-9]. Despite prompt and appropriate antibiotic treatment, the mortality of HIB diseases is still 5% to 10%, with meningitis, epiglottitis, and pneumonia being major causes of death. Serious neurologic sequelae still occur in a proportion of children who survive HIB meningitis [18].Concerns regarding the magnitude and severity of HIB disease have heightened the interest in developing vaccines for prevention of systemic HIB infections in infants and young children. A capsular polysaccharide vaccine (PRP) was introduced in 1985, but its poor immunogenicity restricted its use to children older than 24 months of age [19]. To protect younger infants who are at the highest risk of HIB infection, conjugate vaccines in which the PRP is covalently linked to a protein carrier have been developed [20][21][22]. These conjugate vaccines were found to be immunogenic and protective when administered to young infants in large scale studies [22][23][24][25][26][27][28][29][30][31][32].Studies with conjugate vaccines have largely involved infants and children in industrialized countries where the vaccines were well tolerated and highly immunogenic. There is evidence, however, that the genetic backgro...