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Safety
See how Infanrix hexa compares with a competitor in terms of local and systemic reactions post vaccination
Efficacy and experience
Infanrix hexa has been shown to be highly effective against pertussis and Hib,1 and this is supported by extensive real-world evidence from a number of countries in which it is used2-5
The value of pertactin in acellular vaccines
Infanrix hexa contains 8 μg of the adhesive antigen pertactin (PRN) – more than any other hexavalent vaccine available.1,6,7 Anti-PRN antibodies have been found after natural infection and
post vaccination8 and while there is no established correlation of protection for pertussis, these anti-PRN antibodies have been linked to increased protection against the disease9
Anti-PRN antibody levels in children* who did or did not develop pertussis**9
GMC, geometric mean concentration; PRN, pertactin
The same results were first published in Cherry et al. 19989
The image has been independently created by GSK from the original data
*Sera collected from subjects after third and fourth doses of vaccine (DTaP or DTwP) during household exposure of pertussis9
**Bordetella pertussis infection cases defined as cough illnesses of ≥7 days duration9
Which diseases does Infanrix hexa help protect against?
Watch the video below to learn more about the six diseases targeted by 6-in-1 vaccination: diphtheria,
tetanus, pertussis, Haemophilus influenzae disease, hepatitis B and polio1
Pertussis disease control
Give parents confidence with real-world evidence of proven pertussis disease control with Infanrix hexa*10
Disease reduction with DTaP vaccination 2+1 schedule in Italy*2
Data up to 2012: reproduced with permission from Gonfiantini et al. 20142
Data from 2012–2015: independently created by GSK from Pezzotti et al. 201810 and Signorelli et al. 201811
*The 2+1 vaccination schedule was pioneered in Italy in the 1970s12
**Infanrix hexa has been used exclusively in Italy from 2006 until 2013 following withdrawal of Hexavac13,14
Disease reduction with DTaP vaccination 2+1 schedule in Sweden3
Adapted from Folkhälsomyndigheten (Sweden Institute for Communicable Disease Control). Pertussis surveillance in Sweden: nineteen-year report3
Proven protection against hospitalisation due to pertussis
An acellular pertussis vaccine with the same components as Infanrix hexa1 showed 100% effectiveness after a booster dose using a 3+1 schedule (N=17,856; 95% CI: 97.9–100), against pertussis hospitalisation in a population-based case-control study*15
Effectiveness of acellular vaccines for preventing pertussis per dose (3+1 schedule in Switzerland)
The same data were first published in Mack et al. 202015
The graph has been independently created by GSK from the original data
Hib disease control
The confidence of Hib disease control, assessed in 10 European countries**,†4
Choose a country below to see the impact on Hib disease with Infanrix hexa
-
Ireland
Ireland
Infanrix hexa was introduced and used almost exclusively from 2008 to help protect against Hib disease4
Figure reproduced with permission from Wang et al. 20174
BCG, Bacillus Calmette-Guérin; Hib, Haemophilus influenzae type b; MenC, meningococcal serogroup C conjugate vaccine; PCV, pneumococcal conjugate vaccine
*Year of market entry4
**Catch-up campaign in 2005 and booster dose introduced in 20064
†Coadministered with booster dose at 13–15 months4 -
Netherlands
Netherlands
Infanrix hexa was used almost exclusively from 2011 to help protect against Hib disease4
Figure reproduced with permission from Wang et al. 20174
Hib, Haemophilus influenzae type b; PCV, pneumococcal conjugate vaccine
*Year of market entry4 -
Luxembourg, Slovakia, Belgium
Luxembourg
0 Hib cases between 1999–2014**
Slovakia
Decrease in invasive H. influenzae cases from 19 in 1999 to 0–5 in 2008–2012†
Belgium
Majority of H. influenzae cases reported in individuals >65 year old; no information on serotype distribution available††,‡
The same information was first published in Wang et al. 20174
The illustration has been independently created by GSK from the original data
Hib, Haemophilus influenzae type b; PCV, pneumococcal conjugate vaccine; RV, rotavirus vaccine
The available Hib surveillance data are influenced by country specific health policies and disease surveillance systems, diagnostic and case detection methods, and reporting processes. These factors, as well as possible changes in the casedefinition of invasive H. influenzae disease and laboratory testing methods over the years between 1999 and 2014, can all influence the accuracy and completeness of reporting, particularly when the number of cases is very low. Because of these variations, comparisons of Hib disease incidence between countries and trends over time should be interpreted with caution4
*Year of market entry4
**Hib vaccine coverage estimated to be 98–99% since 20024
†Hib vaccine coverage estimated to be 97–99% since 20034
††Surveilance data are not routinely collected in Belgium4
‡Hib vaccine coverage estimated to be 92–98% since 20044 -
Italy
Italy
Infanrix hexa was used almost exclusively from 2005 to help protect against Hib disease4
The graph is reproduced with the permission of Taylor & Francis. It was first published in Wang et al. 20174
From 2007, Hib surveillance data collected through the National Surveillance of Invasive Bacterial Disease were reported to the ECDC surveillance system
ECDC, European Centre for Disease Prevention and Control; Hib, Haemophilus influenzae type b; PCV, pneumococcal conjugate vaccine
*Year of market entry4
**Voluntary vaccination since 1995 and included in national vaccination programme in 19994 -
Sweden
Sweden
Infanrix hexa was introduced in 2003 and used almost exclusively from 2007 to help protect against Hib disease4
The graph is reproduced with the permission of Taylor & Francis. It was first published in Wang et al. 20174
Hib, Haemophilus influenzae type b; PCV, pneumococcal conjugate vaccine
*Year of market entry4 -
Germany
Germany
Infanrix hexa was introduced in 2000 and used almost exclusively from 2006 to help protect against Hib disease4
The graph is reproduced with the permission of Taylor & Francis. It was first published in Wang et al. 20174
Hib, Haemophilus influenzae type b; MMRV, measles, mumps, rubella and varicella; PCV, pneumococcal conjugate vaccine; RV, rotavirus vaccine
*Year of market entry4
**MMRV coadministered with booster dose (11–14 months)4 -
Czech Republic
Czech Republic
Infanrix hexa was introduced and used almost exclusively from 2007–2014 to help protect against Hib disease4
The graph is reproduced with the permission of Taylor & Francis. It was first published in Wang et al. 20174
BCG, Bacillus Calmette-Guérin; Hib, Haemophilus influenzae type b; MenB, meningococcal serogroup B protein vaccine; PCV, pneumococcal conjugate vaccine; RV, rotavirus vaccine
*Year of market entry4 -
Austria
Austria
Infanrix hexa was introduced in 2004 and used almost exclusively from 2006 to help protect against Hib disease4
The graph is reproduced with the permission of Taylor & Francis. It was first published in Wang et al. 20174
Hib, Haemophilus influenzae type b; PCV, pneumococcal conjugate vaccine; RV, rotavirus vaccine
*Year of market entry4
**A schedule of 3 priming doses and a booster at 12–24 months was used from 2004–20104
Quick links
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aP, acellular pertussis; BCG, Bacillus Calmette–Guérin; CI, confidence interval; DTaP, acellular diphtheria-tetanuspertussis;
DTwP, whole-cell diphtheria-tetanus-pertussis; ECDC, European Centre for Disease Prevention and Control;
GMC, geometric mean concentration; Hib, Haemophilus influenzae type b; MenB, meningococcal serogroup B protein vaccine; MenC, meningococcal serogroup C conjugate vaccine; MMRV, measles, mumps, rubella and varicella; PCV, pneumococcal conjugate vaccine; PRN, pertactin; PT, pertussis toxin; RV, rotavirus vaccine; SP-MSD Pa2c, Pentavac®
Sanofi Pasteur MSD; VE, vaccine effectiveness
*This study used an acellular pertussis vaccine by GSK containing the same pertussis components as Infanrix hexa1,15
**Infanrix hexa was used almost exclusively from the year specified for each country until 20144
†Surveillance data were not routinely collected in Belgium4
Infanrix hexa safety information1
Contraindications:
Hypersensitivity to the active ingredients or to any of the excipients or residues. Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines, or if the child has experienced and encephalopathy of unknown aetiology, occurring within 7 days following vaccination with pertussis containing vaccine.
Warnings and precautions:
Administration should be postponed in subjects suffering from acute severe febrile illness. A protective immune response may not be elicited in all vaccines. Use with caution if any of the following has occurred in temporal relation to receipt of pertussis-containing vaccine within 48 hours:
- Temperature of > 40.0°C.
- Collapse or shock-like state.
- Persistent, inconsolable crying lasting > 3 hours.
- Convulsions with or without fever, occurring within 3 days of vaccination.
Pregnancy and lactation:
Infanrix hexa is not intended to be used in adults.
Adverse events:
Very Common – Appetite lost, pain, redness, local swelling at injection site (< 50 mm), fever > 38°C, fatigue.
References
- Infanrix hexa local prescribing information.
- Gonfiantini MV et al. Euro Surveill 2014; 19:pii=20921.
- Folkhälsomyndigheten (Swedish Institute for Communicable Disease Control). Pertussis surveillance in Sweden: nineteen-year report. Available at: https://www.folkhalsomyndigheten.se/contentassets/65ed8f6dbdab4999bc358fcd9b657e77/pertussis-sweden-nineteen-year-report.pdf (Accessed April 2022).
- Wang S et al. Expert Rev Vaccines 2017; 16:1095–1105.
- Schmitt HJ et al. JAMA 1996; 275:37–41.
- Hexyon SmPC, 2020.
- Vaxelis SmPC, 2022.
- Edwards KM, Decker MD. Chapter 44: Pertussis vaccines. In: Plotkin S et al. (eds). Plotkin’s vaccines. 7th Edition. 2018. Elsevier, Philadelphia.
- Cherry JD et al. Vaccine 1998; 16:1901–1906.
- Pezzotti P et al. Vaccine 2018; 36:1435–1443.
- Signorelli C et al. Ann Ig 2018; 30:1–10.
- Baldo V et al. Hum Vaccin Immunother 2014; 10:2805–2813.
- Orsi A et al. J Prev Med Hyg 2018; 59:E107–E119.
- European Medicines Agency (EMA). News and press release archive: European Medicines Agency recommends suspension of Hexavac. 2005. Available at: https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-hexavac (Accessed April 2022).
- Mack L et al. Vaccine 2020; 38:1444–1449.
For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via Gulf-KSA.Product-Complaints@gsk.com
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PM-RCH-INH-WCNT-230001 | Date of preparation: February 2023
