Polio Sabin One and Three

/ GSK

One dose of vaccine is delivered in 2 drops (multidose container) from the polyethylene dropper supplied with the glass vial.
The vaccine may be administered alone or mixed with beverages or foods provided these do not contain substances that may inactivate polioviruses, such as preservatives. Suitable vehicles are simple syrup, milk, bread and a lump of sugar. Since the vaccine has a bitter salty taste, it may be given in syrup or on a lump of sugar, particularly when it is to be given to young children.
The vaccine should be administered to breastfed infants, preferably two hours before or after breastfeeding in order to avoid contact with the antibodies present in the breast milk.
Care should be taken not to contaminate the dropper with saliva of the vaccinee.

Active immunization of infants and susceptible children and adults against infection caused by polioviruses of type 1, 2 and 3.

Subjects suffering from acute severe febrile illness, or persisting diarrhea or vomiting. Known systemic hypersensitivity to neomycin or polymyxin or to any other component of the vaccine. However, a history of contact dermatitis to neomycin or polymyxin is not a contra-indication. Subjects suffering from primary and secondary immunodeficiencies.

It is good clinical practice to offer immunization to presumably susceptible close contacts. Lower seroconversion rates after vaccination have been observed in some populations and groups of vaccinees. All three vaccine viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the vaccine. Previous vaccination with IPV is not a contra-indication. Symptomatic and asymptomatic infection with human immunodeficiency virus does not contra-indicate immunization. Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee. Should under no circumstances be injected.
Pregnancy and lactation: Should not be given to pregnant women unless they are exposed to a definite risk of infection with wild polioviruses. The effect on breastfed infants has not been evaluated.

Very rare allergic reactions have been reported.

This product (oral) can be administered at the same time as Haemophilus influenzae Type b vaccine, hepatitis B vaccine, diphtheria, pertussis and/or tetanus vaccine, measles, rubella and/or mumps vaccine, or BCG vaccine if this fits into the vaccination schedule.
Concomitant administration of oral poliomyelitis vaccine (OPV) and rotavirus vaccine does not affect the immune response to the polio antigens but may slightly reduce the immune response to rotavirus vaccine. A clinical study in which OPV was co-administered with GlaxoSmithKline Biologicals’ rotavirus vaccine (Rotarix) showed that clinical protection against severe rotavirus gastro-enteritis was maintained. If  it (oral) cannot be given at the same time as other live attenuated vaccines, an interval of at least one month should be left between both vaccinations. Immunosuppressive treatment may reduce the immune response, may favour the multiplication of the vaccine viruses and may increase the length of excretion of the vaccine viruses in the stools.

Pregnancy: Although there is no evidence that live attenuated polioviruses have an adverse effect on the foetus, in accordance with general principles, the vaccine should not be given to pregnant women unless they are exposed to a definite risk of infection with wild polioviruses.
Non immune woman of child-bearing age should use contraception during 3 months following vaccination.
Lactation: The effect on breastfed infants of the administration of POLIO SABINTM (oral) to their mothers has not been evaluated in clinical studies. No known contra-indication has been established. The vaccine may be administered to a lactating mother.

Occasional reports of overdose have been received. Overdose has not resulted in ill-effects.