INACTIVATED POLIOMYELITIS VACCINE (DIPLOID CELL ORIGIN) - IPV

Connaught

Poliomyelitis Prophylaxis

Pharmacology: The clinical data for Inactivated Poliomyelitis (Diploid Cell Origin) - IPV were obtained from 2 centres: one in Canada (British Columbia) and the other in the U.S. (Baltimore, Maryland). Serum samples from both sites were tested for neutralizing antibody to poliovirus type 1, 2 and 3 by micro metabolic inhibition test at Connaught Laboratories Limited.

The clinical trial data on 3 lots of IPV obtained from a study on 338 infants in British Columbia demonstrated that 2 injections of vaccine at an interval of 2 months administered to infants 2 months of age at the time of the initial injection were effective in stimulating an antibody response to each of the three poliovirus types.

The response to Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV developed despite the presence of maternally transmitted antibody in most of the infants at the time of the intitial vaccine injection. Following the second injection of vaccine detectable antibody (³1:4) was present 99.7% (of 329 children) for Types 1 and 2 and in 98.8% (of 329 children) for Type 3.

In 294 children, the third vaccine injection at 15 to 18 months of age stimulated antibody rises to each of the 3 virus types to levels much higher than those attained following the second injection. The geometric mean responses 1 month after the third dose were 1:1 922, 1:4 010 and 1:1 388 for poliovirus types 1, 2 and 3 respectively.

The data obtained in Baltimore trials in a group of 254 infants demonstrated that 2 injections of vaccine at an interval of 2 months administered to infants 2 months of age at the time of the initial injection were effective in stimulating an antibody response to each of the 3 poliovirus types. Following the second vaccine injection detectable antibody (³1:4) to Type I poliovirus was present in 98.8% of infants and antibody (³1:4) to Type 2 and 3 poliovirus was present in 99.2% of infants.The response to vaccine developed despite the presence of maternally transmitted antibody in a high percentage of the infants at the time of the initial vaccine injection.

Indications: The vaccine is an active immunizing agent to be administered, as described below, for the prevention of poliomyelitis.

Contraindications: Immunization with Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV should be deferred in the presence of acute febrile illness including respiratory infections.

Warnings: The vaccine should be perfectly clear and colorless. Any vaccine showing particulate matter or turbidity should be discarded.

Precautions: Inactivated Poliomyelitis Vaccine is the vaccine of choice for immunizing immunodeficient patients and their household contacts. Although patients with immune deficiency diseases such as combined immunodeficiency, hypogammaglobulinemia and agammaglobulinemia, those with altered immune states due to diseases such as leukemia, lymphoma or generalized malignancy and those with immune systems compromised by therapy with corticosteroids, alkylating drugs, antimetabolites or radiationmay not develop a protective immune response, Inactivated Poliomyelitis Vaccine should be administered. Because of the possibility of immunodeficiency in other members of a household in which there has been one such case, Inactivated Poliomyelitis Vaccine should be used to immunize subsequent children until the immune status of the recipient and of other children in the family is documented.

Since the vaccine contains trace amounts of animal protein and may contain trace amounts of streptomycin and/or polymyxin B and neomycin, the possibility of allergic reactions in individuals sensitive to these substances should be borne in mind when considering the use of this vaccine.

As with any biological product, epinephrine HCl solution 1:1 000 should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.

Pregnancy: Although there is no convincing evidence documenting adverse effects of inactivated poliomyelitis vaccine on the pregnant woman or the developing fetus, it is prudent on theoretical grounds to avoid vaccinating pregnant women.

Adverse Effects: Local reactivity at the injection site as observed during the Canadian clinical trials consisted of redness, hardness and pain or discomfort occurring in 14%, 4% and 12% of vaccinees, respectively, usually on the evening following injection and declining thereafter to minimal levels.

As both of the first and second Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV vaccine injections were administered at the same time, but at a different site from the first and second injections of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DPT Adsorbed), interpretation of systemic reactivity cannot be attributed solely to either vaccine. However, the systemic reactivity associated with administration of DPT Adsorbed in previous clinical trials would tend toindicate that the DPT Adsorbed was the major contributory factor.

Dosage: Primary immunization of infants at or above the age of 2 months, and children up to their 7th birthday: 3 doses of 0.5 mL each should be administered s.c. at intervals of 8 weeks, followed by a fourth dose of 0.5 mL, approximately 12 months after the third dose.

In infancy the primary schedule is usually integrated with DPT Adsorbed immunization, beginning at 8 to 12 weeks of age.

Primary immunization of older children (after their 7th birthday) and adults: 2 doses of 0.5 mL each administered s.c. 8 weeks apart, followed by a third dose of 0.5 mL, approximately 12 months after the second dose.

Booster Doses: All children who have received the initial 4 doses in infancy and in early childhood should be given a booster dose of 0.5 mL of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV before entering school. However, if the fourth primary dose is administered on or after the fourth birthday, a fifth (supplementary) dose is not required at school entry. Further recall doses of 0.5 mL should be given every 10 years thereafter.

Adults: Most adults are already immune and have a very small risk of exposure to poliomyelitis. Immunization is recommended for certain adults who are at greater risk of exposure to poliovirus than the general population, including: travelers to areas or countries where poliomyelitis is epidemic or endemic, laboratory workers handling specimens which may contain polioviruses, health care workers in close contact with patients who may be excreting polioviruses; unvaccinated parents of infantswho are to be given OPV; unvaccinated day-care-centre workers; residents of communities where routine immunization of infants and children has not been practised.

Adults at increased risk of exposure, who are unvaccinated, should receive a primary series of Inactivated Poliomyelitis Vaccine (Diploid Cell Origin) - IPV as outlined above; those with incomplete primary immunization should receive the remaining doses of the primary series, regardless of the interval since the last dose; those who have previously completed a primary series of Inactivated Poliomyelitis Vaccine should receive a single booster dose of 0.5 mL.

Adults who have not been adequately immunized against poliomyelitis are at a very small risk of developing vaccine-associated paralysis when children in the household are given live, oral poliovirus vaccine. Therefore, prior to use of the live, oral poliovirus vaccine for immunization of a family member, some health care personnel recommend that adults who have never received any polio vaccine should be given at least 2 doses of Inactivated Poliomyelitis Vaccine a month apart, or preferably,the full primary series.

The vaccine should be administered by s.c. injection. The injection may conveniently be made into the s.c. tissue near the insertion of the deltoid muscle. The site of injection should be prepared with a suitable antiseptic.

A separate sterile syringe and needle should be used for each individual patient to prevent transmission of hepatitis viruses and other infectious agents.

In order to avoid i.v. injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.

Withdrawing the Vaccine from a Sealed Glass Ampul: Tap the ampul to ensure that the solution is in the lower portion rather than in the neck of the ampul.

Wipe the neck of the ampul with a suitable antiseptic. Using a sterile piece of cotton or a sterile towel, break off the top of the ampul at the colored line (no file is required). Then with the sterile syringe and needle withdraw the contents of the ampul into the syringe, holding the ampul in such a way that the point of the needle is kept immersed throughout the withdrawal.

Once the ampul has been opened, any of its contents not used immediately should be discarded.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the health care provider also maintain a permanent record of the immunization history of each individual. This office record should contain the name of the vaccine, date given, manufacturer and lot number.

Supplied: Each perfectly clear and colorless vaccine contains: a suspension of 3 types of poliovirus, Type 1 (Mahoney), Type 2 (M.E.F.1) and Type 3 (Saukett), grown in human diploid strain MRC-5 cell cultures, concentrated, purified and inactivated with formaldehyde. Formaldehyde 27 ppm and 0.5% 2-phenoxyethanol are added as a preservative. Albumin (Human) is added as a stabilizer to a concentration of 0.5%. By calculation, the vaccine contains 20 ppm Tween 80 and less than 1 part per million of bovine serum.Trace amounts of streptomycin and/or polymyxin B and neomycin may be present from the cell culture growth medium. Ampuls of 0.5 mL. Packages of 5. Store between 2 and 8°C. Do not freeze.