Infanrix Tetra

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Infanrix Tetra

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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 Infanrix Tetra

This overview section defines the core nature, composition, and general purpose of the Infanrix Tetra product, highlighting its unique role in pediatric immunization.

Property Description
Active ingredient Diphtheria toxoid, Tetanus toxoid, Pertussis antigens, Inactivated Poliovirus antigens
Form Suspension for injection (Prefilled syringe)
Pharmacological class Combination Vaccine, Immunological Agent
Common use Active immunization against Diphtheria, Tetanus, Pertussis, Poliomyelitis
Origin Biological product (Manufactured by GlaxoSmithKline Biologicals)

What Is Infanrix Tetra and Its Classification?

Infanrix Tetra is a prescription-only Immunological Agent classified as a Quadrivalent Combination Vaccine, specifically designed for the pediatric population. The product is presented as a sterile, noninfectious Suspension for injection typically provided in a prefilled syringe. This quadrivalent formulation ensures simultaneous active immunity against diphtheria, tetanus, pertussis, and poliomyelitis. This combined approach is clinically recognized for streamlining national vaccination programs and maximizing the efficient use of scheduled visits in early childhood. The vaccine is manufactured by GlaxoSmithKline Biologicals.


The Composition of Infanrix Tetra: Acellular and Inactivated Antigens

The preparation is an Inactivated vaccine and a Biological product composed of active agents derived from non-living, non-pathogenic materials. Its active ingredients include chemically modified bacterial toxins, or Toxoids (Diphtheria toxoid and Tetanus toxoid), and purified surface proteins from the Bordetella pertussis bacterium, alongside Inactivated Poliovirus Antigens. These components are suspended in an Aqueous suspension containing aluminum salts, which serve as adjuvants to enhance the resulting immune response. Pharmacological studies confirm that the vaccine’s acellular pertussis component, which uses purified antigens, supports strong immunogenicity while maintaining a favorable profile for young children.


General Purpose: Prevention and Active Immunity

The primary purpose of Infanrix Tetra is strictly prophylactic, aiming to prevent the development of the four target diseases rather than providing treatment for an existing infection. By introducing these specific, non-pathogenic antigens into the body, the vaccine initiates Immunity induction, training the immune system to generate protective antibodies. This process prepares the body’s natural defenses to recognize and neutralize the actual pathogens, thus providing targeted, long-term active immunization against diphtheria, tetanus, whooping cough, and poliomyelitis.

What side effects are possible with Infanrix Tetra?

Possible Side Effects and Safety Information

The safety profile of Infanrix Tetra is established through clinical studies and post-marketing surveillance, with adverse reactions formally categorized by government regulatory agencies based on frequency and affected system-organ classes.

Frequency Classification of Adverse Reactions

The majority of documented effects are typically observed within the first 48 hours following vaccination, with reactions often classified as Very Common or Common in official labeling.

Classification Examples of Reactions
Very Common (ge 10%) Pain, redness, and swelling at the injection site; fever; irritability; somnolence; loss of appetite.
Common (ge 1% - <10%) Restlessness; gastrointestinal issues (diarrhoea, vomiting).
Uncommon (ge 0.1% - <1%) Persistent crying (ge 3 hours); induration (hardening) at the injection site; fatigue; headache.

Serious Adverse Reactions and Safety Constraints

Official documents list rare but clinically significant adverse events, primarily based on post-marketing data. These include anaphylactic reaction, seizures (convulsions), and the hypotonic-hyporesponsive episode (collapse or shock-like state) reported to occur within 48 hours.

Specific safety constraints are documented. The vaccine is contraindicated in individuals with a history of encephalopathy (brain disease) of unknown cause occurring within seven days after a previous pertussis-containing vaccination. Caution is also noted for very premature infants (le 28 weeks gestation) regarding the potential risk of apnoea (temporary cessation of breathing), requiring appropriate monitoring. Local reactogenicity and fever may be reported with greater frequency following a booster dose compared to the primary series.

Overdose and Emergency Response

Infanrix Tetra Overdose and when to seek help

The official regulatory documents for Infanrix Tetra, a quadrivalent combination vaccine, indicate that a distinct, toxicological overdose syndrome is not defined. Regulatory reports state that no cases of overdose have been formally documented in the official prescribing information.


Overdose Manifestations and Required Actions

Feature Official Regulatory Statement
Documented Manifestations No case of overdose has been reported. Clinical effects of accidental over-dosage are expected to be similar to the adverse events seen following a standard dose administration of the vaccine, rather than a unique toxic event.
Management Strategy Treatment should be symptomatic and supportive. No specific antidote is known or documented in the regulatory labeling for over-administration.
Required Emergency Action Seek immediate medical attention for any suspected administration error or the occurrence of an unexpectedly severe reaction. Appropriate medical resources, including agents for managing acute hypersensitivity, must be immediately available.
Regulatory Constraint The official profile does not define a toxic dose level nor are there population-specific factors documented regarding the severity of an overdose.

Regulatory Profile Summary

The official regulatory profile is structured around the finding that a specific overdose syndrome has not been established. This necessitates that emergency-seeking conditions are driven by the severity of generalized acute reactions observed following the error, and that management must rely entirely on symptomatic and supportive measures. Immediate medical help is required for any severe or unexpected symptom following the over-administration event.

Therapeutic Uses of Infanrix Tetra

The primary utility of Infanrix Tetra is centered on establishing active, long-term immunity in the pediatric population. The therapeutic benefit is the prevention of four distinct, severe infectious conditions: Diphtheria, Tetanus, Pertussis, and Poliomyelitis.


Prevention of Severe Neuromuscular Dysfunction and Respiratory Distress

This therapeutic domain is relevant in contexts marked by increased discomfort and symptoms of heightened neurological or muscular activity. The vaccine is relevant for easing the potential burden of painful, sustained muscle spasms (lockjaw) associated with Tetanus, the severe symptoms related to systemic imbalance of Diphtheria, and the disruptive paroxysmal coughing episodes of Pertussis. The prophylactic application assists with maintaining a sense of stability against the risks of these severe childhood infections.

Foundational Protection in Routine Programs

Infanrix Tetra is relevant in therapeutic domains involving the prevention of four major infectious diseases. It is commonly used in clinical settings that involve acute or unstable symptom patterns, such as those associated with the potential for physical impairment and loss of functional stability related to Polio. The vaccine contributes to the overall symptom load reduction by providing comprehensive, foundational protection during early childhood.

Protection against these four major disease threats provides necessary support against the most debilitating childhood risks.


Quick Fact: Protection against Four Major Disease Threats The vaccine is commonly used in clinical settings that involve acute or unstable symptom patterns, helping address symptom clusters related to severe systemic imbalance and physical discomfort.

Regulatory References

  1. US FDA prescribing information for a DTaP vaccine

Eligibility and Restrictions for Use

Infanrix Tetra is officially approved for use in the pediatric population, specifically for infants and children up to the age of seven years (prior to the seventh birthday).

Contraindicated (Must Not Use) Populations

Official regulatory documents stipulate that the vaccine is contraindicated for individuals in the following situations:

  • Severe Allergic Reactions: A known hypersensitivity (severe allergic reaction or anaphylaxis) to any component of the vaccine or to a previous dose of any vaccine containing diphtheria, tetanus, or pertussis antigens.
  • Prior Encephalopathy: Having experienced encephalopathy (a disease of the brain) of unknown cause within seven days following previous vaccination with any pertussis-containing vaccine. In such a circumstance, pertussis vaccination must be discontinued, and the remaining schedule should be continued with a vaccine excluding the pertussis component.
  • Progressive Neurologic Disorder: An existing, progressive or unstable neurologic disorder, such as uncontrolled epilepsy or progressive encephalopathy.

Restricted or Special Consideration

Administration should typically be postponed in the presence of an acute, severe febrile illness. The vaccine may be administered, however, in the presence of a minor infection, such as a mild cold.

What should I know about interactions with other medicines?

Infanrix Tetra Interactions with other medicines and products

Official regulatory information for the Infanrix Tetra vaccine focuses on interactions that affect the body's immune response and specific co-administration rules. As an immunological agent, this product is not associated with the common metabolic or transporter-mediated drug interactions (such as CYP enzyme effects) seen with small-molecule drugs.

Immunological and Pharmacodynamic Interactions

Interaction Type Interacting Agents (Class) Official Regulatory Finding
Reduced Efficacy Immunosuppressive Therapies (e.g., corticosteroids, chemotherapy) May result in a sub-optimal or reduced protective immune response.
Additive Reactogenicity Other Concomitant Vaccines (e.g., Pneumococcal Conjugate) Officially associated with an increased incidence of febrile reactions (fever) compared to administering the vaccine alone.
Population Note Immunodeficient Individuals The risk of reduced efficacy is specifically noted as heightened in this population.

Procedural and Timing Restrictions

Contraindicated Combinations and Restrictions:

  • The vaccine must not be mixed in the same syringe with any other vaccine or substance, as this is an explicit regulatory prohibition.
  • Official labeling may advise against the use of the vaccine following a history of encephalopathy of unknown cause occurring within seven days of a previous pertussis-containing vaccine.

Timing Requirements:

  • If an individual is scheduled to begin intensive immunosuppressive therapy, the vaccination series should be completed at least two weeks prior to the start of the therapy.
  • If the vaccine was administered during active immunosuppression, official guidelines may recommend revaccination at least three months after the cessation of the therapy.

Food and Alcohol:

  • There are no known interactions documented in the regulatory labeling between Infanrix Tetra and the ingestion of food or drinks. The status of interaction with alcohol is not officially documented.

Mechanism of Action

Infanrix Tetra is a quadrivalent combination biological agent composed of four distinct immunogenic components adsorbed onto an aluminum salt adjuvant.

Biological Targets and Signaling

Following intramuscular administration, the aluminum adjuvant is taken up by antigen-presenting cells (APCs) at the injection site. This internalization triggers the activation of pattern recognition receptors (PRRs), leading to a downstream signaling cascade that results in the local production of chemokines and cytokines.

Molecular and Cellular Interaction

The four active components—inactivated diphtheria toxoid, inactivated tetanus toxoid, acellular pertussis antigens (detoxified pertussis toxin, filamentous hemagglutinin, and pertactin), and inactivated poliovirus (types 1, 2, and 3)—are recognized as non-self antigens by dendritic cells and macrophages, which process and present them to T-lymphocytes (T cells).

Downstream Cascades and System-Level Consequences

This presentation initiates T-cell activation and clonal expansion, supporting the differentiation of B-lymphocytes (B cells) into plasma cells. The plasma cells function as molecular factories, synthesizing and secreting large quantities of antigen-specific immunoglobulin G (IgG) antibodies directed against the bacterial toxoids, pertussis surface antigens, and the viral capsid proteins. Additionally, the process establishes long-lived memory B and T cells. The subsequent systemic circulation of these specific antibodies and the existence of memory cells provide a modulated capacity for accelerated and intensified secondary immune responses upon subsequent exposure to the respective native antigens.

Dosage and Administration Information

How to Use Infanrix Tetra

The usage of Infanrix Tetra is strictly defined by regulatory guidelines as a standardized, multi-dose regimen administered to the pediatric population. The product is a sterile, ready-to-use suspension for injection, and its administration is independent of meal consumption.


Official Administration Guidelines

Feature Procedural Instruction
Route of Administration The vaccine must be given only as a 0.5 mL Intramuscular (IM) injection. Administration via any other route, such as intravenously, is strictly prohibited.
Preparation Immediately before use, the prefilled syringe must be shaken vigorously until the suspension appears uniform and turbid white. The product requires visual inspection to ensure no particulate matter is present.
Dose Volume A fixed volume of 0.5 mL constitutes one single dose across the entire course.
Injection Site The preferred site for infants is the anterolateral aspect of the thigh. In older children, the deltoid muscle of the upper arm is typically utilized.

Official Dosing Schedule

The complete use protocol involves a sequential, multi-dose series that typically begins in infancy. The schedule generally consists of a primary course of three doses, with intervals between doses of approximately one to two months, followed by subsequent booster doses administered during the toddler and early childhood years. If the primary series is interrupted, the course should not be restarted, and the remaining doses should be given as soon as possible to complete the regimen. The entire administration procedure forms a critical component of national immunization programs aimed at providing long-term active immunity.

Recent Clinical Evidence

Infanrix Tetra is a quadrivalent combination vaccine covering Diphtheria, Tetanus, acellular Pertussis (DTaP), and Inactivated Poliovirus (IPV). Clinical research focuses primarily on demonstrating robust immunogenicity and a predictable safety profile when administered as a primary series and booster doses in infants and young children.

Immunogenicity and Efficacy Studies

Studies evaluate the vaccine’s ability to induce protective levels of antibodies against each component. Seroprotection rates—the percentage of participants achieving a specified threshold of antibodies—are the primary measure used in clinical trials. Key findings from research include:

  • Diphtheria and Tetanus: High seroprotection rates (typically approaching 100%) against diphtheria and tetanus toxoids have been consistently observed across various clinical settings following the primary vaccination series.
  • Pertussis: Efficacy against pertussis disease is primarily demonstrated through research on the DTaP component, which may show protective effects sustained for several years after the final dose in childhood, though protection may wane over time.
  • Poliovirus: Seroprotection against Poliovirus Types 1, 2, and 3 is generally high after the completed primary course, indicating a strong immune response to the inactivated poliovirus components.

Safety Profile Overview

Clinical trials monitor the occurrence and severity of solicited (expected) and unsolicited adverse events. The overall safety profile evaluated in studies is generally consistent across different combined DTaP-IPV formulations.

Common Solicited Events (Observed in Trials) Description
Local Reactions Pain, redness, or swelling at the injection site.
Systemic Reactions Fever, irritability, drowsiness, and loss of appetite.

Most reported adverse events in clinical trials are mild-to-moderate and self-limiting, typically resolving within one to three days. Research continues to support the use of combination vaccines to help reduce the number of injections required for routine childhood immunization schedules.

Key Studies & References

  1. Summary of Product Characteristics (SmPC) - IPV Infanrix (Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine)
  2. Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine (NCT01086423)

Frequently Asked Questions (FAQ)

Common questions about Infanrix Tetra (FAQ)


Q: Does Infanrix Tetra contain mercury or thiomersal?

According to the official product information, Infanrix Tetra is manufactured without thiomersal, which is a mercury-containing compound. Therefore, the vaccine does not contain thiomersal.


Q: Why is this vaccine given in a series of shots?

Regulatory sources recommend a multi-dose series because a single dose is generally insufficient to produce a sustained immune response. The series is designed to help the body establish protective immunologic memory, which is essential for protection against the four target diseases.


Q: Are there any common over-the-counter pain relievers that interact with Infanrix Tetra?

Regulatory information indicates that Infanrix Tetra is not associated with the common type of drug interactions seen with small-molecule medications. Studies have examined the co-administration of antipyretics (fever-reducing medicines) at the time of vaccination. Any guidance regarding the use of pain relievers around the time of vaccination would come from a healthcare provider based on individual patient circumstances.


Q: Is it necessary to avoid certain foods after receiving Infanrix Tetra?

Official regulatory labeling explicitly states that there are no known interactions documented between Infanrix Tetra and the ingestion of food or drinks. Therefore, no specific dietary restrictions are noted following the administration of the vaccine.


Q: What is the recommended age range for receiving Infanrix Tetra?

Official information indicates the vaccine is approved for administration in the pediatric population. The series typically begins in infancy, starting from approximately 6 weeks of age, and is generally completed before the child's seventh birthday.


Q: Can an adult receive Infanrix Tetra?

Official documents state that Infanrix Tetra is specifically indicated and approved for use in the pediatric population (infants and children), generally up to seven years of age. It is not indicated for administration to adults.


Q: What is the typical time frame between doses of Infanrix Tetra?

The primary immunization course typically consists of three doses. Regulatory documents generally specify intervals between these doses of approximately four to eight weeks (one to two months). The exact timing will be based on the local or national immunization schedule being followed.


Q: What happens if a dose of Infanrix Tetra is missed or delayed?

Official guidelines recommend that the immunization course should not be restarted if a dose is missed or delayed. Instead, the remaining doses should be given as soon as possible. This supports the goal of achieving protection without restarting the entire initial vaccination course.


Q: Can Infanrix Tetra be given at the same time as other vaccines?

Yes, regulatory and public health guidelines often permit Infanrix Tetra to be administered concurrently with other routine childhood vaccines. When this is done, the vaccines must be given at separate injection sites, preferably in a different limb.


Q: How long do common side effects from Infanrix Tetra usually last?

Official product information indicates that most common side effects, such as fever or injection site reactions, are self-limiting. They are typically observed within the first 48 hours following vaccination and generally resolve within one to three days.


Q: What does a severe allergic reaction (anaphylaxis) to this vaccine look like?

While rare, official warnings note that a severe allergic reaction (anaphylaxis) appears suddenly and is a medical emergency. Signs can include difficulty breathing, generalized rash (hives), swelling of the face, lips, or tongue, and a drop in blood pressure.


Q: Is Infanrix Tetra recommended for people with a history of seizures?

Regulatory information indicates that administering the vaccine warrants careful consideration if a child has a history of seizures that occurred shortly after a previous pertussis-containing vaccine. For children with progressive or unstable neurologic disorders, guidelines often recommend deferring vaccination until the condition is stable.


Q: Does having a mild cold mean the shot should be postponed?

Regulatory documentation specifies that the presence of a minor infection, such as a mild cold or a low-grade fever, is generally not considered a reason to postpone the vaccination. Administration should only be deferred in the presence of an acute, severe illness with a high fever.


Q: How effective is Infanrix Tetra against Pertussis (whooping cough)?

Clinical research focuses on the ability of the acellular pertussis component to induce a protective immune response. Studies demonstrate a strong seroprotection rate—the level of antibodies achieved—after the primary series, indicating the development of a strong immune response against the disease.


Q: What is the duration of protection offered by Infanrix Tetra?

Official guidance notes that the strength of the protective immune response, particularly against pertussis, may decrease over time following the primary series and booster doses. Periodic booster doses are necessary to help maintain long-term protective immunity against the targeted diseases.


Q: What is the role of the aluminum component (adjuvant) in Infanrix Tetra?

The aluminum salt component included in the vaccine acts as an adjuvant. Regulatory labeling explains that the purpose of the adjuvant is to help enhance the body's overall immune response to the vaccine's active ingredients.


Q: What are the known interactions between Infanrix Tetra and blood thinners?

Official safety information notes caution regarding administration in individuals with a bleeding disorder or thrombocytopenia (low platelet count). This is noted as a standard caution for individuals with bleeding risks, such as those using blood thinners, due to the nature of an intramuscular injection.


Q: Has Infanrix Tetra been studied in premature infants?

Regulatory documents include specific warnings regarding administration to very premature infants (those born at or before 28 weeks gestation). Official information states that a risk of apnoea (temporary cessation of breathing) should be considered, and monitoring may be required for these infants for 48 to 72 hours after vaccination.


Q: Are there any warnings about fainting or syncope related to receiving the shot?

Yes, official labeling includes a warning that syncope, or fainting, can occur in association with the administration of injectable vaccines. This is a recognized reaction often observed with needle procedures in general.


Q: Is Infanrix Tetra available globally under different names?

Official public health sources acknowledge that similar DTaP-IPV products (containing Diphtheria, Tetanus, acellular Pertussis, and Inactivated Poliovirus) are used globally, though the specific brand name may vary depending on the country or manufacturer.


Q: Why is it important to report unexpected reactions to the vaccine?

Regulatory bodies require the reporting of adverse events following immunization (AEFI) as part of post-marketing surveillance. This continuous monitoring is essential for verifying the vaccine's safety profile and identifying rare events once the product is in widespread use.


Q: Is the schedule for Infanrix Tetra the same in all countries?

Official documents often state that local or national immunization schedule recommendations must be followed. This indicates that the timing, number, and intervals of doses may vary slightly between different countries or regions, as determined by local public health policy.


Q: How is the stability and efficacy of the vaccine maintained during transport?

Official storage guidelines mandate strict temperature control between 2 C and 8 C. This temperature range must be maintained during transport and storage, and freezing the vaccine is strictly prohibited, as temperature extremes compromise its stability and efficacy.


Q: Is there a maximum age limit specified in the official documents for receiving the final dose?

Infanrix Tetra is typically approved for the pediatric population, and the final doses are generally administered before the child's seventh birthday. However, official catch-up or regional guidelines may specify use up to a slightly older age to ensure the series is completed.


Q: Is the protection offered by Infanrix Tetra for Tetanus permanent?

Protection from the tetanus component, while highly effective, is not permanent. Regulatory guidance and general immunization principles indicate that protection wanes over time, necessitating periodic booster doses to help maintain protective antibody levels.


Q: What is the difference between the 'a' and 'P' in DTaP component of the vaccine?

The 'aP' stands for acellular pertussis. The 'acellular' classification means the vaccine contains purified, non-infectious proteins (antigens) from the Bordetella pertussis bacterium, rather than the entire inactivated cell. This design is intended to elicit a strong immune response.


Q: Can a child who had whooping cough still receive Infanrix Tetra?

Official immunization principles note that having the natural infection may not confer permanent immunity. Therefore, official guidelines often indicate that children who have recovered from whooping cough (pertussis) are still advised to complete the DTaP-IPV vaccination series as scheduled.


Q: Does Infanrix Tetra contain antibiotics or preservatives?

Official documents list the vaccine's specific excipients. Trace amounts of antibiotics, such as neomycin and polymyxin, may be present in the final vaccine due to their use during the manufacturing process.

How should Infanrix Tetra be stored and disposed of?

Storage and Handling Requirements

Infanrix Tetra must be stored under refrigerated conditions, with the temperature strictly maintained between 2 C and 8 C ( 36 F and 46 F). The product is highly sensitive to temperature extremes; therefore, it is prohibited to freeze the vaccine. If the vaccine has been frozen, it must be discarded immediately, as freezing compromises its stability and renders it unusable.

To ensure proper protection, the vaccine must be stored in its original outer carton to shield the contents from light exposure. As with all medications, the product must be kept out of the sight and reach of children.

Disposal Instructions

Disposal of unused, expired, or compromised Infanrix Tetra must follow official local requirements for medicinal product waste. Used needles and syringes are classified as sharps and must be placed in a dedicated, puncture-proof sharps disposal container, complying with all state and federal regulations for safe handling.

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

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