5-in-1 Vaccine

Vaccine

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This page is about the 5-in-1 vaccine that was used in the UK until 2017. It is not about the non-UK versions, sometimes called the pentavalent. Please see the global pentavalent vaccines section for more information about vaccines used in other regions of the world.

The 5-in-1 vaccine was used in the UK from 2004 but was replaced by the 6-in-1 vaccine for all babies born on or after 1st August 2017. Both vaccines give protection against diphtheria, tetanus, whooping cough (pertussis), polio and Hib disease (Haemophilus influenzae type b). The 6-in-1 vaccine also gives protection against hepatitis B, a cause of serious liver disease.

Before vaccines existed, these diseases used to kill thousands of children in the UK every year (see the table in 'More information about the vaccine' at the bottom of the page). 

The 5-in-1 vaccine was given at 2, 3 and 4 months in the UK. The 5-in-1 vaccines used in the UK did not contain any live bacteria or viruses and cannot cause any of the diseases they protect against.

Two brands of 5-in-1 vaccine were used in the UK: Pediacel and Infanrix IPV+Hib (see the Patient Information Leaflet).

 

The 5-in-1 was given to babies in the UK in three doses when they were 8, 12 and 16 weeks old. The repeated doses were needed to give a good immune response. This schedule was the same as the replacement 6-in-1 vaccine.

 

Almost all babies were able to receive the 5-in-1 vaccine. But there were some cases in which a baby could not have the vaccine:

  • if they had signs of a neurological problem that was getting worse, including poorly controlled epilepsy. The vaccine could be given after the condition was controlled.
  • if they were allergic to the vaccine or any of its ingredients (see section on 'Ingredients' for details)

 

Common (affecting up to 1 in 10 people at each dose):

  • redness, tenderness and/or swelling at the injection site
  • raised temperature (fever)
  • irritability
  • sickness
  • diarrhoea
  • loss of appetite

Many of these symptoms can be relieved by giving paracetamol (Calpol) if your child is over two months, or ibuprofen if your child is over three months and weighs more than 5kg (see NHS Choices for more advice on giving painkillers to babies and children).

Rare (affecting up to 1 in 1000 people at each dose):

  • high temperatures, sometimes leading to fits (also called convulsions or febrile seizures)
  • unusual high-pitched screaming and hypotonic-hyporesponsive episodes (HHE), during which the child may become blue, pale and/or limp.

You should consult your doctor if these happen after vaccination. This is mainly to check that it is the vaccine causing the symptoms, and not some unrelated disease. Symptoms such as fits can be very worrying for parents, but there is no evidence of long-term effects. Children can normally safely receive vaccines in the future. For more information on febrile seizures generally, see NHS Choices.

As with any vaccine, medicine or food, there is a very small chance of a severe allergic reaction (anaphylaxis). Anaphylaxis is different from less severe allergic reactions because it causes life-threatening breathing and/or circulation problems. It is always serious but can be treated with adrenaline.

In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations, but all of these people survived. Around 117 million doses of vaccines were given in the UK during this period, making the overall rate around 1 in 900,000. Depending on the cause of the reaction, and following expert guidance, the person may be able to have vaccinations in the future.

Reactions listed under ‘possible side effects’ or ‘adverse events’ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.

See more information on the monitoring of vaccine safety.

 

Apart from the active ingredients (the antigens), the 5-in-1 vaccines used in the UK contained very small amounts of these ingredients:

  • a small amount of aluminium, which strengthens and lengthens the immune response to the vaccine. See more information on aluminium in vaccines.
  • sodium chloride (salt)
  • polysorbate, used as an emulsifier (to hold other ingredients together)
  • lactose and Medium 199 (containing amino acids, mineral salts and vitamins), both used as stabilisers (Infanrix IPV+Hib only)
  • a very small amount of phenol, used as a preservative (Pediacel only).

Many of these ingredients are already found naturally in the body or food.

 

Global pentavalent vaccines are variations of the UK’s 5-in-1 vaccine, and recommended as part of routine childhood immunisations by the World Health Organization (WHO).

The vaccines give protection against five diseases - diphtheria, tetanus, pertussis, hepatitis B, and Hib disease (Haemophilus influenzae type b) (DTwP-HepBHib). This is slightly different from the UK’s 5-in-1, which did not include hepatitis B, but did include polio. Countries that use pentavalent vaccines immunise children against polio separately.

Pentavalent vaccines use the whole-cell pertussis vaccine (wP), rather than acellular pertussis vaccine (aP). Whole-cell pertussis vaccine is made using killed whole pertussis bacteria, and may lead to a greater risk of side effects, such as high fever and seizures (fits). Acellular pertussis vaccine is made using only parts of the pertussis bacteria, and has a lower risk of side effects.

From late 2023, lower income countries, which receive support from GAVI, the Vaccine Alliance, for their childhood immunisation programmes, will be able to shift from the current pentavalent vaccines to a 6-in-1 (hexavalent) vaccine that still uses the whole-cell pertussis vaccine but incorporates the inactivated polio vaccine (IPV).  According to the WHO, a benefit of the wP vaccine, despite its greater risk of side-effects, is that it is does not require as many doses, compared to the aP vaccine. It is therefore a more cost-effective option.

The recommended vaccine schedule for pentavalent vaccines are three doses, four weeks apart, starting from when a baby is six weeks old.

 

The full name of the 5-in-1 vaccine used in the UK was DTaP/IPV/Hib. This stands for ‘Diphtheria, Tetanus, acellular Pertussis, Inactivated Polio Vaccine, Hib (Haemophilus influenzae type b)’. The 5-in-1 protects against these five different diseases. 

The introduction of a vaccine against these five diseases resulted in a remarkable decline in the number of deaths. The table below shows the average number of deaths in the UK each year, before and after, introduction of the vaccine:

Disease Before After
Diphtheria 3500 0
Tetanus 140 0
Pertussis 1000 3
Polio 200 0
Hib Disease 60 0
TOTAL 4900 3

Source: Public Health England and the Health Protection Agency archive

The 5-in-1 includes the acellular pertussis (whooping cough) vaccine - the ‘aP’ in ‘DTaP’. This uses three or five proteins from pertussis bacteria, which help provide protection against whooping cough. Using these purified proteins reduces the chance of more severe side effects such as high temperatures, screaming episodes, and hypotonic-hyporesponsive episode (read about HHE in 'Safety and side effects' section above). By comparison, the whole cell (wP) vaccine contains thousands of components and has a greater chance of side effects.

The Hib part of the 5-in-1 is a conjugate vaccine. Sugars taken from the capsule around the Hib bacteria are joined to a non-toxic protein produced by tetanus bacteria. The protein helps to stimulate the immune system in a broader way so it responds well to the vaccine. This gives a better immune response in individuals of all ages.

The polio component is made from several virus strains, grown in the laboratory using animal cells. The virus strains are inactivated (killed) with formaldehyde. They are then adsorbed onto adjuvants, which are ingredients to help the vaccine create a stronger immune response. For polio, the adjuvants are either aluminium phosphate or aluminium hydroxide. See more information on animal cell strains in vaccine production. As the polio vaccine is inactivated, it cannot cause polio. This was a very small risk with the live, oral polio vaccine used in the UK until 2004.

The diphtheria part of the vaccine is a toxoid vaccine. The diphtheria toxin is purified, inactivated (killed) and treated with formaldehyde to convert it into harmless diphtheria toxoid. For the most part, the vaccine is not given on its own, but in combination vaccines, for example with tetanus toxoid and pertussis.

As with diphtheria, the tetanus component is a toxoid vaccine, treated with formaldehyde, then absorbed onto an adjuvant to improve people’s immune response to the vaccine.

Countries which used the same 5-in-1 vaccine as the UK may have had different vaccination schedules. In the UK, the three doses were given as close together as possible to give babies early protection from pertussis (whooping cough). This disease can be particularly severe in very young babies, so the earlier they are protected the better. 

 
 

 

Page last updated Wednesday, November 29, 2023