The FDA approved Pediarix for protection against diphtheria, tetanus, pertussis, hepatitis B and polio (news - web sites) in infants 2, 4 and 6 months of age, the UK company said, resulting in up to six fewer injections under the current recommended schedule.

At present, the company noted that children receive approximately 20 injections in the first two years of life, including nine shots to protect against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio alone. Pediarix was developed to protect against these diseases with only three injections, easing the burden on parents and doctors to comply with the recommended vaccination schedule, the company said.

"The introduction of a combination vaccine like Pediarix marks a milestone for the United States immunization program," said Dr. Joel Ward of the University of California in Los Angeles, who served as the principal clinical trial investigator.

GlaxoSmithKline said Pediarix was proven safe and effective in numerous worldwide clinical trials, involving 7,028 infants who received a total of 20,739 doses.

The administration of Pediarix was associated with higher rates of fever relative to separately administered vaccines, the company added. But the most common side effects were similar to the other vaccines, such as injection-site reactions, fever and fussiness, the drugmaker said.

GlaxoSmithKline spokeswoman Ramona DuBose told Reuters Health the company plans to launch the vaccine in early January and would market it at a price comparable to the total cost of the individual vaccines.

GlaxoSmithKline estimated that about 3 million infants in the US would qualify for the vaccination and predicted that further development of such combination vaccines may also make it easier to add new vaccines to the immunization schedule.