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Engerix B

Engerix B 20 micrograms/1 ml

Manufacturer
GlaxoSmithKline UK
Label last updated
02 Jun 2026
Source
Official SmPC ↗

Hepatitis B vaccine in two strengths: 10 micrograms for babies, children and young people up to 15 years, and 20 micrograms for 16 and over. The current formulation contains no thiomersal.

53 findings, each with the section of the label it comes from.

Ingredients and materials

  • Hepatitis B surface antigen 10 micrograms in a 0.5 ml dose for people up to and including 15 years, including neonatess.2
  • Hepatitis B surface antigen 20 micrograms in a 1 ml dose for people aged 16 and overs.2
  • The antigen is adsorbed on aluminium hydroxide hydrated: 0.25 mg Al3+ in the 10 microgram dose and 0.50 mg Al3+ in the 20 microgram dose, present as an adjuvants.2
  • Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technologys.2
  • Excipients: sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate, water for injectionss.6.1
  • The current formulation does not contain thiomersal, an organomercury compound used as a preservative in the older formulation; adverse effects reported with the older formulation are still listeds.4.8
  • Declared essentially sodium free, less than 1 mmol (23 mg) per doses.4.4

Manufacture, storage and handling

  • Shelf life 3 yearss.6.3
  • Store at 2C to 8C, do not freeze, store in the original packages.6.4
  • Stability data indicate the vaccine is stable at temperatures up to 37C for 3 days or up to 25C for 7 days, but these data are intended to guide professionals in case of a temporary temperature excursion onlys.6.4
  • A fine white deposit with a clear colourless supernatant may be seen on storage; the vaccine is slightly opaque once shakens.6.6
  • The entire contents of a mono-dose container must be withdrawn and used immediatelys.6.6
  • Intramuscular injection into the deltoid in adults and children, or the anterolateral thigh in neonates, infants and young childrens.4.2
  • Must not be administered in the buttock or intradermally, since this may result in a lower immune response, and must under no circumstances be given intravascularlys.4.4
  • Exceptionally may be given subcutaneously in patients with thrombocytopenia or bleeding disorderss.4.2
  • Do not pull the syringe plunger out of the barrel; if it happens, do not administer the vaccines.6.6
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • Schedules depend on age and circumstances: 0, 1, 6 months gives optimal protection at month 7; the accelerated 0, 1, 2 month schedule needs a fourth dose at 12 months because antibody concentrations after the third dose are lower; dialysis patients get four double doses of 2 x 20 microgramss.4.2

Safety findings

  • The only listed contraindication is known hypersensitivity to the active substances, the excipients, or after signs of hypersensitivity to a previous Engerix B doses.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection is not a contraindications.4.3
  • Fainting can occur after or even before any vaccination, especially in adolescents, as a response to the needle; it can be accompanied by transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery, and procedures should be in place to avoid injury from faintss.4.4
  • Because of the long incubation period of hepatitis B, an unrecognised infection may already be present at the time of immunisation and the vaccine may not prevent it in that cases.4.4
  • The vaccine will not prevent infection from hepatitis A, C or Es.4.4
  • As with any vaccine, a protective immune response may not be elicited in all vaccineess.4.4
  • Factors observed to reduce the immune response include older age, male gender, obesity, smoking, route of administration and some chronic underlying diseases; serological testing should be considered for those at risk of not reaching seroprotection, and extra doses may be needed for non-responderss.4.4
  • In HIV infected patients, patients with renal insufficiency including those on haemodialysis, and people with an impaired immune system, adequate antibody concentrations may not be obtained after the primary course and additional doses may be requireds.4.4
  • The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very premature infants born at or before 28 weeks, particularly those with previous respiratory immaturity; vaccination should not be withheld or delayeds.4.4
  • The two-dose 0, 6 month schedule for 11 to 15 year olds may mean protection is not obtained until after the second dose, so it should only be used when there is a low risk of infection during the course and completion can be assureds.4.2
  • Co-administration with the HPV vaccine Cervarix showed lower anti-HBs geometric mean antibody concentrations, though seroprotection rates were unaffected: 97.9 per cent with concomitant vaccination against 100 per cent with Engerix B alone. The label states the clinical significance is not knowns.4.5
  • Similar administration to people on immunosuppressive treatment or with immunodeficiency may not produce an adequate immune responses.4.5
  • Pregnancy: the effect of the hepatitis B surface antigen on foetal development has not been assessed, though as with all inactivated viral vaccines harm to the foetus is not expected; the vaccine should be used during pregnancy only when clearly needed and the possible advantages outweigh the possible riskss.4.6
  • Breastfeeding: the effect on breastfed infants of giving the vaccine to their mothers has not been evaluated in clinical studies, as information on excretion into breast milk is not available. No contraindication has been establisheds.4.6
  • Fertility: Engerix B has not been evaluated in fertility studiess.4.6
  • The safety profile is based on 5,329 subjects followed in 23 studiess.4.8
  • Post-marketing reports at frequency not known include: meningitis, thrombocytopenia, anaphylaxis and allergic reactions including anaphylactoid reactions and reactions mimicking serum sickness, polyarteritis nodosa, encephalitis, encephalopathy, convulsions, paralysis, neuritis including Guillain-Barre syndrome, optic neuritis and multiple sclerosis, neuropathy, hypoaesthesia, vasculitis, hypotension, apnoea in very premature infants, erythema multiforme, angioneurotic oedema, lichen planus, arthritis and muscular weaknesss.4.8
  • Common reactions: appetite lost, drowsiness, headache in adults, gastrointestinal symptoms such as nausea, vomiting, diarrhoea and abdominal pain, fever of 37.5C or above, malaise, swelling and induration at the injection sites.4.8
  • Very common reactions: irritability, headache in children, pain and redness at the injection site, fatigues.4.8
  • Overdose has been reported in post-marketing surveillance and the events were similar to normal administrations.4.9

Evidence and claims

  • Anti-HBs antibody concentrations of 10 mIU/ml or more 'correlate with protection' against hepatitis B infection, a surrogate measure rather than observed cases of diseases.5.1
  • In field studies a protective efficacy between 95 and 100 per cent was demonstrated in neonates, children and adults at risks.5.1
  • In neonates of HBeAg positive mothers immunised without hepatitis B immunoglobulin at birth, 95 per cent protective efficacy was demonstrated one month after the last dose; simultaneous administration of immunoglobulin and vaccine at birth increased this to 98 per cents.5.1
  • In neonates born to carrier mothers who did not receive immunoglobulin at birth, a challenge dose was given twenty years after primary vaccination: seroprotection was 54.2 per cent before the challenge dose and 98.7 per cent after it, demonstrating immune memory rather than persisting antibody levelss.5.1
  • An anamnestic (memory) response was seen in 93.9 per cent of those whose antibody level had fallen below 10 mIU/ml and 100 per cent of those still above it, 97.2 per cent overalls.5.1
  • Seroprotection rates in healthy subjects up to 15 years: at month 7 with the 0, 1, 6 month schedule, 96 per cent or above; with the 0, 1, 2-12 month schedule, 15 per cent at month 1, 89 per cent at month 3 and 95.8 per cent at month 13s.5.1
  • Some of the seroprotection data were generated with thiomersal containing vaccines; two further studies with the current thiomersal free formulation in healthy infants and adults showed similar seroprotection ratess.5.1
  • Long-term follow-up in 11 to 15 year olds showed seroprotection falling over time: with the 10 microgram 0, 1, 6 month schedule it was 98.2 per cent at month 7 and 91.4 per cent at 66 months; with the 20 microgram 0, 6 month schedule it was 11.3 per cent at month 2 and 26.4 per cent at month 6, rising to 96.7 per cent at month 7s.5.1
  • Current data do not support the need for a booster in immunocompetent subjects who responded to a full primary course, but boosters should be given to immunocompromised subjects such as those with chronic renal failure, haemodialysis patients and HIV positive subjects, with testing every 6 to 12 monthss.4.2
  • Preclinical safety data satisfy the requirements of the WHOs.5.3

Document and licensing

  • Marketing authorisation holder: SmithKline Beecham Ltd, London, trading as GlaxoSmithKline UKs.7
  • First authorised 5 February 2001, latest renewal 25 February 2011s.9
  • Text last revised 20 May 2026s.10
  • The label explains that the reported adverse effects come from both the thiomersal containing and the current thiomersal free formulationss.4.8
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

1 dose (0.5 ml) contains : 
 Hepatitis B surface antigen^1,2, 10 micrograms 
 ^1Adsorbed on aluminium hydroxide, hydrated     Total: 0.25 milligrams Al^3+ ^2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
 1 dose (1 ml) contains :
 Hepatitis B surface antigen^1,2 , 20 micrograms 
 ^1Adsorbed on aluminium hydroxide, hydrated     Total: 0.50 milligrams Al^3+ ^2Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
 For the full list of excipients, see section 6.1

What these are, in plain English

  • aluminium - An aluminium salt. It is an adjuvant: it makes the immune system respond more strongly to the vaccine. Aluminium in vaccines has been used since the 1930s.
  • yeast - Used in the laboratory to produce proteins. Traces can remain, which is why a yeast allergy can be a problem.
  • recombinant - Made by genetic engineering: the gene for one piece of the germ is put into a laboratory cell or bacterium, which then makes that piece.

Other ingredients (excipients)

Section 6.1 source ↗

  • Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
  • Disodium phosphate dihydrate
  • Sodium dihydrogen phosphate
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
  • For adsorbent, see section 2.
Audit trail: every flagged sentence in the document (44)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. Patients with renal insufficiency, including patients undergoing haemodialysis, have a reduced immune response to hepatitis B vaccines.

    Section 4.2 Posology and method of administration source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. Based on adult experience, vaccination with a higher dosage of antigen may improve the immune response.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • antigen - The part of a germ that the immune system recognises and remembers.

    Efficacy, effectiveness and endpoints matched: immune response

  3. Either the 0, 1, 2 and 12 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response.

    Section 4.2 Posology and method of administration source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  4. When available, hepatitis B immune globulins (HBIg) should be given simultaneously with Engerix B at a separate injection site as this may increase the protective efficacy.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  5. However, in immunocompromised subjects (eg subjects with chronic renal failure, haemodialysis patients, HIV positive subjects), boosters should be administered to maintain anti-HBs antibody concentrations equal or higher than the accepted protective level of 10 m IU/ml.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  6. For these immunocompromised subjects, post-vaccination testing every 6-12 months is advised.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

4.4 Special warnings and precautions for use

  1. ENGERIX B Junior should not be administered in the buttock or intradermally since this may result in a lower immune response.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  3. A number of factors have been observed to reduce the immune response to hepatitis B vaccines.

    Section 4.4 Special warnings and precautions for use source ↗

    Efficacy, effectiveness and endpoints matched: immune response

4.5 Interaction with other medicinal products and other forms of interaction

  1. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.
    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    Efficacy, effectiveness and endpointsNo data / not studied matched: geometric mean, not known

  2. Engerix B may be used to complete a primary immunisation course started either with plasma-derived or with other genetically-engineered hepatitis B vaccines, or, if it is desired to administer a booster dose, it may be administered to subjects who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Animal, human or cell-line derived material matched: plasma

  3. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited (see section 4.4).

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • immunosuppressive - A medicine or treatment that dampens the immune system.

    Efficacy, effectiveness and endpoints matched: immune response

4.6 Fertility, pregnancy and lactation

  1. The effect of the HBsAg on foetal development has not been assessed.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Animal, human or cell-line derived materialNo data / not studied matched: foetal, not been assessed

  2. The effect on breastfed infants of the administration of Engerix B to their mothers has not been evaluated in clinical studies, as information concerning the excretion into the breast milk is not available.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.

    No data / not studied matched: has not been evaluated

  3. Engerix B has not been evaluated in fertility studies.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.

    No data / not studied matched: has not been evaluated

4.8 Undesirable effects

  1. The current formulation of Engerix B does not contain thiomersal (an organomercuric compound).

    Section 4.8 Undesirable effects source ↗

    Trace residues and process chemicals matched: thiomersal

  2. The following undesirable effects have been reported following the use of the thiomersal containing formulations as well as the thiomersal free formulation.

    Section 4.8 Undesirable effects source ↗

    Trace residues and process chemicals matched: thiomersal

  3. In one clinical study conducted in adults with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, fatigue, gastro-enteritis, headache and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations.

    Section 4.8 Undesirable effects source ↗

    Trace residues and process chemicals matched: thiomersal

  4. In one clinical study conducted in children with the current formulation (thiomersal free formulation), the incidence of pain, redness, swelling, drowsiness, irritability, loss of appetite and fever was comparable to the incidence observed in the clinical studies conducted with former thiomersal containing vaccine formulations.

    Section 4.8 Undesirable effects source ↗

    Trace residues and process chemicals matched: thiomersal

  5. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  6. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  7. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  8. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  9. Encephalitis, encephalopathy, convulsions, paralysis, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), neuropathy, hypoaesthesia

    Section 4.8 Undesirable effects source ↗

    In plain English

    • encephalitis - Inflammation of the brain.

    Rare or very rare serious events matched: guillain

  10. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  11. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  12. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

  13. Not known (cannot be estimated from the available data)

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

5.1 Pharmacodynamic properties

  1. In field studies, a protective efficacy between 95% and 100% was demonstrated in neonates, children and adults at risk.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  2. In healthy subjects in high risk area, one month after the last vaccine dose, a 95% protective efficacy (serum anti HBs IgG ≥ 10 mIU/ml) was demonstrated in neonates of HBeAg positive mothers, immunised according to the 0, 1, 2 and 12 month or 0, 1 and 6 month schedules without concomitant administration of hepatitis B immunoglobulin (HBIg) at birth.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  3. However, simultaneous administration of HBIg and vaccine at birth increased the protective efficacy to 98%.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  4. 95% CI = exact 95% confidence interval;

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • confidence interval - The range of results within which the true figure is likely to sit. A wide range means the result is less certain.

    Efficacy, effectiveness and endpoints matched: confidence interval

  5. The data in the above table were generated with thiomersal containing vaccines.

    Section 5.1 Pharmacodynamic properties source ↗

    Trace residues and process chemicals matched: thiomersal

  6. Two additional clinical studies conducted with the current formulation of Engerix B, which does not contain thiomersal, among healthy infants and adults, elicit similar seroprotection rates as compared to former thiomersal containing formulations of Engerix B.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.

    Trace residues and process chemicals matched: thiomersal

  7. -Persistence of immune response in subjects from 11 years up to and including 15 years of age:

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  8. The long-term immune response was assessed in a clinical trial in subjects from 11 years up to and including 15 years of age at the time of primary vaccination.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  9. The seroprotection rates (i.e. percentages of subjects with anti-HBs antibody concentrations ≥ 10m IU/ml) with the two different dosages and schedules were evaluated up to 66 months after the first dose of the primary vaccination and are presented in the table below (ATP cohort for efficacy):

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  10. Geometric Mean Concentrations (GMC) were 7238 mIU/ml and 2739 mIU/ml respectively.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.

    Efficacy, effectiveness and endpoints matched: geometric mean

  11. The data in the above table were generated with thiomersal containing vaccines.

    Section 5.1 Pharmacodynamic properties source ↗

    Trace residues and process chemicals matched: thiomersal

  12. Two additional clinical studies conducted with the current formulation of Engerix B, which contains no thiomersal, among healthy infants and adults, elicit similar seroprotection rates as compared to former thiomersal containing formulations of Engerix B.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • seroprotection - Having an antibody level above a set threshold, taken as a sign of protection.

    Trace residues and process chemicals matched: thiomersal

  13. - Persistence of immune response and rechallenge of subjects aged 15 to 16 years, 14 years after primary vaccination:

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  14. N = number of subjects with both pre- and post-vaccination results available n = number of responders % = percentage of responders 95% CI = exact 95% confidence interval;

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • confidence interval - The range of results within which the true figure is likely to sit. A wide range means the result is less certain.

    Efficacy, effectiveness and endpoints matched: confidence interval

6.6 Special precautions for disposal and other handling

  1. In the event of either being observed, do not administer the vaccine.

    Section 6.6 Special precautions for disposal and other handling source ↗

    In plain English

    • do not administer - The label instructs that it must not be given.

    Not recommended, contraindicated or restricted matched: do not administer

  2. If it happens, do not administer the vaccine.

    Section 6.6 Special precautions for disposal and other handling source ↗

    In plain English

    • do not administer - The label instructs that it must not be given.

    Not recommended, contraindicated or restricted matched: do not administer

Read the whole document at the source ↗