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Haemophilus influenzae type b


Introducing Haemophilus influenzae type B (Hib)

conjugate vaccine into national immunization services

learning disabilities, and difficulties in Studies have shown that vaccination


movement is not uncommon among reduces the risk of invasive Hib disease

The bacterium, Haemophilus

those who survive infection. Studies have in young children by >90%, and in

influenzae type B (Hib), is an

important cause of infections in also shown that Hib accounts for up to some cases, has even led to protection

one-quarter of the severe pneumonia of unimmunized populations by

infants and young children; severe

cases in young children in developing “herd immunity”.

disease in adults due to Hib is

countries. WHO estimates that without

uncommon. Where it has been studied Since 1998,, WHO has recommended that

carefully, Hib is typically the leading vaccination 400 000 children die each

year of Hib disease. Hib conjugate vaccine be included in

cause of acute bacterial meningitis in routine infant immunization services in

infants and children less than five years Safe and effective vaccines against Hib all countries where the resources permit

old, accounting for one-third to one- infections exist. These vaccines have been its use and the burden of disease is

half of all cases of bacterial meningitis

routinely used to vaccinate infants in established. This document provides an

in this age group. Bacterial meningitis many countries for over 10 years. The outline of information needed to

is fatal unless treated immediately experience with these vaccines has shown implement a national decision to

with antibiotics. Even with proper that they are very safe and highly introduce Hib vaccine, with a particular

treatment 3-25% of affected children

effective for preventing severe Hib disease, focus on issues relevant to countries

may die. Permanent disability with including meningitis and pneumonia. applying for support for the introduction

sequelae that include deafness, of Hib vaccine from The Vaccine Fund.

World Health Organization
1211 Geneva 27
Objectives The currently available pentavalent Administration

vaccine requires the reconstitution of

The primary objective of Hib Hib conjugate vaccine is administered

lyophilized Hib conjugate vaccine with

immunization strategies should be to by intramuscular or subcutaneous

prevent severe Hib disease in infants and liquid DTP-hepatitis B vaccine. In this injection in the anterolateral aspect of

instance, the Hib vaccine should be

young children because nearly all severe the thigh (infants) or the deltoid muscle

reconstituted only with the

Hib disease occurs in children less than (older children). It can be given safely at

DTP-hepatitis B vaccine produced

five years of age, and the majority of the the same time as other vaccines such as

deaths occur among infants. by the same manufacturer. Similarly, DTP, polio, hepatitis B, measles, BCG,

there is at least one DTP-Hib

and yellow fever vaccines. If given as a

combination that requires the

Immunization strategies combination with DTP in the same

reconstitution of the lyophilized Hib

Universal infant immunization
immunization. syringe, it should be given

conjugate vaccine with liquid DTP intramuscularly.

Immunization of all infants through vaccine, and the Hib vaccine should be

routine services is the highest priority for reconstituted only with the DTP

Injection equipment

all countries. This strategy has been vaccine produced by the same

proven effective in many areas. The injection equipment for Hib


conjugate vaccine is the same type as

Catch-up vaccination of older

Combination vaccines that contain Hib that for DTP or hepatitis B:

children. (Note: The Vaccine Fund does conjugate vaccine:

not provide funding to purchase vaccine · can be used anytime all of the · 0.5 ml (auto-disable), 1.0ml or

for catch-up vaccination.) antigens in the vaccine are indicated 2.0ml syringe

Children aged greater than 12 months by the schedule; · 25mm, 22 or 23 gauge needle

can be protected with just a single dose of · cannot be used before 6 weeks of age Sterile auto-disable (AD) injection

Hib conjugate vaccine. At the time of (e.g. for the birth dose of hepatitis B devices are recommended.

introduction, some countries have chosen vaccine) because the

to conduct one-time national campaigns Dosage

immunogenicity of the DTP and

to vaccinate all children 1 to 5 years of Hib components will be reduced if

The standard paediatric dose is 0.5 ml.

age with a single dose of Hib conjugate given before this age.

vaccine. This approach may provide some Vaccine procurement


protection to older children but should be

undertaken only if it does not draw In most countries, Hib conjugate vaccine

Immunization of infants with Hib

procured through The Vaccine Fund will

resources away from infant conjugate vaccine is usually

be supplied through the UNICEF

immunization. Because the risk of Hib accomplished by giving the vaccine at

procurement mechanism.

disease falls sharply after age 5 years, the same ages as DTP vaccine, either as a

vaccination of persons older than age

separate injection or in combination. The number of Hib conjugate vaccine

5 years should not be undertaken. In general, infants should receive a

doses required is estimated using the size

primary dose schedule of 3 doses of of the birth cohort, the coverage rate for

Vaccine formulations Hib conjugate vaccine in the first year of DTP and the number of doses in the

Hib conjugate vaccines are available life. Doses of Hib conjugate vaccine immunization schedule. These

should be administered at least 4 weeks

in several different formulations. calculations should also include wastage

apart. Children older than one year of and the size of the reserve stock.

They can be obtained as a liquid or

freeze-dried powder (lyophilized), age require only a single dose of Hib

in single or multi-dose vials, and as conjugate vaccine. Booster doses of Hib Presentation

monovalent vaccines (Hib conjugate conjugate vaccine may be given to

Hib conjugate vaccines are generally

children in the second year of life, but

vaccine only) or in combination available in single-dose and multi-dose

successful control of Hib disease does not

with other routine vaccines (e.g. DTP, (2 and 10 dose) vials, and in liquid and

DTP-hepatitis B). require a booster dose.

lyophilized formulations.

Storage and shipping volume It also serves as a tool for improving the Information, education, and

practices of health centres when wastage communication needs

Storage volumes (vial plus packet

rates are found to be unacceptably high.

containing the vial plus any other When introducing Hib conjugate

packaging) for some available vaccines

Strategies to reduce vaccine wastage vaccine into national immunization

are: include the following: services, information, education and

· careful planning of vaccine ordering communication (IEC) efforts are

· 32.3 cm3 per dose for liquid Hib in

and distribution; important from the beginning in order

single-dose vials,

· use of both single-dose and multi- to generate support and commitment

· 9.7 cm3 per dose for lyophilized Hib for the new vaccine and to assure that

dose vials ;

in single-dose vials, ○

the vaccine is appropriately handled

· careful maintenance of the cold

(Diluent for freeze-dried vaccines doubles and administered. The primary target

the necessary storage space at the health chain;

audiences for IEC efforts are decision-

centre level.) · implementation of WHO’s multi- makers/opinion leaders, health care staff,

· 13.8 cm3 per dose for liquid Hib or dose vial policy, when appropriate. and the general public (including

DTP-Hib vaccine in 10 dose vials, parents).

Injection safety

· 9.7 cm3 per dose for DTP-HepB-Hib

Hib conjugate vaccine procured through

vaccine in 2 dose vials. What information is needed to

The Vaccine Fund will be supplied with

For comparison, the WHO standard assess Hib disease burden?

auto-disable syringes and safety boxes.

storage volumes for DTP vaccine are Various tools are available from the WHO

Additional disposable syringes will be

2.5 cm3 per dose in 20 dose vials and needed for lyophilized vaccines that regional office which use existing local

3.0 cm3 per dose in 10 dose vials. require reconstitution. Managers at each and regional data to estimate the burden

of Hib disease. As a result, disease burden

level are responsible for ensuring that

Cold chain issues studies will not be needed in most

adequate supplies are available at all

times. Attention should also be given to countries.

The storage temperature for Hib

conjugate vaccines is the same as for the proper use and disposal of the safety

DTP and hepatitis B vaccines, from boxes used to collect these materials. How should Hib conjugate

2°C to 8°C. vaccine be phased into the

Revision of reporting forms and existing infant immunization

Adding Hib conjugate vaccine to the

training materials services?

national immunization programme will

require: An important element of integrating Hib The easiest way to introduce Hib

· an assessment of cold chain storage vaccination into national conjugate vaccine is to simply begin

capacity and cold chain procedures immunization services is to revise vaccinating each infant that comes for

training and informational materials,

at all administrative levels; and, routine DTP vaccination. Some

forms used to monitor and evaluate the countries may wish to consider one-time

· development and implementation

programme, and vaccination cards. catch-up vaccination of older children

of plans to modify cold chain

(<2 years or <5 years of age). This will

storage capacity and cold chain

lead to a more immediate reduction in

procedures, if needed.

Hib cases but will be more expensive and

Monitoring and reducing vaccine somewhat more complicated to achieve.


Monitoring vaccine wastage becomes

increasingly important as the costs of the

vaccine rise. Monitoring increases

ordering accuracy and reduces wastage by

providing reliable data for estimating the

number and size of vials to be ordered.

Which type of Hib conjugate Use of combination vaccines may offer safety. Also, the introduction of this new
vaccine is most suitable? certain programmatic advantages. vaccine against serious childhood illness
These include: represents an opportunity to renew
The following issues should be considered community interest in all routine
when planning for the procurement of • a decrease in the number of
injections required per visit vaccinations.
Hib conjugate vaccine:
(and thus decrease the number of
• the existing immunization schedule Budgeting for Hib conjugate
auto-disable needles and syringes
and planned Hib conjugate vaccine required); and
schedule; vaccine introduction
• a decrease in the amount of space Capital and recurrent costs related to the
• the proper mix of monovalent/
required for cold chain storage and introduction of Hib conjugate vaccine
combination vaccines in single/
transport. should be estimated and included in the
multi-dose vials;
annual EPI budget. Additional capital
• formulation (lyophilized vs. liquid); How can the addition of Hib costs might include: investment in
• total number of injections per visit; conjugate vaccine be used to means of transport, cold chain
• impact on local vaccine production; strengthen the national equipment and sterilization equipment.
and immunization services? Investment in an information campaign
• cost. targeted at the general public should
The introduction of Hib conjugate
also be included. Additional recurrent
vaccine into the routine services should
costs include: vaccines, auto-disable
be used as an opportunity to strengthen
injection devices, salaries, transportation
the existing services. Programme
(petrol and maintenance), training,
elements that need particular attention
cold chain maintenance, safe disposal of
for the introduction of Hib conjugate
waste, disease surveillance and other
include stock management,
supplies, such as laboratory media and
reducing vaccine wastage, and injection

Ordering code: WHO/V&B/01.29

Printed October 2001

This document is available on the Internet at:

Copies may be requested from:

World Health Organization
Department of Vaccines and Biologicals
CH-1211 Geneva 27, Switzerland
• Fax: + 41 22 791 4227 • Email: •

© World Health Organization 2001

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