TABLE 4.12 Selected Vaccines in Development

Product and Company U.S.

Development Status

Adenohepatitis B virus vaccine

Phase I

Wyeth-Ayerst

 

Acellular pertussis vaccine

Phase I/II

Massachusetts Department of Public Health

 

Acellular pertussis component

Phase I

Michigan Department of Public Health

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed

Phase III (infant efficacy study)

Lederle-Praxis Biologicals

 

Diphtheria and tetanus toxoids and acellular pertussis vaccine, adsorbed

Phase III

North American Vaccine

 

Diphtheria and tetanus toxoids and accellular pertussis vaccine, adsorbed and inactivated polio vaccine

Phase III

North American Vaccine

 

TetrammuneTM Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed, and Haemophilus influenzae type b vaccine

PLA submitted (recommended for approval by FDA advisory committee, ages 2 months up to 7th birthday)

Lederle-Praxis Biologicals

 

Diptheria and tetanus toxoids and acellular pertussis vaccine, adsorbed, and Haemophilus influenzae type b conjugate vaccine

Phase II (for booster dose at 15–18 months of age or when both vaccines recommended to be given simultaneously)

Lederle-Praxis Biologicals

 

PropediaTM Diphtheria and tetanus toxoids and pertussis vaccine, adsorbed and Haemophilus influenzae type b vaccine (diphtheria toxoid conjugate)

PLA submitted (for 15–60 months of age as final booster dose in Hib series or as n single dose primary immunization at 15–60 months of age)

Connaught Laboratories, Inc.

 

Act HIBTM + DTP; Diptheria and tetanus toxoids Act HIB and pertussis vaccine, adsorbed, reconstituting Haemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)

Submitted as part of PLA for alone (for 2–60 months of age)

Connaught Laboratories, Inc./Pasteur Mérieux Sérums et Vaccins

 

Act HIBTM + DTaP; Diptheria and tetanus toxoids and acellular pertussis vaccine, adsorbed, reconstituting Haemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)

Phase II for 15–60 months of age

Connaught Laboratories, Inc./Pasteur Mérieux Sérums et Vaccins



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