Published Assessment Report

INFANRIX HEXA

INFORMASI PRODUK

Nama Obat : INFANRIX HEXA

Zat Aktif : Setiap dosis (0,5 mL) mengandung:
 Pertusis antigens:
 Pertussis toxoid (PT) 25 mcg
 Filamentous haemogglutinin (FHA) 25 mcg
 Pertactin (PRN) 8 mcg
 Diphteria toxoid (D) ≥30 IU
 Tetanus toxoid (T) ≥40 IU
 r-DNA Hepatitis B surface antigen (HBsAg) 10 mcg
 Inactivated Polio Virus type 1 40 DU
 Inactivated Polio Virus type 2 8 DU
 Inactivated Polio Virus type 3 32 DU
 Conjugated of Haemophilus influenza type b capsular
polysaccharide (PRP) and tetanus toxoid 10 mcg (PRP) and
25 mcg (T)
Bentuk Sediaan : Injeksi
Kategori Registrasi : Variasi Major (Perubahan Posologi)
Indikasi yang disetujui : Infanrix hexa is indicated for primary and booster vaccination of
infants against diphtheria, tetanus, pertussis, hepatitis B,
poliomyelitis and haemophilus influenza type b.

PENGANTAR

Infanrix hexa merupakan vaksin terdaftar yang berisi kombinasi dari vaksin Diphtheria
Pertussis Tetanus, Polio, Hepatitis B dan Hemophilus influenza tipe b. Infanrix hexa saat ini
mengajukan perubahan posologi berupa penambahan posologi sebagai berikut:
- Pre term infants born after at least 24 weeks of gestational age
- Primary vaccination: 3 doses
- Booster vaccination: A booster dose may be given.
- General consideration (for both full term and pre term infants):
There should be an interval of at least one month between primary doses. When
giving a booster dose, this should be at least 6 months after the last priming dose
and preferably before 18 months of age.

Sandingan posologi Infanrix hexa yang disetujui dan yang diajukan adalah sebagai berikut:

Posologi yang disetujui Posologi yang diajukan

Primary vaccination

The primary vaccination schedule consist of The primary vaccination schedule consist of
three doses of 0,5 mL (e.g. at 2,3,4 months; two or three doses (of 0,5 mL) which should
3,4,5 months; 2,4,6 months) or two doses be administered according to the official
(e.g. at 3,5 months). There should be an recommendations (see Pharmacodynamic
interval of at least 1 month between doses. Effects for schedules evaluated in clinical
trials). Infanrix hexa can be considered for the
booster if the antigen composition is in
accordance with the official
recommendations.
Primary Booster General
vaccination vaccination consideration
Full term infants
3 dose A booster  There
dose may be should be
given an interval
of at least 1
month
between
primary
doses.
 When
giving a
booster
dose, this
should be at
least 6
months
after the
last priming
dose and
preferably
before 18
months of
age.
2 doses A booster  There
dose must should be
be given. an interval
of at least 1
month
between
primary
doses.
 When
giving a
booster
dose, this
should be at
least 6
months
after the
last priming
dose and
 preferably
between 11
and 13
months of
age.
Preterm infants born after at least 24
weeks of gestational age
3 doses A booster  There
dose must should be
be given an interval
of at least 1
month
between
primary
doses.
 When
giving a
booster
dose, this
should be at
least 6
months
after the
last priming
dose and
preferably
before 18
months of
age.
The Expanded Program on Immunisation The Expanded Program on Immunisation
schedule (at 6, 10, 14 weeks of age) may schedule (at 6, 10, 14 weeks of age) may only
only be used if a dose of hepatitis B vaccine be used if a dose of hepatitis B vaccine has
has been given at birth. been given at birth.

Locally established immunoprophylatic Where a dose of hepatitis B vaccine is given

measures against hepatitis B should be
maintained. Where a dose of hepatitis B
vaccine is given at birth, Infanrix hexa can
be used as a replacement for supplementary
doses of hepatitis B vaccine from the age of
6 weeks. If a second dose of hepatitis B
vaccine is request before this age,
monovalent hepatitis B vaccine should be
used.
at birth, Infanrix hexa can be used as a
replacement for supplementary doses of
hepatitis B vaccine from the age of 6 weeks. If
a second dose of hepatitis B vaccine is
required before this age, monovalent hepatitis
B vaccine should be used.
Locally established immunoprophylactic
measures against hepatitis B should be
maintained.

Booster vaccination
After a vaccination with 2 doses (e.g at 3 &
5 months of age) of Infanrix hexa, a booster
dose must be given at least 6 months after
 the last priming dose, preferably between
11 and 13 months of age.

After vaccination with 3 doses (e.g. at 2,3,4

months of age; 3,4,5 months of age; 2,4,6
months of age) of Infanrix hexa a booster
dose may be given at least 6 months after
the last priming dose, preferably before 18
months of age.

Booster doses should be given in

accordance with the official
recommendations.

Infanrix hexa can be considered for the

booster if the composition is in accordance Other combinations of antigen have been
with the official recommendations. studied in clinical trials following primary
vaccination with Infanrix hexa and may be
Other combinations of antigen have been used for a booster dose : DTPa, DTPa+Hib,
studied in clinical trials following primary DTPa-IPV+Hib, DTPa-HBV-IPV+Hib.
vaccination with Infanrix hexa and may be
used for a booster dose: DTPa, DTPa+Hib,
DTPa-IPV+Hib, DTPa-HBV-IPV+Hib.

Berdasarkan perubahan posologi yang diajukan tersebut di atas, maka evaluasi difokuskan pada
studi klinik penggunaan Infanrix hexa pada bayi pre term untuk menunjukkan efikasi dan
keamanan vaksin ini pada kelompok bayi pre term.

STUDI KLINIK

Studi klinik yang diserahkan untuk penambahan posologi pada bayi prematur ini adalah
sebagai berikut:
1. 3 studi vaksinasi primer (studi no. DTPa-HBV-IPV-070, DTPa-HBV-IPV-090 dan 10PN-
PD-DIT-015).
2. 2 studi vaksinasi booster (studi no. DTPa-HBV-IPV-083 dan DTPa-HBV-IPV-103
BST:090
3. 2 studi lain yaitu 10PN-PD-DIT-016 BST:015 dan studi DTPa-130 tidak dievaluasi
mengingat produk uji dalam studi tersebut bukan Infanrix hexa.
EVALUASI

1. Pemberian Infanrix hexa sebagai vaksinasi primer dengan jadwal pemberian 3 dosis (2,4,6
bulan) pada bayi prematur (usia kehamilan <37 minggu) menunjukkan imunogenisitas
yang baik (seroproteksi di atas 90% untuk semua antigen).
2. Pemberian Infanrix hexa sebagai vaksinasi booster dengan jadwal pemberian 1 dosis (18-
20 bulan atau 18-24 bulan) pada bayi prematur (usia kehamilan <37 minggu) menunjukkan
imunogenisitas yang baik (seroproteksi di atas 88% untuk semua antigen).
3. Profil keamanan pemberian Infanrix hexa pada bayi prematur dapat ditoleransi.

KEPUTUSAN

Posologi Infanrix hexa untuk bayi pre term yang diajukan dapat diterima.