Trial Information

Summary: A Study for an Investigational Comination Vaccine for Healthy Infants

Some Information about Combination Vaccines:

Vaccines protect children from disease but the current childhood immunization guidelines call for up to 22 different injections (shots) in the first 15-18 months of life, with as many as 5 injections given at a single visit. Combination vaccines allow children to receive fewer shots while still being protected against the same number of diseases. An example of a combination vaccine that is already licensed is the MMR vaccine for measles, mumps and rubella. The investigational vaccines in this study combine 4 or 5 of the usual vaccinations into one shot. They contain diphtheria, tetanus, acellular pertussis (Dtap) and inactivated poliovirus (IPV), with or without Haemophilus influenzae type b (Hlb).

What is the purpose of the study???

The purpose of this study is to further test the safety and effectiveness of two investigational combination vaccines, when used in immunization schedules with other vaccines and given to healthy infants. The investigational combination vaccines will be compared to licensed vaccines to see if there are any differences. Combination vaccines may not work as well as getting the vaccinations separately and that is why we can't just mix the shots together. A lot of research has to go into making sure combination shots are safe and that they work well.

How will being involved in this study potentially benefit me or my family??? Your child will have the benefit of being immunized with vaccines against Hib, diphtheria, tetanus, pertussis, poliovirus, pneumococcus, measles, mumps, rubella, hepatitis B and varicella. The investigational combination vaccines in this study have been licensed and used in Canada, where over 10 million doses have been given since 1997. However since the study combination vaccines (involving DPT, Hlb and polio) are not licensed in the United States, no claims to their effectiveness can be given. By allowing your child to participate in the study you may be helping the advancement and development of combination vaccines for infants and toddlers.

How do I find out more information about enrolling myself or other members of my family???

The study will be explained to you in more detail and you will find out if your baby is eligible to be enrolled in the study. If your baby is eligible and you are interested in participating in the study, an informed consent will be provided. Study participants will receive reimbursement for time and travel. Please call:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.