The introduction of routine Haemophilus influenzae type b conjugate vaccine in Chile: a framework for evaluating new vaccines in newly industrializing countries.

OBJECTIVE

To determine the burden of Haemophilus influenzae type b (Hib) disease, the safety and immunogenicity of Hib conjugate vaccine, the practicality of combining Hib conjugate and diphtheria-tetanus-pertussis vaccines and the effectiveness of routine vaccination.

STUDY DESIGNS

A series of studies were carried out involving infants and children in Santiago, Chile. The study designs included retrospective surveillance, cost-benefit analysis, randomized placebo-controlled trials of safety and immunogenicity and a Phase IV postlicensure evaluation of vaccine effectiveness.

RESULTS

The studies included in this stepwise process showed that Hib invasive disease was a significant public health problem with a substantial economic burden; that combining Hib conjugate and diphtheria-tetanus-pertussis vaccines was practical, safe and elicited a strong immunologic response; and that the combined formulation afforded a high level of protection against invasive Hib disease (90% effectiveness).

CONCLUSIONS

In July, 1996, Chile became only the third newly industrializing country to introduce routine Hib conjugate vaccination. New vaccines, such as Hib conjugates, will be more expensive than existing ones. The stepwise process used in Chile may serve as an example for the evaluation of new vaccines in nonindustrialized countries.