Boostrix

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Boostrix

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Method of action: Vaccine

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Boostrix

Quick Facts

Property Description
Active Ingredient Diphtheria toxoid, Tetanus toxoid, Acellular Pertussis Antigens
Form Suspension for Intramuscular Injection (Pre-filled Syringe)
Pharmacological Class Vaccine, Active Immunizing Agent
Common Use Booster immunization against Diphtheria, Tetanus, and Pertussis
Origin Biological Medicinal Product; Manufactured by GlaxoSmithKline Biologicals
Status Prescription Only (Rx)

What is Boostrix and What Class of Vaccine is it?

Boostrix is a biological medicinal product that functions as an active immunizing agent, formally designated as Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed. It is a prescription-only Tdap vaccine manufactured by GlaxoSmithKline Biologicals, typically supplied in a pre-filled syringe. This non-live vaccine is engineered for use as a booster vaccination in individuals aged 10 years and older. The product is a reduced-antigen content vaccine, a key differentiating feature, meaning the diphtheria and pertussis components are intentionally dosed lower than in the vaccines used for the primary childhood series, which is appropriate for reinforcing established immune memory in older patients.

Composition: A Combination of Acellular Toxoids and Antigens

The core composition of this injectable suspension contains five essential active ingredients. These components are purified, detoxified forms of the disease-causing agents, including diphtheria toxoid, tetanus toxoid, and three distinct acellular pertussis antigensPertussis toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN). The incorporation of these multiple acellular pertussis antigens is intended to elicit a broad and high-quality immune response. The immunizing components are stabilized by being adsorbed onto aluminium hydroxide and aluminium phosphate, which serve as adjuvants to enhance the resulting immune reaction.

General Purpose: Booster Protection Against Three Diseases

The exclusive purpose of Boostrix is to provide active booster immunization and ensure sustained seroprotection against diphtheria, tetanus (Lockjaw), and pertussis (Whooping cough). A particularly important application is its use for immunization during the third trimester of pregnancy. This practice is utilized to help prevent pertussis in newborns, as receiving Boostrix helps refresh and maintain the protective antibody levels established during earlier vaccinations, providing passive protection to infants in the first vulnerable weeks of life.

What side effects are possible with Boostrix?

Possible Side Effects and Safety Information

The most commonly reported adverse reactions following the administration of Boostrix are generally local and systemic, based on clinical trial data.

Common Adverse Reactions

The most frequent side effects (reported in 15% or more of individuals in clinical trials, depending on age group) involve local injection site reactions (pain, redness, and swelling), headache, and fatigue. Gastrointestinal symptoms, such as nausea, vomiting, diarrhea, and/or abdominal pain, are also commonly reported. In the elderly population (aged 65 years and older), pain at the injection site is the most common solicited adverse reaction.

System-Organ Class Common Adverse Reactions (ge15% frequency in at least one trial group)
General Disorders Pain, Redness, Swelling at injection site; Fatigue; Headache
Gastrointestinal Nausea, Vomiting, Diarrhea, Abdominal Pain

Serious and Clinically Significant Safety Concerns

Contraindications include a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any tetanus, diphtheria, or pertussis-containing vaccine. The vaccine is also contraindicated in individuals who developed encephalopathy not attributable to another cause within seven days of a previous dose of a pertussis-containing vaccine.

Warnings and Precautions address several rare but serious neurological events. Healthcare providers should assess the risk/benefit before administering Boostrix to individuals who have experienced Guillain-Barré syndrome within six weeks of a prior tetanus toxoid-containing vaccine. Deferral of vaccination is generally advised for individuals with progressive or unstable neurologic conditions. Additionally, syncope (fainting) may occur following administration of injectable vaccines. An Arthus-type hypersensitivity reaction following a prior tetanus toxoid-containing vaccine requires a minimum 10-year interval before receiving Boostrix.

As with any vaccine, appropriate medical treatment must be immediately available to manage acute allergic reactions.

Overdose and Emergency Response

Overdose and when to seek help

The information regarding overdosage of Boostrix is based exclusively on official regulatory documentation.

Overdose Scope

Regulatory Focus Area Official Regulatory Documentation Statement
Documented Overdose Manifestations Adverse events reported following the administration of an excessive dose are described as similar to those reported with the normal dose of the vaccine.
Physiological Systems Affected Events requiring immediate attention, such as anaphylaxis (severe allergic reaction), encephalopathy, and syncope (fainting), are highlighted in the regulatory literature as potential severe outcomes of vaccine administration.
Emergency-Response Statements Appropriate medical treatment to manage acute allergic reactions must be immediately available following the administration of the vaccine.
Management Measures Management of overdosage is officially described as providing symptomatic and supportive treatment. Contacting a regional poison control centre for consultation is the mandated procedure for a suspected drug overdose.

When Immediate Medical Help is Required

Immediate medical attention must be sought for symptoms associated with a severe or life-threatening allergic reaction, which may include swelling of the face, throat, or tongue, difficulty breathing, dizziness, or a fast heartbeat. These manifestations represent acute, life-threatening scenarios that require urgent care.

The official overdose profile is defined by the regulatory statement that clinical events following an overdosage are non-distinct from those of a standard dose. Consequently, the focus is entirely on emergency readiness and the recognition of severe, known complications that require the patient to seek immediate medical attention, as dictated by governmental prescribing information.

Therapeutic Uses of Boostrix

Boostrix is a vaccine indicated to support active booster immunization against three specific bacterial diseases: tetanus (commonly known as lockjaw), diphtheria, and pertussis (or whooping cough). This use applies to individuals aged 10 years and older who have previously received a primary vaccination series.

The vaccine may offer a meaningful benefit by helping the body develop protection against these conditions, which can lead to serious complications.

Boostrix also has an approved role in immunization during the third trimester of pregnancy. Administering the vaccine during this time may help prevent pertussis in infants younger than two months of age, a population at high risk for severe outcomes from the disease. Decisions regarding its use should be based on a professional therapeutic overview for active immunity and maternal immunization as described in the official indications. Information regarding the approved uses of the vaccine is available within the product indications.

Eligibility and Restrictions for Use

Boostrix is a booster vaccine whose use is officially defined by age, pregnancy status, and documented medical history, based on regulatory labeling (FDA, TGA, EMA).

Approved and Excluded Populations

Category Official Regulatory Status (Based on Label)
Approved Age Range Individuals aged 10 years and older for active booster immunization.
Special Indication Pregnant individuals during the third trimester to prevent pertussis in infants younger than two months of age.
Absolute Contraindications Prohibited in individuals with a known history of anaphylaxis to any component or following a previous dose of any tetanus, diphtheria, or pertussis vaccine. Also prohibited if encephalopathy of unknown cause occurred within seven days of a prior pertussis-containing vaccine.

Restrictions and Cautions

Certain conditions require vaccination to be deferred or administered with caution:

  • Deferral is required for acute severe febrile illness or progressive/unstable neurologic conditions.
  • Individuals with a history of Arthus-type hypersensitivity reaction to a tetanus toxoid-containing vaccine should not receive Boostrix unless at least 10 years have passed since the last dose.
  • An expected full immune response may not be obtained in immunosuppressed persons (including those receiving therapy).

What should I know about interactions with other medicines?

Boostrix interacts with other medicines primarily through pharmacodynamic means, as described in official government regulatory documents. The most significant interaction involves immunosuppressive therapies, including high-dose corticosteroids, chemotherapy agents, and certain biologic treatments. Co-administration with these therapies may result in a reduced or inadequate expected immune response to the vaccine antigens. This loss of expected protection is a pharmacodynamic finding, meaning the therapy interferes with the vaccine's function. The regulatory caution specifically applies to individuals with primary or acquired immunodeficiency or those actively receiving these immunosuppressive regimens. The official label notes that, when possible, vaccination should be completed at least two weeks prior to the initiation of immunosuppressive therapy.

Interactions with Other Injectable Products

Official labeling establishes strict procedural constraints for combining Boostrix with other injectable products. If administered simultaneously with any other vaccine or immunoglobulin, the products must always be given at separate anatomical sites. Furthermore, there is a formal restriction that Boostrix must not be mixed with any other vaccine or product in the same syringe or vial. Studies have documented that co-administration with certain other non-live vaccines—such as the Human Papilloma Virus vaccine or the Meningococcal ACWY conjugate vaccine—results in no clinically relevant interference with the antibody response to most components. No specific interactions with food, alcohol, or herbal products are documented in the official prescribing information for this vaccine.

Mechanism of Action

Boostrix, an inactivated vaccine, functions as a biological target for the recipient's adaptive immune system by delivering detoxified antigens. The vaccine contains non-infectious diphtheria toxoid, tetanus toxoid, and three purified Bordetella pertussis antigens: pertussis toxoid (PT), filamentous haemagglutinin (FHA), and pertactin (PRN). These antigens are adsorbed onto aluminum salts, which function as an adjuvant to enhance the immune response.

Upon intramuscular administration, the antigens are captured by antigen-presenting cells (APCs) in the local tissue, which then migrate to draining lymph nodes. Within the lymph nodes, APCs present the antigens to T lymphocytes and B lymphocytes via receptor-ligand interaction. This initiates the molecular and intracellular pathways of adaptive immunity, leading to clonal expansion of antigen-specific T and B cells.

This cellular proliferation results in the differentiation of B cells into plasma cells, which engage in antibody production (a downstream cascade). The resulting high concentration of specific antibodies (antitoxins and anti-pertussis proteins) constitutes the system-level physiological consequence of generating immunological memory against these bacterial components.

Dosage and Administration Information

Official Administration Guidelines for Boostrix

The Tdap vaccine, Boostrix, is administered as a single 0.5-mL dose for booster immunization, following specific preparation and procedural steps.

Procedural Steps

  1. Inspection: The vaccine must be visually inspected for foreign particulate matter or discoloration. If either condition exists, the product should not be used.
  2. Preparation: The suspension must be shaken vigorously immediately before use to obtain a homogeneous, turbid, white suspension. If vigorous shaking does not result in resuspension, the product must be discarded.
  3. Administration: Boostrix is for intramuscular (IM) use only. The injection should be administered into the deltoid muscle of the upper arm. It must never be administered intravascularly (into a blood vessel).
    • For patients with a bleeding disorder or thrombocytopenia, the vaccine may be administered subcutaneously (under the skin) if this is consistent with official recommendations.

Dosing and Age-Specific Rules

Administration Context Dosage Age/Timing Rules
Routine Booster A single 0.5-mL dose For individuals aged 10 years and older. Repeat vaccination intervals are generally every 10 years, as per official recommendations.
Maternal Use A single 0.5-mL dose Administer to pregnant individuals during the third trimester of pregnancy. The use of the vaccine as a primary series has not been established.
Wound Management A single 0.5-mL dose May be administered for tetanus prophylaxis in a tetanus-prone wound if at least 5 years have elapsed since the patient's previous tetanus toxoid-containing vaccine.

If Boostrix is to be given at the same time as other injectable vaccines, the products must always be administered at different injection sites.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Boostrix


The Primary Evidence Base: Booster Immunization

The initial clinical evaluation for Boostrix involved Randomized Controlled Trials (RCTs) and other study types, particularly for its use as a booster vaccine in adolescents and adults. Researchers were primarily interested in immunogenicity, which describes the ability to generate an immune response (antibody levels), rather than tracking large numbers of participants to see if they avoided clinical disease.

Trial findings described that the measured antibody levels for Tetanus and Diphtheria components were monitored against levels generally accepted by regulators as correlates of protection. Research so far describes that the evidence used in the vaccine's review process focuses on these antibody measurements.

Outcomes Examined in Immunogenicity Trials

Studies measured the achievement of specific Seroprotection rates for Tetanus and Diphtheria antibodies. For the Pertussis components, the focus was on Seroconversion—the shift from having low antibody levels to higher ones after receiving the booster. These measurements provided context related to how the vaccine was observed to elicit an immune response.


Evidence Supporting Use During Pregnancy

The research base for using Boostrix during the third trimester of pregnancy draws primarily from Observational Studies and Real-World Data. Researchers used observational studies to explore whether maternal vaccination was associated with patterns of pertussis incidence in newborns, a population highly vulnerable to severe outcomes from the disease.

Findings indicate that maternal vaccination was associated with the presence of specific antibodies in the infant. Observational research highlights that patterns of lower reported rates of Pertussis were examined in infants whose mothers received the vaccine during the third trimester, compared to those whose mothers did not receive the vaccine.


Gaps and Uncertainties in the Research Record

For adolescents and adults, the primary evidence relies on antibody levels (immunogenicity) rather than definitive, large-scale clinical efficacy trials. Clinical characteristics are often evaluated based on accepted correlates of protection. Additionally, there is limited information for long-term outcomes, particularly concerning the full rate of antibody decay. Data for certain groups, such as individuals with specific chronic health conditions, is limited compared to the general population studied.

Key Studies & References

  1. Summary of Product Characteristics - Boostrix suspension for injection in pre-filled syringe (European Regulatory Document)

Frequently Asked Questions (FAQ)

Common questions about Boostrix (FAQ)

Q: How long does the protection from Boostrix last after getting the shot?

Protection from the tetanus and diphtheria components is intended to be long-lasting. For this reason, official public health guidelines recommend receiving a booster shot generally every 10 years throughout adulthood to help maintain protective antibody levels against these diseases. Studies indicate that protection against pertussis (whooping cough) may begin to fade more quickly than the other two components.

Q: Can Boostrix cause a fever, and if so, how high can it get?

Yes, fever, also known as pyrexia, is documented in regulatory safety information as a common reaction following the shot. Fever reactions reported in trials are generally mild and temporary. However, official safety data notes that a high fever (above 102.2 F or 39.0 C) is a rare, but listed, potential reaction.

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

The primary evidence base for Boostrix focuses on immediate reactions following vaccination and the short-term immune response. Regulatory documents note that data regarding certain long-term outcomes, such as the full pattern of antibody decay, are currently limited. The official product label is updated to include rare events reported over time through post-marketing surveillance.

Q: Does Boostrix contain mercury or thimerosal?

According to the official product information, Boostrix is manufactured without thimerosal as a preservative. However, because thimerosal is used in some parts of the manufacturing process, a trace amount (less than 0.3 mu g of mercury per dose) may be present in the final product.

Q: What is the difference between Boostrix and Adacel (another Tdap vaccine)?

Both Boostrix and Adacel are official Tdap vaccines approved to provide booster protection against tetanus, diphtheria, and pertussis. Official regulatory bodies have noted that Boostrix is approved for a slightly broader age range for the booster indication, specifically for individuals aged 10 years and older, including those aged 65 years and older.

Q: Can people with egg allergies receive Boostrix?

Official regulatory documents, including the full prescribing information, do not list egg allergy as either a contraindication or a general precaution for receiving the Boostrix vaccine.

Q: Where can I find the official regulatory information about Boostrix?

Official regulatory documents, such as the full Prescribing Information (Package Insert) and the Vaccine Information Statement (VIS), are publicly available. These resources can typically be accessed on government websites maintained by agencies like the FDA (DailyMed) or the CDC in the United States.

Q: What should I do if I miss the recommended timing for a Boostrix shot?

Official regulatory and public health guidelines state that if a person misses the recommended timing for a booster dose, they do not need to restart the entire vaccination series. The guidance is that the booster dose should be administered at the next appropriate healthcare visit.

Q: How soon after getting Boostrix does the protective effect begin?

Clinical studies examine the onset of the immune response, which is a process that occurs over time following the shot. For individuals who receive the vaccine during pregnancy, official guidelines note that it generally takes approximately two weeks for the mother's antibody levels to be boosted and then transferred to the infant, which may help prevent pertussis in the newborn.

Q: Is the tetanus component in Boostrix for tetanus prevention only?

The tetanus toxoid component in Boostrix is an active immunizing agent intended solely to help prevent tetanus (lockjaw). The vaccine is specifically formulated for prophylaxis (prevention) and is not indicated for treating an active tetanus infection or any other medical condition.

Q: Do regulatory agencies require follow-up studies after a vaccine like Boostrix is approved?

Yes, regulatory agencies like the FDA and public health organizations like the CDC maintain continuous post-licensure surveillance. They monitor vaccine safety and adverse events through systems such as the Vaccine Adverse Event Reporting System (VAERS) to ensure safety and gather more data.

Q: Why might a healthcare professional recommend Boostrix over Td?

The Td vaccine provides protection only against tetanus and diphtheria. Boostrix is a Tdap vaccine that provides protection against all three diseases—tetanus, diphtheria, and pertussis (whooping cough)—making it the most appropriate option for a routine booster for most adolescents and adults when pertussis protection is desired.

Q: What is the difference between an adverse event and a side effect reported for Boostrix?

Official reporting systems define an adverse event as any health problem experienced following a vaccination, whether or not it was caused by the vaccine itself. A side effect is a type of adverse event specifically shown in clinical trials or studies to be causally linked to the vaccine.

Q: Does Boostrix contain any human blood products?

The official product description lists the active immunizing components (toxoids, antigens) and inactive ingredients (adjuvants and residual chemicals). It does not list any human blood or plasma products as components in the vaccine formulation.

Q: Have there been any major changes to the Boostrix formula since its initial approval?

The core formula, including the active components and dosage, has remained consistent since its initial approval. However, the official indications for use, based on clinical data, have been expanded over time, such as expanding the approved age range and the specific indication for use during pregnancy.

Q: What is the typical timeframe for a minor side effect from Boostrix to resolve?

Official regulatory guidance generally describes common, mild-to-moderate side effects, such as injection site pain and low fever, as being temporary. These reactions are typically reported to last from one to three days.

Q: Is it necessary to wait a certain period after an injury before getting Boostrix?

For routine booster immunization, regulatory documents indicate that the Tdap vaccine can be administered regardless of the time since the last tetanus or diphtheria toxoid-containing vaccine. However, for use in wound management, the shot is considered necessary if five years or more have passed since the previous tetanus-containing vaccine.

Q: Does the manufacturer of Boostrix provide patient-friendly information?

Yes, manufacturers of licensed vaccines are officially required to provide information that assists in patient education, as regulated by government bodies. These materials include the official Vaccine Information Statement (VIS) and the Prescribing Information, which healthcare providers use to educate patients.

Q: What happens if I receive Boostrix too close to my last Td/Tdap shot?

In relation to short intervals for routine boosting, regulatory documents discuss the possibility of increased local reactions. Specifically, the regulatory label notes that a history of an Arthus-type hypersensitivity reaction to a previous tetanus shot requires a minimum ten-year interval before receiving Boostrix again.

Q: If I have a mild cold, can I still receive the Boostrix vaccine?

Official regulatory guidance indicates that vaccination should be deferred only for individuals who are experiencing an acute, severe febrile illness. A mild illness, such as a mild cold or low-grade fever, does not meet the criteria for deferral in official regulatory documents.

Q: What are the inactive ingredients in the Boostrix formulation?

According to the official product description, the inactive ingredients include sodium chloride, residual trace amounts of substances like formaldehyde and polysorbate 80 from the manufacturing process, and purified water. Additionally, aluminum salts are included to act as an adjuvant to help boost the immune response.

Q: Why does Boostrix only protect against three diseases?

Boostrix is specifically formulated and officially approved as a Tdap vaccine. It is designed to provide active immunity against the three diseases caused by the specific components it contains: Tetanus, Diphtheria, and Pertussis. The inclusion of additional components would classify it as a different combination vaccine.

Q: Has Boostrix been studied in people with chronic illnesses?

Official regulatory documents indicate that the initial clinical studies primarily involved healthy participants. The prescribing information notes that data regarding the effects of the vaccine on certain groups, such as those with specific chronic health conditions, are limited compared to the general population studied.

Q: What type of technology is used to create the Boostrix vaccine components?

The vaccine uses purified, detoxified bacterial toxins, known as toxoids, for the tetanus and diphtheria components. The pertussis components are purified, non-live acellular antigens—meaning they are parts of the Bordetella pertussis bacteria rather than the whole killed bacteria.

Q: What is the official definition of the three components in the Boostrix vaccine?

The components are purified, non-infectious proteins designed to trigger an immune response. The Tetanus Toxoid and Diphtheria Toxoid protect against the effects of toxins produced by those bacteria, while the Acellular Pertussis Antigens protect against the whooping cough bacterium.

How should Boostrix be stored and disposed of?

How to Store and Dispose of Boostrix

The storage and disposal of Boostrix (Tetanus, Diphtheria, and Pertussis Vaccine) must strictly follow official regulatory guidelines to maintain its stability.


Official Storage Conditions

Condition Requirement
Temperature Store refrigerated, between 2°C and 8°C (36°F and 46°F).
Freezing Do not freeze. The vaccine must be discarded if it has been frozen.
Light Store in the original container to protect it from light.
Safety Keep the vaccine out of the reach of children.

Handling and Disposal

Before use, the suspension must be shaken well to achieve a uniform, white turbidity; the product should be discarded if discoloration or particulate matter is present. Any unused or expired Boostrix and associated waste materials, such as the pre-filled syringe, must be disposed of in accordance with local requirements for pharmaceutical and sharps waste.

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

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