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Hepatitis A vaccines summarised
(for use in India only)

A quick reference guide to hepatitis A vaccines

Havrix Junior (inactivated)1,2 facts
Published long-term protection data Up to 50 years (expected)*3
Seroconversion after one dose 100%** within 14 days†4 [LOCs to update number of days in seroconversion claim when appropriate, to align with local SmPC]
Studied in outbreak control The efficacy of Havrix was evaluated in different settings experiencing hepatitis A outbreaks (Alaska, Slovakia, USA, UK, Israel and Italy)1,2,5–8
Vaccine coverage at 80% resulted in controlling the outbreak within 4–8 weeks1,2
In outbreak scenarios, seroconversion rates of 96.8% were reported using Havrix Junior7
Safety evidence Global data across settings available. Generally well tolerated2,9
Internationally published evidence World’s most widely studied paediatric vaccine with over 150 clinical studies conducted in more than 30k subjects9
Global presence Registered in >85 countries with ~400 million doses distributed††10
WHO prequalified Yes11
Presentation PFS1
Coadministration Studied with routinely administered vaccines, such as typhoid fever, yellow fever, tetanus, measles, mumps, rubella, varicella1,2
Thermostability In case of temporary temperature excursion up to 25 °C: 3 days1

A quick reference guide to hepatitis A vaccines

Paediatric inactivated hepatitis A vaccine (Sanofi Pasteur)13,14 facts
Published long-term protection data 10 years of follow-up study13
Seroconversion after one dose 99.4%** after 14 days4 [LOCs to update number of days in seroconversion claim when appropriate, to align with local SmPC]
Studied in outbreak control No data available14
Safety evidence Generally well tolerated13–15
Internationally published evidence Limited global studies13,15,16
Global presence Licensed in >90 countries16
WHO prequalified No11
Presentation PFS14
Coadministration Studied with measles, mumps and rubella14
Thermostability 2–8 °C14

A quick reference guide to hepatitis A vaccines

Live attenuated vaccine17 facts
Published long-term protection data 17 years of follow-up study18
Seroconversion after one dose Up to 95%‡ after 6 weeks19
Studied in outbreak control The efficacy of an inactivated vaccine has been studied in China, with a protective efficacy of 95%20
Safety evidence Limited information available. Studies from 2 countries show no serious AEs17,20
Internationally published evidence Limited international data available20
Global presence Available in India21
WHO prequalified No11
Presentation Vial17
Coadministration No information available17
Thermostability 2–8 °C17
Find out more about hepatitis A and Havrix Junior

Universal vaccination

Review the evidence for UV

Preventing hepatitis A

Key steps in hepatitis A prevention

The burden of hepatitis A

Find out more about the hepatitis A burden

AE, adverse event; PFS, pre-filled syringe; UV, universal vaccination; WHO, World Health Organization

Havrix Junior can be administered to children and adolescents aged 1–15 years.1 Havrix can be administered to adults 16 years and over.12 Both are administered in a primary dose with a booster dose recommended 6–12 months after primary immunisation. The vaccines provide active immunisation against infections caused by hepatitis A in both age groups1,12

*A descriptive analysis was used to predict long-term seropositivity results for children based on studies of vaccines containing inactivated hepatitis A antigen either as standalone hepatitis A vaccine or combination hepatitis A and B vaccine. In order to extrapolate outcomes in children using data in adults, studies with data on adult vaccine doses of hepatitis A and B vaccine 720 EU or hepatitis A vaccine 1,440 EU were selected3
**In a comparative trial in which 332 seronegative children from 1–15 years of age were randomised to receive two doses of hepatitis A vaccine 6 months apart4
†After primary vaccination with Havrix Junior, a booster dose is recommended1
††In both paediatric and adult patient populations10
‡n=48019

References

  1. Havrix Junior SmPC, January 2022.
  2. Havrix India PI, January 2021.
  3. Agrawal A et al. Infect Dis Ther 2020; 9:785–796.
  4. Abarca K et al. Int J Infect Dis 2008; 12:270–277.
  5. McMahon BJ et al. Arch Pediatr Adolesc Med 1996; 150:733–739.
  6. Irwin DJ et al. Commun Dis Public Health 1999; 2:184–187.
  7. Kaic B et al. Vaccine 2001; 19:3615–3619.
  8. Kohl I et al. Eur J Epidemiol 2006; 21:893–899.
  9. André F et al. Expert Rev Vaccines 2002; 1:9–23. 
  10. GSK data on file; 2023N531266_00.
  11. World Health Organization (WHO). Prequalified vaccines. Available at: https://extranet.who.int/pqweb/vaccines/prequalified-vaccines (Accessed April 2023).
  12. Havrix Monodose SmPC, January 2022.
  13. Bravo C et al. Expert Rev Vaccines 2019; 18:209–223.
  14. Avaxim Pediatric SmPC, June 2020.
  15. Hong SS et al. Medicine 2019; 98:e14364.
  16. Kim H et al. Infect Dis Ther 2019; 8:105–112.
  17. Biovac-A India PI, March 2019.
  18. Chen Y et al. Vaccine 2018; 36:114–121.
  19. Faridi MM et al. Indian Pediatrics 2009; 46:29–34.
  20. Rao S et al. Hum Vaccin Immunother 2016; 12:3160–3165.
  21. UpToDate. Hepatitis A virus infection: treatment and prevention. Available at: https://www.uptodate.com/contents/hepatitis-a-virus-infection-treatment-and-prevention (Accessed April 2023).

For more information, please refer to the prescribing information or contact GlaxoSmithKline
via gcc.medinfo@gsk.com
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 Gulf.ProductQualityComplaints@gsk.com

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PM-RCH-HAV-WCNT-230002 | Date of preparation: Noember 2023