| Infanrix HEXA |
| Image may differ from actual product |
| The Business: | |
| Manufacturer: | GlaxoSmithKline |
| GlaxoSmithKline's total sales 2018: | £30.8 billion. Reference: GSK Key Facts |
| GlaxoSmithKline's vaccine sales 2018: | £5.9 billion. Reference: 2018 Annual Report |
| Infanrix HEXA's global sales in 2018: | £680 million. (Includes Infanrix and Pediarix). Reference: 2018 Annual Report p 228 |
| British Columbia Center for Disease Control expense, F/Y 2018/19 for Infanrix HEXA | $4,040,700 Reference: BCCDC FOIA request by TMOV, 12-06-19 |
| The Product: | |
| Description of Vaccine: | Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), |
| inactivated poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine | |
| Type of vaccine: | DTaP-HB-IPV-Hib. Given by Intramuscular injection |
| Primary medical reference: | Package insert for Canada |
| Ingredient (follow link to independent info) | Quantity | Units | Reference |
| aluminum (as aluminum salts) | .82 | mg | Package Insert |
| CDC Vaccine Type | DIPHTHERIA AND TETANUS TOXOIDS ACELLULAR PERTUSSIS POLIOVIRUS INACTIVATED HAEMOPHILUS INFLUENZA B AND HEPATITIS B VACCINE (HEXAVAX) |
| Serious adverse events, USA, during 2018 (Definition of serious: Note 1, Source: Note 2) | 354 |
| Number of injury awards paid by VICP (USA) for this vaccine type from 1988 until September 1, 2019 (Note 3) | N/A |
| Serious adverse events following immunization, Canada, during 2018, for the group [DTaP, DTaP-IPV, DTaP-IPV-Hib, DTaP-HB-IPV-Hib, DTaP-Hib, DTaP-HB-IPV] which includes this type of vaccine. (Note 4) | 89 |
| Age of patient | Intensity | Adverse reaction | Frequency | Reference |
| infants | any | local pain | 42.54% | Monograph, p 10 |
| infants | severe | local pain | 01.49% | Monograph, p 10 |
| infants | any | local redness | 48.51% | Monograph, p 10 |
| infants | >20 mm | local redness | 02.24% | Monograph, p 10 |
| infants | any | local swelling | 35.82% | Monograph, p 10 |
| infants | > 20 mm | local swelling | 03.73% | Monograph, p 10 |
| infants | >= 38°C | temperature | 55.97% | Monograph, p 10 |
| infants | > 39.5°C | temperature | 00.75% | Monograph, p 10 |
| infants | any | diarrhea | 35.82% | Monograph, p 10 |
| infants | Grade 3 = severe | diarrhea | 00.75% | Monograph, p 10 |
| infants | any | eating/drinking less than usual | 49.25% | Monograph, p 10 |
| infants | Grade 3 = severe | eating/drinking less than usual | 02.24% | Monograph, p 10 |
| infants | any | irritability/fussiness | 82.84% | Monograph, p 10 |
| infants | Grade 3 = severe | irritability/fussiness | 06.72% | Monograph, p 10 |
| infants | any | sleeping less than usual | 50.75% | Monograph, p 10 |
| infants | Grade 3 = severe | sleeping less than usual | 02.24% | Monograph, p 10 |
| infants | any | sleeping more than usual | 62.69% | Monograph, p 10 |
| infants | Grade 3 = severe | sleeping more than usual | 03.73% | Monograph, p 10 |
| infants | any | unusual crying for more than one hour | 42.54% | Monograph, p 10 |
| infants | Grade 3 = severe | unusual crying for more than one hour | 03.73% | Monograph, p 10 |
| infants | any | vomiting | 25.37% | Monograph, p 10 |
| infants | Grade 3 = severe | vomiting | 00.75% | Monograph, p 10 |
| n/a | n/a | appetite lost | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | irritability | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | crying abnormal | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | restlessness | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | pain | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | redness | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | local swelling at the injection site (<= 50 mm) | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | fever >= 38°C | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | fatigue | Very common: >= 10% | Monograph, p 10 |
| n/a | n/a | nervousness | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | vomiting | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | diarrhea | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | diarrhea | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | local swelling at the injection site (> 50 mm) | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | fever >39.5°C | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | pruritis | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | injection site reactions, including induration | Common: >= 1% and < 10% | Monograph, p 11 |
| n/a | n/a | lymphadenopathy | n/a | Monograph, p 11 |
| n/a | n/a | thrombocytopenia | n/a | Monograph, p 11 |
| n/a | n/a | Allergic reactions (including anaphylactic and anaphylactoid reactions) | n/a | Monograph, p 12 |
| n/a | n/a | Collapse or shock-like state (hypotonic hyporesponsive episode) | n/a | Monograph, p 12 |
| n/a | n/a | Apnea | n/a | Monograph, p 12 |
| n/a | n/a | Angioneurotic oedema | n/a | Monograph, p 12 |
| n/a | n/a | Extensive swelling reactions | n/a | Monograph, p 12 |
| n/a | n/a | Swelling of the entire injected limb | n/a | Monograph, p 12 |
| n/a | n/a | Vesicles at the injection site | n/a | Monograph, p 12 |
| infants and children < 2 years old | n/a | paralysis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | Guillain-Barré syndrome | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | neuropathy | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | encephalopathy | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | encephalitis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | meningitis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | neuritis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | allergic reactions mimicking serum sickness | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | hypotension | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | vasculitis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | lichen planus | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | erythema multiforme | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | arthritis | extremely rare | Monograph, p 12 |
| infants and children < 2 years old | n/a | muscular weakness | extremely rare | Monograph, p 12 |
| Ingredient | Quantity | Units | Notes |
| adsorbed purified capsular polysaccharide of Haemophilus influenzae type b (Hib) (PRP) covalently bound to approximately 25 mcg of tetanus toxoid |
10 | mcg | |
| diphtheria toxoid | 25 | Lf | |
| disodium phosphate | residue | ||
| filamentous haemagglutinin | 25 | mcg | |
| formaldehyde | residue | ||
| glutaraldehyde | residue | ||
| glycine | residue | ||
| HBsAg | 10 | mcg | |
| lactose | 12.6 | mg | |
| medium 199 | 1.15 | mg | |
| monopotassium phosphate | residue | ||
| neomycin sulphate | residue | ||
| pertactin | 8 | mcg | |
| pertussis toxoid | 25 | mcg | |
| polymyxin B sulphate | residue | ||
| polysorbate 20 | residue | ||
| polysorbate 80 | residue | ||
| potassium chloride | residue | ||
| sodium chloride | 4.5 | mg | |
| tetanus toxoid | 10 | Lf | |
| type 1 poliovirus | 40 | D-antigen Units (DU) | |
| type 2 poliovirus | 8 | DU | |
| type 3 poliovirus | 32 | DU | |
| water |
Notes:
Note 1- USA - Definition of serious adverse events: According to the CDC's Vaccine Adverse Events Reporting System (VAERS), events are classified as serious when any of the following outcomes are associated with the event: Death, Permanent Disability, Life Threatening, Hospitalized, Existing Hospitalization Prolonged, Congenital Anomaly or Birth Defect.
Note 2- United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - last month, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Sep 28, 2019 1:51:20 AM. A most user-friendly interface for you to access the VAERS database is here. It is presented by the National Vaccine Information Center and is called MedAlerts.
Note 3- VICP is the National Vaccine Injury Compensation Program, Monthly Statistics Report
Note 4- Canada - Definition of serious Adverse Events Following Immunization are those which are life-threatening, result in hospitalization or a prolongation of hospitalization, result in persistent or significant disability, or where the outcome is a birth defect or death, as defined by the World Health Organization. Source: Adverse Events Following Immunization (AEFI) Bi-annual Report from July 1 to December 31, 2018. and Adverse Events Following Immunization (AEFI) Bi-annual Report from January 1 to June 30, 2018.