Kinrix

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Kinrix

Quick Facts

Property Description
Active Ingredients Diphtheria toxoid, Tetanus toxoid, Acellular pertussis antigens, Inactivated poliovirus
Form Suspension for injection
Pharmacological Class Immunizing agent; Combination vaccine
Target Population Children 4 through 6 years of age
Origin Biological product (inactivated components)

What Type of Vaccine is Kinrix?

Kinrix is a combination vaccine classified as a sterile, noninfectious biological product belonging to the pharmacological class of Immunizing agents. It is structurally identified as a DTaP-IPV vaccine, signifying its ability to provide protection against four diseases: diphtheria, tetanus, acellular pertussis (whooping cough), and poliomyelitis. Kinrix is an inactivated vaccine because it is formulated using only killed viral components and purified bacterial proteins known as toxoids, which means the vaccine itself cannot transmit the diseases it is meant to prevent. This combination vaccine, manufactured by GlaxoSmithKline Biologicals (GSK), is clinically recognized for use in the routine immunization schedule, serving as both the fifth DTaP and fourth IPV dose.

Understanding the Kinrix Composition and Form

The vaccine is supplied as an adsorbed suspension for injection intended for intramuscular administration. The active ingredients include Diphtheria toxoid and Tetanus toxoid, along with purified acellular pertussis antigens (such as pertactin and filamentous hemagglutinin) and three types of Inactivated Poliovirus. These components are combined with the adjuvant Aluminum hydroxide within an aqueous base. The adsorbed nature of the formulation helps the body build a more durable defense against the four targeted pathogens.

What is the General Purpose of Kinrix?

The general purpose of Kinrix is to induce active immunity and provide prophylactic protection against these four specific diseases. It is explicitly indicated for the pediatric population aged 4 through 6 years, acting as a crucial reinforcement of the immune memory established in infancy. A typical neutral use scenario involves administering Kinrix to a child before they enter school to maintain robust immunity against diphtheria, tetanus, pertussis, and polio, thereby completing the recommended vaccination series.

What side effects are possible with Kinrix?

Possible Side Effects and Safety Information

Official regulatory documents classify adverse reactions to Kinrix (DTaP-IPV) by frequency and the body system affected. Most reactions are local or systemic events that occur soon after administration.

Classification Domain Officially Documented Information
Most Frequent Reactions Pain, redness, and swelling at the injection site are the most frequently reported local reactions. Common systemic events include fever, drowsiness (somnolence), fatigue, and loss of appetite.
System-Organ Classes Adverse reactions are primarily grouped under General Disorders and Administration Site Conditions (e.g., local pain, fever) and Nervous System Disorders (e.g., drowsiness).
Time-Related Patterns Most solicited local and systemic adverse events are noted to occur within 48 hours following administration and typically resolve within 48 to 72 hours.

Serious adverse reactions are rare but documented in the official safety profile. These include severe allergic reactions, such as anaphylaxis, as well as specific events associated with the pertussis component, such as Hypotonic-Hyporesponsive Episodes (HHE) or encephalopathy occurring within seven days of a previous dose. Seizures (with or without fever) are also listed as a potential serious reaction.

Safety restrictions establish formal boundaries for use. A history of a severe allergic reaction (anaphylaxis) to any component of Kinrix is a formal contraindication. The vaccine is also contraindicated in individuals who have experienced encephalopathy within seven days following a previous dose of a pertussis-containing vaccine not attributable to another cause. The regulatory documentation includes specific safety notes for children with a history of fever-associated seizures and those with progressive neurological disorders.

Overdose and Emergency Response

The official regulatory documents for Kinrix (DTaP-IPV) address accidental over-administration primarily through the identification and emergency management of severe, acute systemic reactions rather than a traditional pharmacological overdose profile. The profile focuses on manifestations that require immediate medical attention and are relevant to the vaccine’s components.

Over-administration scenarios are associated with the risk of severe, documented outcomes, including anaphylaxis (a life-threatening allergic reaction) and Hypotonic-Hyporesponsive Episode (HHE), which presents as a collapse or shock-like state. Other manifestations listed in regulatory warnings that necessitate urgent assessment include a temperature 40.5 C (105 F), seizures (with or without fever), and persistent, inconsolable crying lasting three hours or more within 48 hours of administration.

Immediate medical help is required for any signs of a severe allergic reaction, such as difficulty breathing, hives, or swelling of the face, tongue, or throat. Official prescribing information mandates that Epinephrine hydrochloride solution (1:1,000) and appropriate equipment must be immediately available for use in case an acute hypersensitivity reaction occurs. Furthermore, supportive management involves implementing procedures to prevent injury and restore cerebral perfusion following syncope (fainting). No specific pharmacological antidote is known or described for over-administration of this product in the pediatric population.

Therapeutic Uses of Kinrix

What Kinrix Treats: Main Uses and Benefits

Prophylaxis Against Life-Threatening Infectious Disease

Kinrix is applied in contexts that support prophylactic protection and supports defense against four diseases: diphtheria, tetanus (lockjaw), acellular pertussis (whooping cough), and poliomyelitis. Its primary purpose is relevant for easing the risk of conditions characterized by periods of heightened symptoms and the symptom clusters they are associated with, such as neuromuscular paralysis, uncontrollable muscle spasms, and severe respiratory distress. This is commonly used across domains where additional symptomatic support is needed to help prevent functional stability from becoming affected.


Reinforcing Protection in Children Aged 4 Through 6 Years

Kinrix is relevant in contexts involving the pediatric population aged 4 through 6 years to help manage the risk of developing these disruptive symptom manifestations. It contributes to maintaining prophylactic protection against the target pathogens. This assists with maintaining functional stability when symptoms are more noticeable (by being present in the community) and is relevant to contexts where additional symptomatic support is sought before the child enters school and group settings.

“This application assists with maintaining functional stability when symptoms are more noticeable, by providing support against four major infectious threats.”

Quick Fact: Pediatric Prophylaxis Support

Property Description
Main Use Context Prophylaxis against infectious conditions
Symptom Domains Prevention of neurological damage, severe respiratory distress, and debilitating muscle spasms
Target Population Children aged 4 through 6 years
General Benefit Supports maintenance of protective antibody levels

Eligibility and Restrictions for Use

Who Can and Cannot Use Kinrix?

Kinrix's use is strictly defined by regulatory age limitations and specific contraindications documented in official labeling.

Approved and Non-Approved Populations

Kinrix is indicated solely for children 4 through 6 years of age. It is intended to be administered as the fifth dose of DTaP and the fourth dose of Inactivated Poliovirus Vaccine (IPV) in the childhood vaccination series. The vaccine is not indicated for individuals younger than 4 years old or those 7 years of age and older.

Absolute Contraindications

Use of Kinrix is contraindicated and must be avoided in certain populations, based on medical history:

  • Individuals with a history of severe allergic reaction (anaphylaxis) to any component of the vaccine or to a previous dose of a DTaP or IPV vaccine.
  • Individuals who developed encephalopathy (e.g., coma, decreased consciousness) not attributable to another cause within 7 days after a previous dose of any pertussis-containing vaccine.

Conditional Use and Restrictions

Vaccination should be deferred for a child with a moderate or severe acute illness with or without fever until they have recovered. Additionally, caution is advised for individuals with a history of Guillain-Barré Syndrome (GBS) occurring within 6 weeks of a previous tetanus toxoid-containing vaccine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Kinrix, an inactivated combination vaccine, primarily has officially documented pharmacodynamic interactions that affect the development of the immune response, rather than metabolic (CYP450) or transporter-mediated interactions.

Pharmacodynamic and Immunological Interactions

The most clinically significant documented interaction involves Immunosuppressive Therapies. Medicines such as chemotherapy, high-dose corticosteroids, or radiation therapy may result in a suboptimal immune response to the vaccine. This interaction pattern indicates that the expected development of protective antibodies may be impaired in individuals receiving these agents, a key regulatory caution.

Conversely, the regulatory profile establishes specific co-administration patterns with other vaccines. Kinrix may be administered concomitantly with other age-appropriate vaccines, such as the Measles, Mumps, and Rubella (MMR) vaccine, provided they are given at separate injection sites. This pattern is documented as not interfering with the protective immune response to the primary antigens.

Administration Timing and Product Separation

Constraint Type Officially Documented Restriction
Timing-based Rule Administration must be postponed in the presence of an acute moderate or severe illness (with or without fever).
Managing Post-Vaccination Fever For children identified as being at higher risk for seizures, antipyretics (such as acetaminophen) may be considered at the time of vaccination to reduce the possibility of fever following administration.
Contraindicated Combinations None are formally listed as drug-drug combinations due to interaction risk.

These domains reflect the standardized regulatory classification for biological products, focusing on preserving immunological integrity and establishing clear constraints for concurrent administration.

Mechanism of Action

Kinrix is a multicomponent vaccine formulated to induce an active acquired immune response against specific bacterial and viral targets. Its mechanism is centered on the presentation of purified, non-replicating antigenic components to the host's immune system.

The Diphtheria and Tetanus toxoids are chemically modified, detoxified proteins. Following administration, these toxoids are processed by antigen-presenting cells (APCs), such as dendritic cells and macrophages. The APCs subsequently present the peptide fragments via MHC class II molecules to T-helper cells (TH). This engagement initiates T-cell dependent B-cell activation. Activated B cells differentiate into plasma cells that synthesize and secrete neutralizing antibodies specific to the Diphtheria toxin and Tetanospasmin neurotoxin.

The acellular pertussis components (Pertussis Toxin, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2 & 3) also act as antigens. Their uptake and processing by APCs similarly drive the expansion of Pertussis-specific TH cells and the differentiation of B cells into plasma cells, leading to the systemic production of IgG antibodies that bind to the Bordetella pertussis virulence factors.

The inactivated poliovirus components (Types 1, 2, and 3) contain non-infectious viral capsids. These are recognized as foreign antigens, stimulating the activation of Poliovirus-specific TH cells and B cells. This results in the generation of memory B cells and the secretion of neutralizing antibodies that bind to the respective poliovirus serotypes.

The ultimate system-level physiological consequence across all components is the establishment of immunologic memory and a circulating reservoir of pathogen-specific antibodies, preparing the host for a future, accelerated, and robust secondary immune response.

Dosage and Administration Information

How Kinrix is Used: Official Administration Guidelines

Kinrix is a combination vaccine administered according to a specific, standardized protocol established by regulatory authorities. Its use is strictly defined by the required administration route, dosage, age range, and timing within the pediatric immunization schedule.


Administration Protocol

The vaccine is supplied as a sterile suspension for injection in a single-dose volume of 0.5 mL. The full 0.5 mL dose is administered only once, as the vaccine is not subject to dose titration or adjustment. Kinrix is intended to serve as the fifth dose in the DTaP series and the fourth dose in the IPV series, acting as a critical booster to complete the primary childhood immunization series.

Instruction Detail
Route of Administration Intramuscular (IM) injection only. It is explicitly instructed not to administer the product intravenously, subcutaneously, or intradermally.
Preferred Site The deltoid muscle of the upper arm is the preferred injection site.
Age Restriction Indicated for children aged 4 through 6 years (prior to the seventh birthday) who have received specific prior DTaP vaccines.
Timing & Interval The dose must be given at a minimum of six months after the patient received their fourth dose of DTaP.

Preparation Requirements

Before administration, the syringe or vial containing the suspension must be shaken vigorously to ensure the liquid is a uniform, turbid, white suspension. This preparation step is mandatory, and the product must be discarded if the correct appearance is not achieved after shaking. The administration procedure is singular; the vaccine does not involve cycles, long-term maintenance, or patient-administered dosing.

Recent Clinical Evidence

Research evidence / Overview of Studies for Kinrix

Evidence for Use as the DTaP-IPV Booster Dose in Children

Kinrix was primarily evaluated through pivotal Phase III randomized controlled trials (RCTs). These studies are designed to compare the immune responses prompted by a new medical product against those prompted by established alternatives in a highly controlled environment. Kinrix was studied for its use as the fifth DTaP and fourth IPV dose in children between 4 and 6 years of age.

Research examined Kinrix for its role in supporting the immune memory established during the initial vaccination series. The main goal of these studies was to assess the body's immune response to the combination vaccine. Researchers focused on whether the combined shot supported the production of antibody levels that meet the concentrations pre-defined by regulators for seroprotection.


Immunogenicity Research and Comparator Trials

Researchers primarily monitored immunogenicity as the central outcome in the trials. This means they measured the concentration of specific antibodies in the blood one month after the children received the injection. For the diphtheria, tetanus, and poliovirus components, the studies monitored the percentage of children who achieved pre-defined seroprotection levels. For the pertussis components, the studies monitored the rise in antibodies from the levels present before vaccination.

The trials were designed as non-inferiority trials. This type of research examined whether the antibody response observed after Kinrix was similar enough (non-inferior) to the response observed after administering the equivalent separate vaccines concurrently. Research so far indicates that these studies reported that the children reached specific protective antibody concentrations one month after vaccination. These findings described the patterns observed in the studies and contributed to the overall evidence considered by regulators.


Long-term Follow-up and Durability of Immune Response

The research studies typically measured the primary immune outcomes (antibody levels) at a short-term interval, often one month after the administration of the booster dose. This short-term follow-up duration was sufficient for assessing the immediate immune response, which provides insight into the ability to reach target antibody levels.

However, existing studies provide limited information for long-term outcomes regarding the persistence of protective antibody levels or the overall durability of the immune response over several years following this booster dose. Data are not fully established from the initial pivotal trials on how long antibody concentrations are maintained in this specific age group until subsequent doses are needed.

Frequently Asked Questions (FAQ)

Common questions about Kinrix (FAQ)


Q: How long does the protection from Kinrix last?

Official research studies primarily assessed the immune response, such as antibody levels, one month after the booster dose. While this confirmed the initial immune boost, the official product information notes that data on long-term outcomes, extending multiple years past the initial booster dose, are generally limited from the pivotal trials. The vaccine is intended to reinforce the immune protection established during the child's primary vaccination series.


Q: Can Kinrix cause irritability or fussiness in children?

Official safety information lists common systemic events like drowsiness (sleepiness) and fatigue. While irritability or fussiness are not explicitly listed as the most common side effects, similar reactions like drowsiness are documented. The official safety profile mentions rare, serious reactions following previous pertussis-containing vaccines, such as a period of persistent, inconsolable crying.


Q: Are there any known long-term side effects associated with Kinrix?

Regulatory documents indicate that most common side effects, such as pain or fever, occur within 48 hours and generally resolve within 72 hours. Serious but rare adverse events are monitored within seven days of administration. Official product information notes that data on long-term outcomes, extending multiple years past the initial booster dose, are generally limited from the pivotal trials.


Q: Can Kinrix be given at the same time as the flu shot?

Yes, official guidance states that Kinrix may generally be administered at the same time as other age-appropriate vaccines, including the influenza (flu) vaccine. When administering Kinrix and another vaccine simultaneously, regulatory guidance advises using separate injection sites.


Q: Can a child still get Kinrix if they have a mild cold?

Official product information states that vaccination must be deferred, or postponed, for any child experiencing a moderate or severe acute illness, regardless of whether they have a fever. If a child has only a mild illness, the administration of Kinrix is generally determined by the healthcare provider based on their professional judgment.


Q: Why can't infants or babies receive Kinrix?

Kinrix is strictly indicated and approved for use only in children aged 4 through 6 years. Official labeling states that the safety and effectiveness of this specific formulation have not been confirmed by regulatory authorities for children younger than four years old.


Q: What kind of ingredients in Kinrix can cause an allergic reaction?

A severe allergic reaction (anaphylaxis) to any component of Kinrix is a formal reason not to use the vaccine (a contraindication). Specific trace substances from the manufacturing process, such as the antibiotics neomycin and polymyxin B, are listed in the official ingredients as potential causes of an allergic response.


Q: How quickly does the body start to build immunity after a Kinrix dose?

Studies that assessed how the vaccine works (immunogenicity) measured the required antibody levels in children approximately one month after the Kinrix dose was given. This timeframe is used to confirm that the vaccine provided the intended immune boost and reinforced the body's protection.


Q: Is Kinrix generally considered safe for children with a history of seizures?

Official regulatory guidance states that caution should be exercised when administering Kinrix to children with a personal or family history of fever-associated seizures. For these children, the option of administering a fever-reducing medicine at the time of vaccination may be considered to help manage post-vaccination fever.


Q: Why is the pertussis component called 'acellular' in DTaP?

The term acellular is used because this type of pertussis vaccine contains only purified, non-living parts (antigens) of the Bordetella pertussis bacteria. This is a distinction from older vaccine types, as the acellular version uses only specific components—such as Pertussis Toxin and Filamentous Hemagglutinin—to stimulate the immune response.


Q: What is the definition of a 'contraindication' for Kinrix?

A contraindication is a specific condition or circumstance noted in the official regulatory labeling that indicates the vaccine should not be administered. This is because the risk of a serious adverse event, such as a severe allergic reaction or encephalopathy, outweighs any potential benefit for the patient in that specific situation.


Q: What are the inactive ingredients in the Kinrix vaccine?

The officially listed inactive ingredients include aluminum hydroxide, which is an adjuvant used to enhance the immune response, and sodium chloride. Additionally, the vaccine may contain trace amounts of residual substances from the manufacturing process, such as formaldehyde, polysorbate 80, neomycin sulfate, and polymyxin B.


Q: Why are DTaP and Polio combined into one vaccine?

The main regulatory rationale for combination vaccines like Kinrix is to reduce the number of injections a child receives. This is intended to streamline the routine immunization schedule.


Q: What is the difference between Kinrix and Pediarix?

Kinrix is a four-component vaccine (DTaP-IPV) intended exclusively for the booster dose in children aged 4 through 6 years. Pediarix, in contrast, is a five-component vaccine that includes protection against Hepatitis B, and it is indicated for the initial primary series (doses 1-3) in infants and younger children.


Q: Is Kinrix the same as Quadracel?

Kinrix and Quadracel are both regulatory-approved DTaP-IPV vaccines used for the booster dose in children aged 4 through 6 years. They are, however, different products manufactured by separate companies. Official labeling indicates they have variations, including differences in the specific quantities of antigens they contain.


Q: Are there different brand names for the Kinrix combination?

Yes, the combination vaccine that protects against DTaP and Polio is available under different brand names. In the US market, this combination is available as both Kinrix (manufactured by GlaxoSmithKline) and Quadracel (manufactured by Sanofi Pasteur).


Q: Does Kinrix have to be given at a specific time of year?

No, the timing for Kinrix administration is not dictated by the season or time of year. It is a part of the standard, routine childhood immunization schedule, and its administration is based purely on the child's age and documented vaccination history.


Q: Is there a patient information leaflet available for Kinrix?

According to official guidance, there is generally no single, specific Vaccine Information Statement (VIS) issued for the combination vaccine Kinrix. Instead, healthcare providers are typically instructed to provide the current, separate VISs for the individual component vaccines: the DTaP VIS and the IPV VIS.


Q: Is Kinrix mandatory or recommended for school entry?

The components found in Kinrix—DTaP and Polio protection—are recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) for children before they enter kindergarten. The status of whether these immunizations are mandatory is determined by individual state and local school requirements.


Q: What happens if a child misses their scheduled Kinrix shot?

Official guidance indicates that if a child misses their scheduled Kinrix shot, the dose is typically administered as soon as feasible. This falls under the concept of catch-up schedules, which ensures the child meets the minimum age and interval requirements necessary to complete the immunization series for all components.


Q: Can Kinrix be given to children who have a known egg allergy?

Yes, according to official information, Kinrix does not contain egg proteins or any residual components derived from eggs. Therefore, a known egg allergy is not listed as a contraindication for the use of Kinrix.


Q: Does Kinrix contain thimerosal?

No, Kinrix is supplied in single-dose, preservative-free formulations. Thimerosal is not added as a preservative to the vaccine. Regulatory documents note that the final product may contain an extremely small, trace amount of mercury resulting from the manufacturing process.


Q: Can Kinrix be used interchangeably with other DTaP/Polio boosters?

Yes, but its use is guided by the official labeling and prior vaccination history. Kinrix is specifically indicated for children whose prior DTaP doses were administered with the vaccines Infanrix and/or Pediarix. Compliance with regulatory guidance is required regarding the brand of the previously administered doses.


Q: Does Kinrix protect against tetanus from all types of wounds?

The vaccine causes the body to develop active protection (antibodies) against the Tetanus neurotoxin, which is the substance that causes the disease. Maintaining the full vaccination series over time is essential to ensure adequate protection.

How should Kinrix be stored and disposed of?

How to Store and Dispose of Kinrix?

Kinrix must be stored according to strict regulatory guidelines to maintain its stability. The vaccine requires continuous refrigeration, with the official mandated storage temperature range being mathbf2 C to mathbf8 C (mathbf36 F to mathbf46 F).

Storage Requirements

Constraint Requirement
Temperature Store between 2 C and 8 C.
Freezing Do not freeze. The product must be discarded if it has been frozen.
Protection Store in the original packaging, protected from light.
Safety Keep the vaccine out of the sight and reach of children.

Disposal Instructions

Expired or unused Kinrix must be discarded in compliance with state and federal regulations for pharmaceutical waste. The product should not be thrown into general household waste or flushed down the sink, as mandated by official disposal protocols.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Kinrix found in:

A-Z Index: