Status: marketed in Europe and internationally

Organizations involved:

Sanofi Pasteur S.A – Manuf.; R&D; Tech.; Intl. mark.; Parent

Sanofi Pasteur MSD – Europe mark

Cross ref: See the entries for Diphtheria, Pertussis Toxoids and Polio Vaccine Products. See the dTpa-IPV booster/Sanofi (Repevax) entry for further informatio about the diphtheria, tetanus and trivalent inactivated poliovirus components of this vaccine.

Description: Revaxis is an aqueous formulation combining diphtheria, tetanus and trivalent inactivated poliovirus vaccine with aluminum hydroxide as adjuvant.

Each dose (0.5 ml) contains: purified diphtheria toxoid, not less than 2 IU (5 Lf); purified tetanus toxoid, not less than 20 IU (10 Lf); inactivated poliomyelitis virus type 1, 40 D antigen units; inactivated poliomyelitis virus type 2, 8 D antigen units; inactivated poliomyelitis virus type 3, 32 D antigen units, aluminium hydroxide as adsorbant/adjuvant 0.35 mg (as aluminium); packaged as a suspension for injection in pre-filled syringes. The polio viruses are cultured in Vero cells (African green monkey kidney cells). Excipients include phenoxyethanol; formaldehyde; Medium 199, and Water for injections. Medium 199 is a complex medium of amino acids, mineral salts, vitamins, polysorbate 80 (Tween 80) and other substances diluted in water for injections. The is store at 2°C to 8°C (refrigerated) with a shelf life of 3 years.

Companies.: Revaxis was developed and is manufactured by Sanofi Pasteur S.A., CBER/FDA est. no. 1724. It is marketed in Europe by Sanofi Pasteur MSD, a joint venture of Sanofi Pasteur and Merck, and and internationally by Sanof Pasteur S.A.

Indications: [Full text of the " Therapeutic indications: " section of the U.K. SPC]:

REVAXIS is indicated for active immunisation against diphtheria, tetanus and poliomyelitis in children from six years of age, adolescents and adults as a booster following primary vaccination.

REVAXIS is not intended for primary immunisation.

Status: The vaccine is approved in the U.K. (apparently launched in 1996) and various other European countries and internationally.

Trials: During clinical studies, the immunogenicity of Revaxis was evaluated in 661 healthy subjects aged six to 78 years. In subjects vaccinated within 10 years of a previous dose of diphtheria/tetanus/poliomyelitis vaccine, more than 99% achieved protective antibody levels for diphtheria, tetanus and poliomyelitis (types 1, 2 and 3) one month after receiving Revaxis.

In a clinical study in 113 healthy subjects aged 40 to 78 years who received their last vaccination against diphtheria, tetanus and poliomyelitis more than ten years ago, Revaxis elicited a satisfactory booster response.

Antibody persistence over a two-year period was assessed in 113 healthy adults. Two years after receiving a dose of Revaxis, the proportions of subjects with protective titers against diphtheria, tetanus and poliomyelitis (types 1, 2 and 3) were 100%, 94.7% and 100% respectively.

In a clinical study in 151 healthy children aged six to nine years, antibody titres at one month after a dose of Revaxis were ~3-fold higher than those seen in the healthy adults at two years post-dose. Therefore, it was presumed that antibody levels in children would be at least as good as those observed in adults at two years post-dose.

Medical: The dose for children from the age of six years, adolescents and adults is 0.5 ml by intramuscular injection.

Revaxis contains a low dose of diphtheria vaccine and is therefore not suitable for use in children 6 years of age or younger (full strength diphtheria-containing vaccine should normally be used in children up to the age of 10)