HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------- WARNINGS AND PRECAUTIONS -----------------------

These highlights do not include all the information needed to use KINRIX • If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior
safely and effectively. See full prescribing information for KINRIX. vaccine containing tetanus toxoid, the decision to give KINRIX should be
based on potential benefits and risks. (5.1)
KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis • The tip caps of the prefilled syringes contain natural rubber latex which
Adsorbed and Inactivated Poliovirus Vaccine) Suspension for may cause allergic reactions. (5.2)
Intramuscular Injection • Syncope (fainting) can occur in association with administration of
Initial U.S. Approval: 2008 injectable vaccines, including KINRIX. Procedures should be in place to
avoid falling injury and to restore cerebral perfusion following syncope.
----------------------------- INDICATIONS AND USAGE----------------------------
(5.3)
A single dose of KINRIX is indicated for active immunization against
diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the • If temperature ≥105°F, collapse or shock-like state, or persistent,
diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the inconsolable crying lasting ≥3 hours have occurred within 48 hours after
fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged receipt of a pertussis-containing vaccine, or if seizures have occurred
4 through 6 years (prior to the seventh birthday) whose previous DTaP within 3 days after receipt of a pertussis-containing vaccine, the decision
vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 to give KINRIX should be based on potential benefits and risks. (5.4)
doses and INFANRIX for the fourth dose. (1) • For children at higher risk for seizures, an antipyretic may be
administered at the time of vaccination with KINRIX. (5.5)
------------------------- DOSAGE AND ADMINISTRATION -----------------------
A single intramuscular injection (0.5 mL). (2.2) -------------------------------- ADVERSE REACTIONS ------------------------------
• The most frequently reported solicited local reaction (>50%) was
----------------------- DOSAGE FORMS AND STRENGTHS---------------------- injection site pain. Other common solicited local reactions (≥25%) were
Single-dose, prefilled syringes containing a 0.5-mL suspension for injection. redness, increase in arm circumference, and swelling. (6.1)
(3) • Common solicited general adverse reactions (≥15%) were drowsiness,
-------------------------------- CONTRAINDICATIONS ------------------------------ fever (≥99.5°F), and loss of appetite. (6.1)
• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any To report SUSPECTED ADVERSE REACTIONS, contact
diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or
vaccine, or to any component of KINRIX, including neomycin and [Link].
polymyxin B. (4.1)
• Encephalopathy within 7 days of administration of a previous pertussis- -------------------------------- DRUG INTERACTIONS-------------------------------
containing vaccine. (4.2) Do not mix KINRIX with any other vaccine in the same syringe. (7.1)
• Progressive neurologic disorders. (4.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2023

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE 6.2 Postmarketing Experience
2 DOSAGE AND ADMINISTRATION 7 DRUG INTERACTIONS
2.1 Preparation for Administration 7.1 Concomitant Vaccine Administration
2.2 Recommended Dose and Schedule 7.2 Immunosuppressive Therapies
3 DOSAGE FORMS AND STRENGTHS 8 USE IN SPECIFIC POPULATIONS
4 CONTRAINDICATIONS 8.4 Pediatric Use
4.1 Hypersensitivity 11 DESCRIPTION
4.2 Encephalopathy 12 CLINICAL PHARMACOLOGY
4.3 Progressive Neurologic Disorder 12.1 Mechanism of Action
5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY
5.1 Guillain-Barré Syndrome 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
5.2 Latex 14 CLINICAL STUDIES
5.3 Syncope 14.1 Immunological Evaluation
5.4 Adverse Reactions following Prior Pertussis 14.2 Concomitant Vaccine Administration
Vaccination 15 REFERENCES
5.5 Children at Risk for Seizures 16 HOW SUPPLIED/STORAGE AND HANDLING
5.6 Preventing and Managing Allergic Vaccine Reactions 17 PATIENT COUNSELING INFORMATION
6 ADVERSE REACTIONS *Sections or subsections omitted from the full prescribing information are not
6.1 Clinical Trials Experience listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus,
pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis
(DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in
children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine
doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis
Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses
1
and INFANRIX for the fourth dose.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration
Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension
does not occur with vigorous shaking. Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution and container
permit. If either of these conditions exists, the vaccine should not be administered.
Attach a sterile needle and administer intramuscularly.
Do not administer this product intravenously, intradermally, or subcutaneously.
2.2 Recommended Dose and Schedule
KINRIX is to be administered as a 0.5-mL dose by intramuscular injection. The preferred site of
administration is the deltoid muscle of the upper arm.
KINRIX may be used for the fifth dose in the DTaP immunization series and the fourth dose in
the IPV immunization series in children aged 4 through 6 years (prior to the seventh birthday)
whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first
3 doses and INFANRIX for the fourth dose [see Indications and Usage (1)].

3 DOSAGE FORMS AND STRENGTHS

KINRIX is a suspension for injection available in 0.5-mL single-dose prefilled TIP-LOK
syringes.

4 CONTRAINDICATIONS
4.1 Hypersensitivity
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-,
tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of KINRIX,
including neomycin and polymyxin B, is a contraindication to administration of KINRIX [see
Description (11)]. Because of the uncertainty as to which component of the vaccine might be
responsible, no further vaccination with any of these components should be given. Alternatively,
such individuals may be referred to an allergist for evaluation if immunization with any of these
components is considered.
4.2 Encephalopathy
Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days
of administration of a previous dose of a pertussis-containing vaccine that is not attributable to
another identifiable cause is a contraindication to administration of any pertussis-containing
vaccine, including KINRIX.

2
4.3 Progressive Neurologic Disorder
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or
progressive encephalopathy, is a contraindication to administration of any pertussis-containing
vaccine, including KINRIX. Pertussis vaccine should not be administered to individuals with
such conditions until a treatment regimen has been established and the condition has stabilized.

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome
If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus
toxoid, the decision to give any tetanus toxoid-containing vaccine, including KINRIX, should be
based on careful consideration of the potential benefits and possible risks. When a decision is
made to withhold tetanus toxoid, other available vaccines should be given, as indicated.
5.2 Latex
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic
reactions.
5.3 Syncope
Syncope (fainting) can occur in association with administration of injectable vaccines, including
KINRIX. Syncope can be accompanied by transient neurological signs such as visual
disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to
avoid falling injury and to restore cerebral perfusion following syncope.
5.4 Adverse Reactions following Prior Pertussis Vaccination
If any of the following reactions occur in temporal relation to receipt of a pertussis-containing
vaccine, the decision to give any pertussis-containing vaccine, including KINRIX, should be
based on careful consideration of the potential benefits and possible risks:
• Temperature of ≥40.5oC (105oF) within 48 hours not due to another identifiable cause;
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
• Persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours;
• Seizures with or without fever occurring within 3 days.
When a decision is made to withhold pertussis vaccination, other available vaccines should be
given, as indicated.
5.5 Children at Risk for Seizures
For children at higher risk for seizures than the general population, an appropriate antipyretic
may be administered at the time of vaccination with a pertussis-containing vaccine, including
KINRIX, and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

3
5.6 Preventing and Managing Allergic Vaccine Reactions
Prior to administration, the healthcare provider should review the patient’s immunization history
for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an
assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of
immediate allergic reactions must be immediately available should an acute anaphylactic
reaction occur.

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical
trials of another vaccine and may not reflect the rates observed in practice.
A total of 4,013 children were vaccinated with a single dose of KINRIX in 4 clinical trials. Of
these, 381 children received a non-U.S. formulation of KINRIX (containing ≤2.5 mg
2-phenoxyethanol per dose as preservative).
The primary study (Study 048), conducted in the United States, was a randomized, controlled
clinical trial in which children aged 4 to 6 years were vaccinated with KINRIX (n = 3,156) or
control vaccines (INFANRIX and IPOL vaccine [IPV, Sanofi Pasteur SA]; n = 1,053) as a fifth
DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses
of IPOL. Subjects also received the second dose of U.S.-licensed measles, mumps, and rubella
(MMR) vaccine (Merck & Co., Inc.) administered concomitantly, at separate sites.
Data on adverse events were collected by parents/guardians using standardized forms for 4
consecutive days following vaccination with KINRIX or control vaccines (i.e., day of
vaccination and the next 3 days). The reported frequencies of solicited local reactions and
general adverse reactions in Study 048 are presented in Table 1.
In 3 studies (Studies 046, 047, and 048), children were monitored for unsolicited adverse events,
including serious adverse events that occurred in the 31-day period following vaccination, and in
2 studies (Studies 047 and 048), parents/guardians were actively queried about changes in the
child’s health status, including the occurrence of serious adverse events, through 6 months post-
vaccination.

4
Table 1. Percentage of Children Aged 4 to 6 Years Reporting Solicited Local or
General Adverse Reactions within 4 Days of Vaccinationa with KINRIX or Separate
Concomitant Administration of INFANRIX and IPV when Coadministered with
MMR Vaccine (Study 048) (Total Vaccinated Cohort)
Adverse Reaction KINRIX INFANRIX + IPV
Local b n = 3,121-3,128 n = 1,039-1,043
c
Pain, any 57 53
d
Pain, Grade 2 or 3 14 12
d c
Pain, Grade 3 2 1
Redness, any 37 37
Redness, ≥50 mm 18 20
Redness, ≥110 mm 3 4
Arm circumference increase, any 36 38
Arm circumference increase, >20 mm 7 7
Arm circumference increase, >30 mm 2 3
Swelling, any 26 27
Swelling, ≥50 mm 10 12
Swelling, ≥110 mm 1 2
General n = 3,037-3,120 n = 993-1,036
Drowsiness, any 19 18
e
Drowsiness, Grade 3 1 1
Fever, ≥99.5°F 16 15
c
Fever, >100.4°F 7 4
Fever, >102.2°F 1 1
Fever, >104°F 0 0
Loss of appetite, any 16 16
f
Loss of appetite, Grade 3 1 1
IPV = Inactivated poliovirus vaccine (Sanofi Pasteur SA); MMR = Measles, mumps, and
rubella vaccine (Merck & Co., Inc.).
Total Vaccinated Cohort = All vaccinated subjects for whom safety data were available.
n = Number of children with evaluable data for the reactions listed.
a
Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b
Local reactions at the injection site for KINRIX or INFANRIX.
c
Statistically higher than comparator group (P <0.05).
d
Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing
normal daily activities.
e
Grade 3 defined as preventing normal daily activities.
f
Grade 3 defined as not eating at all.
In Study 048, KINRIX was non-inferior to INFANRIX with regard to swelling that involved

5
>50% of the injected upper arm length and that was associated with a >30 mm increase in mid-
upper arm circumference within 4 days following vaccination (upper limit of 2-sided 95%
Confidence Interval for difference in percentage of KINRIX [0.6%, n = 20] minus INFANRIX
[1.0%, n = 11] ≤2%).
Serious Adverse Events
Within the 31-day period following study vaccination in 3 studies (Studies 046, 047, and 048) in
which all subjects received concomitant MMR vaccine (U.S.-licensed MMR vaccine [Merck &
Co., Inc.] in Studies 047 and 048, non—U.S.-licensed MMR vaccine in Study 046), 3 subjects
(0.1% [3/3,537]) who received KINRIX reported serious adverse events (dehydration and
hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3%
[4/1,434]) who received INFANRIX and inactivated poliovirus vaccine (Sanofi Pasteur SA)
reported serious adverse events (cellulitis, constipation, foreign body trauma, fever without
identified etiology).
6.2 Postmarketing Experience
In addition to reports in clinical trials for KINRIX, the following adverse reactions have been
identified during postapproval use of KINRIX. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably estimate their frequency
or establish a causal relationship to vaccination.
General Disorders and Administration Site Conditions
Injection site vesicles.
Nervous System Disorders
Syncope.
Skin and Subcutaneous Tissue Disorders
Pruritus.
Additional adverse reactions reported following postmarketing use of INFANRIX, for which a
causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid
reactions, anaphylaxis, angioedema, and urticaria; apnea; collapse or shock-like state (hypotonic-
hyporesponsive episode); convulsions (with or without fever); lymphadenopathy; and
thrombocytopenia.

7 DRUG INTERACTIONS
7.1 Concomitant Vaccine Administration
In U.S. clinical trials, KINRIX was administered concomitantly with the second dose of MMR
vaccine (Merck & Co., Inc.); in one of these trials (Study 055), KINRIX was also administered
concomitantly with varicella vaccine (Merck & Co., Inc.) [see Clinical Studies (14.2)].

6
When KINRIX is administered concomitantly with other injectable vaccines, they should be
given with separate syringes. KINRIX should not be mixed with any other vaccine in the same
syringe.
7.2 Immunosuppressive Therapies
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic
drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune
response to KINRIX.

8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use
Safety and effectiveness of KINRIX in children younger than 4 years and children aged 7 to
16 years have not been evaluated. KINRIX is not approved for use in persons in these age
groups.

11 DESCRIPTION
KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated
Poliovirus Vaccine) is a noninfectious, sterile vaccine for intramuscular administration. Each
0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg
of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of
pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus
(Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The
diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX
and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.
The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in
Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium
tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine
materials used in these extracts are sourced from countries which the United States Department
of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform
encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by
ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.
The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis
(B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are
isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and
flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT
is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with
formaldehyde.
Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are
individually adsorbed onto aluminum hydroxide.

7
The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of
the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey
kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during
VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has
determined neither have nor are at risk of BSE. After clarification, each viral suspension is
purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated
with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate.
Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing
antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis
components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked
immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the
inactivated poliovirus component is determined by using the D-antigen ELISA and by a
poliovirus-neutralizing cell culture assay on sera from previously immunized rats.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg
aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each
dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween
80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing
process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B
per dose.
The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with
natural rubber latex.
KINRIX does not contain a preservative.

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Diphtheria
Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C.
diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the
diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving
some degree of protection; a level of 0.1 IU/mL is regarded as protective.1
Tetanus
Tetanus is an acute toxin-mediated disease caused by a potent exotoxin released by C. tetani.
Protection against disease is due to the development of neutralizing antibodies to the tetanus
toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays,
is considered the minimum protective level.2,3 A level of ≥0.1 IU/mL is considered protective.4

8
Pertussis
Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role
of the different components produced by B. pertussis in either the pathogenesis of, or the
immunity to, pertussis is not well understood. There is no well-established serological correlate
of protection for pertussis. The efficacy of the pertussis component of KINRIX was determined
in clinical trials of INFANRIX administered as a 3-dose series in infants (see INFANRIX
prescribing information).
Poliomyelitis
Poliovirus is an enterovirus that belongs to the picornavirus family. Three serotypes of poliovirus
have been identified (Types 1, 2, and 3). Neutralizing antibodies against the 3 poliovirus
serotypes are recognized as conferring protection against poliomyelitis disease.5

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
KINRIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of
fertility.

14 CLINICAL STUDIES
14.1 Immunological Evaluation
In a U.S. multicenter study (Study 048), 4,209 children were randomized in a 3:1 ratio to receive
either KINRIX or INFANRIX and IPV (Sanofi Pasteur SA) administered concomitantly at
separate sites. Subjects also received MMR vaccine (Merck & Co., Inc.) administered
concomitantly at a separate site. Subjects were children aged 4 through 6 years who previously
received 4 doses of INFANRIX, 3 doses of IPV, and 1 dose of MMR vaccine. Among subjects in
both vaccine groups combined, 49.6% were female; 45.6% of subjects were White, 18.8%
Hispanic, 13.6% Asian, 7.0% Black, and 15.0% were of other racial/ethnic groups.
Levels of antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus
antigens were measured in sera obtained immediately prior to vaccination and 1 month (range:
31 to 48 days) after vaccination (Table 2). The co-primary immunogenicity endpoints were anti-
diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses,
and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month
after vaccination. KINRIX was shown to be non-inferior to INFANRIX and IPV administered
separately, in terms of booster responses to DTaP antigens and post-vaccination GMTs for anti-
poliovirus antibodies (Table 2).

9
Table 2. Pre-Vaccination Antibody Levels and Post-Vaccinationa Antibody Responses
following KINRIX Compared with Separate Concomitant Administration of INFANRIX
and IPV in Children Aged 4 to 6 Years when Coadministered with MMR Vaccine
(Study 048) (ATP Cohort for Immunogenicity)
KINRIX INFANRIX + IPV
n = 787-851 n = 237-262
Anti-diphtheria Toxoid
Pre-vaccination % ≥0.1 IU/mL (95% CI)b 87.7 (85.3, 89.9) 85.5 (80.6, 89.5)
b
Post-vaccination % ≥0.1 IU/mL (95% CI) 100 (99.6, 100) 100 (98.6, 100)
c d
% Booster Response (95% CI) 99.5 (98.8, 99.9) 100 (98.6, 100)
Anti-tetanus Toxoid
Pre-vaccination % ≥0.1 IU/mL (95% CI)b 87.8 (85.4, 90.0) 88.2 (83.6, 91.8)
b
Post-vaccination % ≥0.1 IU/mL (95% CI) 100 (99.6, 100) 100 (98.6, 100)
c d
% Booster Response (95% CI) 96.7 (95.2, 97.8) 93.9 (90.2, 96.5)
Anti-PT
% Booster Response (95% CI)e 92.2 (90.2, 94.0)d 92.6 (88.7, 95.5)
Anti-FHA
% Booster Response (95% CI)e 95.4 (93.7, 96.7)d 96.2 (93.1, 98.1)
Anti-pertactin
% Booster Response (95% CI)e 97.8 (96.5, 98.6)d 96.9 (94.1, 98.7)
Anti-poliovirus 1
Pre-vaccination % ≥1:8 (95% CI)b 88.3 (85.9, 90.4) 85.1 (80.1, 89.2)
b
Post-vaccination % ≥1:8 (95% CI) 99.9 (99.3, 100) 100 (98.5, 100)
f
Post-vaccination GMT (95% CI) 2,127 (1,976, 2,290) 1,685 (1,475, 1,925)
Anti-poliovirus 2
Pre-vaccination % ≥1:8 (95% CI)b 91.8 (89.7, 93.6) 87.0 (82.3, 90.8)
b
Post-vaccination % ≥1:8 (95% CI) 100 (99.6, 100) 100 (98.5, 100)
f
Post-vaccination GMT (95% CI) 2,265 (2,114, 2,427) 1,818 (1,606, 2,057)
Anti-poliovirus 3
Pre-vaccination % ≥1:8 (95% CI)b 84.7 (82.0, 87.0) 85.0 (80.1, 89.1)
b
Post-vaccination % ≥1:8 (95% CI) 100 (99.5, 100) 100 (98.5, 100)
f
Post-vaccination GMT (95% CI) 3,588 (3,345, 3,849) 3,365 (2,961, 3,824)
ATP = According-to-protocol; CI = Confidence Interval; GMT = Geometric mean antibody titer;
IPV = Inactivated poliovirus vaccine (Sanofi Pasteur SA); MMR = Measles, mumps, and rubella
vaccine (Merck & Co., Inc.).
n = Number of subjects with available results.
a
One-month blood sampling, range 31 to 48 days.
b
Seroprotection defined as anti-diphtheria toxoid and anti-tetanus toxoid antibody
concentrations ≥0.1 IU/mL by ELISA and as anti-poliovirus Type 1, Type 2, and Type 3

10
 antibody titer ≥1:8 by micro-neutralization assay for poliovirus.
c
Booster response: In subjects with pre-vaccination <0.1 IU/mL, post-vaccination concentration
≥0.4 IU/mL. In subjects with pre-vaccination concentration ≥0.1 IU/mL, an increase of at least
4 times the pre-vaccination concentration.
d
KINRIX was non-inferior to INFANRIX + IPV based on booster response rates (upper limit of
2-sided 95% CI on the difference of INFANRIX + IPV minus KINRIX ≤10%).
e
Booster response: In subjects with pre-vaccination <5 EL.U./mL, post-vaccination
concentration ≥20 EL.U./mL. In subjects with pre-vaccination ≥5 EL.U./mL and
<20 EL.U./mL, an increase of at least 4 times the pre-vaccination concentration. In subjects
with pre-vaccination ≥20 EL.U./mL, an increase of at least 2 times the pre-vaccination
concentration.
f
KINRIX was non-inferior to INFANRIX + IPV based on post-vaccination anti-poliovirus
antibody GMTs adjusted for baseline titer (upper limit of 2-sided 95% CI for the GMT ratio
[INFANRIX + IPV:KINRIX] ≤1.5).
14.2 Concomitant Vaccine Administration
In a U.S. study (Study 055) that enrolled children aged 4 to 6 years, KINRIX was administered
concomitantly at separate sites with MMR vaccine (Merck & Co., Inc.) (n = 237) or with MMR
vaccine and varicella vaccine (Merck & Co., Inc.) (n = 239). Immune responses to the antigens
contained in KINRIX were measured approximately 1 month (28 to 48 days) after vaccination.
Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus
(Type 1, 2, and 3) after the receipt of KINRIX administered concomitantly with MMR vaccine
and varicella vaccine were non-inferior to immune responses following concomitant
administration of KINRIX administered with MMR vaccine.

15 REFERENCES
1. Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA,
eds. Vaccines. 5th ed. Saunders; 2008:139-156.
2. Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin
SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.
3. Department of Health and Human Services, Food and Drug Administration. Biological
products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule.
Federal Register. December 13, 1985;50(240):51002-51117.
4. Centers for Disease Control and Prevention. General Recommendations on Immunization.
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR.
2006;55(RR-15):1-48.
5. Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect
to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal
KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration.

11
 Current issues and perspectives. New York, NY: The New York Academy of Sciences;
1995:289-299.

16 HOW SUPPLIED/STORAGE AND HANDLING

KINRIX is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (packaged
without needles):
NDC 58160-812-43 Syringe in Package of 10: NDC 58160-812-52
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has
been frozen.

17 PATIENT COUNSELING INFORMATION

Provide the following information to the parent or guardian:
• Inform of the potential benefits and risks of immunization with KINRIX.
• Inform about the potential for adverse reactions that have been temporally associated with
administration of KINRIX or other vaccines containing similar components.
• Give the Vaccine Information Statements, which are required by the National Childhood
Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available
free of charge at the Centers for Disease Control and Prevention (CDC) website
([Link]/vaccines).
INFANRIX, KINRIX, PEDIARIX, and TIP-LOK are trademarks owned by or licensed to the
GSK group of companies. The other brand listed is a trademark owned by or licensed to its
respective owner and is not owned by or licensed to the GSK group of companies. The maker of
this brand is not affiliated with and does not endorse the GSK group of companies or its
products.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617, and
GSK Vaccines GmbH
Marburg, Germany, U.S. License 1617
Distributed by GlaxoSmithKline
Durham, NC 27701

12
©2023 GSK group of companies or its licensor.
KNX:17PI

13