Safety
See how Infanrix hexa compares with a competitor in terms of local and systemic reactions post vaccination
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Infanrix hexa is relied upon globally with 20 years of clinical use and 60 million babies vaccinated*1,2
Among all available hexavalent vaccines, it has the longest follow-up of immune persistence – from infancy all the way through to adolescence1,3–6
Infanrix hexa is the only hexavalent DTaP 2+1 vaccination schedule with seven-year follow-up of antibody persistence against all antigens, including pertussis1,3–5
Years of documented overall immune persistence follow-up**,†
Infanrix hexa has over 14 years** of documented follow-up in HB1,6
Long-term antibody persistence against hepatitis B was observed in adolescents previously vaccinated with Infanrix hexa 3+1 schedule, with over half of participants still showing levels of anti-HBs above the threshold of protection after 14 years6
Infanrix hexa contains the same HB antigen, at the same dose, as Engerix-B,‡‡1,7 which has 20 years of immune persistence follow-up4,8
anti-HBc, hepatitis core antibody; anti-HBs, hepatitis B surface antibody; CI, confidence interval; DTaP, acellular diphtheria-tetanuspertussis;
GMC, geometric mean concentration; HB, hepatitis B; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus
*210 million doses/3.5 = 60 million babies vaccinated (divided by 3.5 as the median of the 3+1 and 2+1 schedules)2
**Data not from head-to-head comparison studies
†Data for all antigens together, follow-up data for hepatitis B alone may be longer for some vaccines
††3+1 schedule3
‡‡Monovalent hepatitis B vaccine with the same HBV antigen component as Infanrix hexa1,7
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:
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
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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©2023 GSK group of companies or its licensor. All rights reserved.
PM-RCH-INH-WCNT-230001 | Date of preparation: February 2023