You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

Helping you support parents through the

first vaccination experience

A baby’s first vaccination may raise questions and can be a source of concern for parents. On this page, find out why communication from their healthcare professional about vaccination is so important for new parents and discover the tools you need in our expert communication tutorials

Communication from healthcare professionals
plays a critical role in the decision to vaccinate1

The decision to vaccinate is strongly influenced by the mother’s attitude to vaccination1
A 2018 survey of mothers in France (N=3,000) found:1

icon

Mothers increasingly use the internet to find information about vaccination

icon

Despite this, trust in HCPs remains high – 8 out of 10 turned to their HCP for information about vaccination

icon

Vaccination coverage was higher among mothers who recalled receiving advice from their HCP about vaccination

Reassure parents with Infanrix hexa2

Lower odds of adverse reactions vs. DT2aP-HBV-IPV-Hib2

A meta-analysis of six head-to-head studies showed that 9 out of 11 adverse reactions, as well as any discontinuation,* analysed were significantly less frequent with Infanrix hexa vs. DT2aP-HBV-IPV-Hib2

  • Read more

    Head-to-head analysis of reactogenicity2

    The meta-analysis included studies which compared adverse events following primary series vaccination with Infanrix hexa or DT2aP-HBV-IPV-Hib.2
    The analysis extracted data to estimate the incidence of 11 local and systemic adverse reactions, as well as any discontinuation, after primary vaccination with Infanrix hexa compared with DT2aP-HBV-IPV-Hib2
    Adverse reactions included:2

    • Pain, redness and swelling at the injection site, any grade 3 event (local adverse reactions)
    • Fever, drowsiness, irritability, persistent crying, anorexia, vomiting, any grade 3 event (systemic adverse reactions)

Find out more about the reactogenicity profile of Infanrix hexa

VIEW SAFETY PROFILE

Confidence of long-term follow-up data

The safety profile of Infanrix hexa is supported by 17 years of post-marketing surveillance.3

Infanrix hexa helps protect against six vaccine-preventable diseases and provides the reassurance of long-term immune persistence follow-up4,5

Infanrix hexa is supported by a 10-year follow-up of immune persistence against hepatitis B for the 2+1 schedule6

This includes up to 15 years of follow-up for hepatitis B and 7 years for all other antigens5,7

  • Read more

    In this study, 312 children were randomly assigned to receive Infanrix hexa or separate Infanrix (DTaPIPV/Hib) and Engerix-B (HBV) vaccinations at 3, 5 and 11–12 months of age.* At age 10–11 years, 95 and 90 patients, respectively were followed up to assess the percentage of subjects who achieved anti-HBs concentrations ≥100 mIU/mL after a challenge dose of Engerix-B6

    The results showed that 48.4% (95% CI: 38.0–58.9) in the Infanrix hexa group and 58.4% (95% CI: 47.5–68.8) in the Infanrix+HBV group had seroprotective concentrations (≥10 mIU/mL) of anti-HBs prior to the challenge dose. After the challenge dose, 93.6% (95% CI: 86.6–97.6) and 94.4% (95% CI: 87.4–98.2), respectively, had an anti-HBs concentration ≥100 mIU/mL6

    Zinke et al. 20105

    This study assessed the persistence of the immune response to Infanrix hexa in children aged 4–6 and 7–9 years of age previously vaccinated with 4 doses of Infanrix hexa (N=403). After the 4th dose, in subjects who had not received additional booster doses, seroprotective antibody levels persisted up
    to 9 years of age in ≥90% of subjects for diphtheria, Hib and poliomyelitis, in 77.2% subjects for hepatitis B and in 64.7% of subjects for tetanus

    Schwartz et al. 20197
    This open-label, non-randomised study evaluated antibody persistence against HBV in adolescents aged 14–15 years previously vaccinated with Infanrix hexa (N=302) administered as a 3+1 schedule in their first 2 years of life as part of the national newborn immunisation program in Germany. Participants
    received one challenge dose of monovalent HBV vaccine. Pre challenge dose, 53.7% (95% CI: 47.6–59.8) of participants had anti-HBs concentrations ≥10 mIU/mL (seroprotection cut-off) and 16.8% (95% CI: 12.5–21.8) had anti-HBs concentrations ≥100 mIU/mL. One month post challenge dose, 93.3% (95% CI: 89.6–96.0) of adolescents had anti-HBs concentrations ≥10 mIU/mL and 87.3% (95% CI: 82.7–91.1) had anti-HBs concentrations ≥100 mIU/mL

Find out more about immune persistence

EXPLORE THE DATA

Quick links

anti-HBs, hepatitis B surface antibody; DTaP, acellular diphtheria-tetanus-pertussis; DT2aP, diphtheria, tetanus and acellular pertussis; FHA, filamentous haemagglutinin; HB, hepatitis B; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; Hib, Haemophilus influenzae type b; IPV, inactivated polio virus; PCV7, 7-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PRP, polyribosylribitol-phosphate; PT, pertussis toxin

*Local adverse reactions: pain, redness, swelling; systemic adverse reactions: fever, drowsiness, irritability, persistent crying, anorexia, any grade 3; and discontinuations due to any reason2

Infanrix hexa safety information4

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

  1. Martinot A et al. Infect Dis Now 2021; 51:153–158.
  2. Mukherjee P et al. Exp Rev Vaccines 2021; 20:319–330.
  3. Puente Gómez I et al. Expert Rev Vaccines 2020; 19:771–779.
  4. Infanrix hexa local prescribing information.
  5. Zinke M et al. Hum Vaccin 2010; 6:189–193.
  6. Avdicova M et al. Vaccine 2015; 33:2727–2733.
  7. Schwartz TF et al. Hum Vaccin Immunother 2019; 15:235–241.

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

Trademarks are property of their respective owners.
©2023 GSK group of companies or its licensor. All rights reserved.

PM-RCH-INH-WCNT-230001 | Date of preparation: February 2023