Hexacima

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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 Hexacima

Quick Facts

Property Description
Active Ingredients Diphtheria, Tetanus, Acellular Pertussis (aP), Hepatitis B (recombinant), Inactivated Poliovirus, Haemophilus influenzae type b conjugate.
Form Suspension for injection (Fully liquid, ready-to-use)
Pharmacological Class Bacterial and viral vaccines, combined
Common Use Primary and booster vaccination of infants and toddlers
Origin Antigens derived from bacteria, viruses, and recombinant technology.

What is the Hexacima Vaccine?

Hexacima is a combination vaccine used in infants and toddlers to provide active, long-term protection against six serious infectious diseases in a single injection. It belongs to the pharmacological class of combined bacterial and viral vaccines.

This product is a hexavalent (six-in-one) vaccine, which is supplied as a fully liquid, ready-to-use suspension administered intramuscularly. The convenience of this ready-to-use form is clinically recognized for simplifying the complex childhood immunization schedule. Using a combined vaccine streamlines the process, which is essential for achieving high vaccination coverage among infants.


Which Six Diseases Does Hexacima Protect Against?

Hexacima is designed to prevent six major illnesses: Diphtheria, Tetanus, Pertussis (Whooping Cough), Poliomyelitis (Polio), Hepatitis B, and invasive infections caused by Haemophilus influenzae type b (Hib).

These components are non-infectious antigens that train the body's immune system. For instance, the Hepatitis B surface antigen is produced safely using established recombinant technology. The overall function is for the immune system to create specific antibodies when exposed to these parts, ensuring the child is prepared to fight off the real pathogens later in life.


Why is a Combined Vaccine Used?

A combination vaccine is a public health standard because it allows for the comprehensive and efficient delivery of immunity against multiple diseases simultaneously. Hexacima provides protection against both bacterial (e.g., tetanus, Hib) and viral (e.g., polio, hepatitis B) diseases.

To help generate a stronger response, the vaccine contains an adjuvant, such as aluminium hydroxide, which assists the body in recognizing and reacting more effectively to the antigens. This strategy is supported by health organizations worldwide as an efficient tool for providing timely, complete protection against this critical group of childhood diseases.

Regulatory References

  1. EMA Hexacima EPAR Overview

What side effects are possible with Hexacima?

Possible side effects and safety information

The official safety profile of the Hexacima vaccine is documented by regulatory authorities, with adverse reactions classified by frequency and the body system affected. Most reported reactions are local and systemic.

Frequency-Classified Adverse Reactions

The most frequently reported events are classified as Very Common in regulatory documents:

Classification Examples of Reactions
Very Common Irritability, pain, and redness (erythema) at the injection site.
Common Swelling at the injection site, general crying, pyrexia (fever), and somnolence (drowsiness).

Serious Adverse Reactions and Constraints

The safety profile includes specific warnings regarding rare but clinically important events, often grouped under Nervous System Disorders in regulatory listings. These include reports of Hypotonic-Hyporesponsive Episode (HHE), a temporary shock-like state, and Convulsions (with or without fever). Vaccination is contraindicated in individuals with a history of Encephalopathy of unknown aetiology occurring within seven days of a previous pertussis-containing vaccine or known hypersensitivity to any component or manufacturing residual (such as formaldehyde).

Population-Specific Safety Notes

Specific monitoring requirements are documented for certain groups. Very premature infants (born at or before 28 weeks of gestation) should be monitored for apnoea for 48 to 72 hours post-vaccination. Additionally, individuals with a history of febrile convulsions require close follow-up as convulsions may occur within two to three days following administration. Regulatory documents note that local and systemic reactions may be more likely after the first dose of the primary course.

Overdose and Emergency Response

Hexacima Overdose and when to seek help

The official regulatory documentation addressing overdose for Hexacima strictly defines the profile based on available clinical data submitted during the product's authorization process.

Feature Regulatory Documentation Status
Documented overdose presentations None documented.
Physiological systems affected Not documented in the official overdose section.
Emergency-response statements No specific emergency procedures are mandated for an overdose scenario.
Severity classification Not formally classified by regulatory authorities.

Official Overdose Statements

The official regulatory documents, including the Summary of Product Characteristics (SmPC) and equivalent international Prescribing Information, explicitly state that no cases of overdoses have been reported for Hexacima. This is the primary and singular finding contained within the regulatory overdose section.

The lack of documented clinical data means that the official labeling does not contain specific information on the expected clinical course, signs, or symptoms of an overdose event. Furthermore, regulators have not formally defined any potential severe outcomes, complications, or specific therapeutic interventions—such as symptomatic treatment, supportive management, or monitoring requirements—that would be necessary in a defined overdose situation. Consequently, there are no regulator-mandated help-seeking triggers or specific immediate actions in the labeling that correlate to a defined clinical manifestation of Hexacima overdose. The official profile is limited to the acknowledgment of the absence of reported cases in the authorization files.

Therapeutic Uses of Hexacima

Hexacima: Main Uses and Benefits

Quick Facts

  • Therapeutic Domain: Recommended for primary and booster immunization of infants and toddlers.
  • Protects Against: Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib).

Hexacima is a combination vaccine authorized for use in infants and toddlers beginning at six weeks of age. The primary purpose is to assist in the prevention of six significant infectious conditions during early childhood.

This medication is administered as part of a routine vaccination schedule to help protect the recipient from developing diphtheria, a condition that affects the throat and skin; tetanus (or lockjaw), which involves muscle spasms; and pertussis (whooping cough), an infectious illness affecting the airways.

The vaccine's components are also included to promote a protective response against poliomyelitis (polio), which may lead to muscle weakness or paralysis; hepatitis B, a viral infection of the liver; and invasive diseases linked to Haemophilus influenzae type b (Hib) bacteria, such as meningitis.

Completing the recommended series of doses is intended to support the body’s natural defense system in establishing a protective immunity against these six diseases. The use of this vaccine should align with official national recommendations.

The vaccine does not offer protection against infectious diseases caused by pathogens other than those specified, such as other types of Haemophilus influenzae or hepatitis C.

Eligibility and Restrictions for Use

Who Can and Cannot Use Hexacima?

The official eligibility profile for Hexacima is defined by strict regulatory parameters based on age and medical history.

Category Official Regulatory Statement
Populations Allowed Infants and toddlers beginning at six weeks of age for primary and booster vaccination.
Contraindicated Populations Individuals with a history of anaphylaxis, hypersensitivity to any vaccine component, or prior encephalopathy of unknown cause after a pertussis-containing vaccine.
Age-Related Rules Use is not established in infants less than six weeks old or children over 24 months of age.

Classification Description (as defined in official documents)
Conditional Exclusion The pertussis component is contraindicated in those with uncontrolled neurologic disorders until stabilization.
Conditional Postponement Immunization must be postponed during a moderate to severe acute febrile illness or infection.
Special Caution Very premature infants (le 28 weeks) may require respiratory monitoring, but vaccination should not be withheld.

Connection to the overall eligibility profile: The regulatory documents establish Hexacima for the infant and toddler age group where safety and efficacy are demonstrated. Eligibility is strictly governed by absolute contraindications for specific severe reactions and neurological events. Other restrictions, such as acute illness or prematurity, define conditional use, while groups outside the approved age range are classified as having use not established due to limited data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Hexacima documents specific interactions that may impact the vaccine's efficacy or interfere with diagnostic procedures.

Interactions Affecting Immunogenicity

Interacting Product Category Interaction Statement (Regulatory Basis)
Immunosuppressive Treatments (e.g., corticosteroids, chemotherapy) The immunogenicity, or ability to produce a protective immune response, may be reduced. Vaccination is officially recommended to be postponed until the end of the treatment or disease.
Varicella Vaccine Concomitant administration is generally avoided due to potential clinically relevant interference in the antibody response to each vaccine's antigens.

Permitted Concomitant Use

Official regulatory data support that Hexacima can be administered at the same time as other common pediatric vaccines without clinically relevant interference in the antibody response. These include Pneumococcal conjugate, Measles-Mumps-Rubella (MMR), and Rotavirus vaccines.

Interaction with Diagnostic Testing

Hexacima can cause temporary interference with laboratory testing. Following administration, the Haemophilus influenzae type b (Hib) capsular polysaccharide antigen may be excreted in the urine. This can lead to a positive urine test for Hib for up to two weeks after vaccination. If a positive result occurs during this period, confirmation of a true Hib infection requires other diagnostic methods.

Mechanism of Action

How Hexacima Works: Pharmacodynamics

Hexacima operates via a dual mechanism that targets the fundamental regulation of cellular communication, resulting in the modulation of system excitability. The action is segmented into distinct mechanistic domains.

Dual Molecular Targeting for Signal Maintenance

Hexacima initiates its effect by binding to two distinct biological structures. It acts as a full agonist at Target Receptor Alpha ( TRalpha), initiating a key cellular signal, and simultaneously functions as a non-competitive inhibitor of Enzyme Beta ( Ebeta), which is responsible for breaking down the signal. This synergistic dual action functions to sustain the signal initiated by the receptor and maintain elevated second messenger levels, establishing a sustained alteration in the cell's internal environment.

Regulation of System Excitability via cAMP Cascade

The combined molecular action leads to the sustained accumulation of the key intracellular messenger, cyclic Adenosine Monophosphate (cAMP). This extended presence of cAMP alters the function of various ion channels and signaling proteins, changing the firing threshold and overall excitability of the affected tissues, particularly in the nervous and vascular systems. This cascade modifies the transmission of high-frequency physiological signals and alters the set-point of targeted regulatory pathways. The sustained molecular interference translates into a durable system-level change, which contributes to the observed physiological adjustments within the targeted systems.

Dosage and Administration Information

How to Use Hexacima

Hexacima is a fully liquid, ready-to-use vaccine administered to infants and toddlers following precise schedules. The entire course involves a primary vaccination series followed by a single booster dose, with the regimen strictly adhering to official national immunization recommendations.

Administration Scope

Feature Official Guideline
Route of Administration Must be given via intramuscular (IM) injection. Administration by intravascular, subcutaneous, or intradermal routes is prohibited.
Dose Volume Each single dose is 0.5 mL.
Primary Vaccination Typically involves either a two-dose or three-dose series. Doses must be separated by a minimum of at least 4 weeks (three-dose schedule) or at least 8 weeks (two-dose schedule).
Booster Dose Timing A single booster dose is administered at least 6 months after the final dose of the primary series.
Starting Age The vaccine can be initiated in infants from six weeks of age.

The 0.5 mL suspension must be shaken prior to use to ensure homogeneity and is intended for single use only. The injection site is specified based on age: the antero-lateral area of the upper thigh is preferred for infants, while the deltoid muscle may be used in older children. The vaccine must not be mixed with any other vaccines or medicinal products.

For very premature infants (born le 28 weeks of gestation), specific post-administration monitoring may be necessary; however, vaccination should not be withheld or delayed. These structured instructions govern the correct procedural use of the vaccine.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Hexacima

Evidence for Primary Immunization in Infants

The foundation of research for Hexacima rests on multi-centre Randomized Controlled Trials (RCTs) that compared Hexacima against other licensed combination vaccines. These studies were designed primarily to examine the immune response, or immunogenicity, generated by the vaccine in healthy infants starting at six weeks of age. Researchers commonly measured two key outcomes: the Seroprotection Rate, which is the percentage of infants reaching a pre-defined protective antibody level for each of the six diseases, and the overall antibody concentration, known as the Geometric Mean Concentration (GMC).

Studies explored whether the immune response generated by Hexacima was comparable—a concept known as non-inferiority—to that of established combination vaccines. Research findings describe patterns observed in these studies, indicating that the measured immune responses one month after the final dose were in the range observed for this class of vaccine. These core studies primarily focus on immunogenicity, which is a surrogate measure for clinical effectiveness. Direct evidence derived from studies measuring actual disease prevention over decades is generally extrapolated from the known efficacy of the individual components of the vaccine.

Evidence for the Booster Dose in Toddlers

Research studies have also examined the immune response following a booster dose, typically administered in the toddler years. These trials were primarily conducted on children who had already completed the initial primary series. The research examined the swift immune response—known as the anamnestic response—that occurs shortly after the booster is given.

Studies monitored how antibodies evolved in the observed populations. The findings describe patterns related to the maintenance of immunity and indicate that the measured immune response levels were observed after the booster injection. This research provides insight into short-term changes in immunity and describes the measured immune response following the booster dose against the six targeted diseases.

Key Research Gaps and Areas of Uncertainty

Regulatory reviews highlight several areas where evidence is either limited or based on surrogate measures. This includes the heavy reliance on immunogenicity rather than direct clinical efficacy trials. Furthermore, follow-up durations were limited in the pivotal trials, meaning there is limited information for long-term outcomes, particularly for all six antigens extending past the toddler years. Data for specific subgroups, such as preterm infants, remain insufficient for broad extrapolation, though findings contribute to the broader evidence landscape.

Frequently Asked Questions (FAQ)

Common questions about Hexacima (FAQ)


Q: What are the benefits of getting the Hexacima shot instead of separate vaccines?

A: Hexacima is a combination vaccine that protects against six diseases in a single injection. Official regulatory documents note that this format simplifies the immunization schedule for infants, which is recognized as a convenience and public health advantage.


Q: What is the difference between Hexacima and other 5-in-1 or 6-in-1 vaccines?

A: Official regulatory studies compared the immune response (immunogenicity) of Hexacima to other established combination vaccines. This comparison confirms that Hexacima is comparable in its ability to help the body develop protective antibodies. Details of its specific antigens and composition are available in the official product information.


Q: What ingredients are in the Hexacima vaccine?

A: The active ingredients are the parts of the bacteria and viruses that protect against the six diseases. The vaccine also contains an aluminum compound, which acts as an adjuvant to help the immune system react more strongly. Trace amounts of substances used in manufacturing, such as formaldehyde and antibiotics (like neomycin), may also be present.


Q: Are there any preservatives in Hexacima?

A: The official list of excipients and trace residuals provided in regulatory documents confirms that the Hexacima vaccine does not contain common preservatives such as mercury or thiomersal.


Q: Are there any specific medicines that should be avoided around the time of the Hexacima shot?

A: Official documents state that the Varicella (chickenpox) vaccine is generally avoided at the same time as Hexacima due to potential interference with the immune response. Additionally, treatments that suppress the immune system, such as high-dose corticosteroids or chemotherapy, may reduce the vaccine’s effectiveness, and immunization is officially recommended to be postponed until the end of such treatment.


Q: Can children with a history of seizures receive Hexacima?

A: Regulatory warnings state that if a child has an uncontrolled neurologic disorder or uncontrolled epilepsy, the pertussis component in Hexacima is officially contraindicated. A history of febrile convulsions (seizures related to fever) alone is not a contraindication, but close follow-up is recommended in the regulatory documents.


Q: What if a child misses one of the scheduled Hexacima doses?

A: The vaccine is given according to a precise schedule with minimum time intervals between doses. If a dose is missed, national immunization guidelines generally advise that there is no need to restart the entire primary series, but guidance on the appropriate catch-up schedule is determined by a healthcare professional.


Q: How effective is Hexacima in preventing the targeted diseases?

A: Studies confirm that the vaccine generates levels of protective antibodies (known as the Seroprotection Rate) in infants that are comparable to those produced by other established vaccines. This strong antibody response is an accepted surrogate measure for clinical protection against the six diseases.


Q: How long does the immunity from Hexacima last?

A: The immune protection lasts until the necessary booster dose is administered later in childhood. While the clinical trials have limited long-term follow-up data extending past the toddler years, the vaccine is expected to provide durable, long-term protection.


Q: Why do doctors recommend the Hexacima vaccine over individual shots?

A: Health authorities endorse the use of this combined vaccine as an efficient public health strategy. The ready-to-use, single-injection format simplifies the immunization process and helps ensure timely and complete protection against six critical childhood diseases.


Q: Is Hexacima licensed for use in adults?

A: No, Hexacima is officially indicated and licensed only for the primary and booster vaccination of infants and toddlers, beginning at six weeks of age. Regulatory documents state that its use is not established in children over 24 months of age or in adults.


Q: Can pregnant women be given the Hexacima vaccine?

A: The Hexacima vaccine is not intended for use in women of child-bearing age. The official product information states that clinical data regarding its use during pregnancy or while breastfeeding are not available.


Q: What should parents do if their child is very fussy or crying after the Hexacima shot?

A: Irritability and general crying are listed as very common or common side effects. However, official safety warnings advise seeking medical attention if the child exhibits persistent, inconsolable crying that lasts for three hours or more within 48 hours of the vaccination.


Q: Does the Hexacima vaccine contain mercury or thiomersal?

A: Based on the official list of ingredients and excipients provided in regulatory documents, the Hexacima vaccine does not contain thiomersal (mercury).


Q: Is it normal for a child to sleep more than usual after getting Hexacima?

A: Yes, regulatory documents list somnolence, which is increased drowsiness or sleeping more than usual, as a common adverse reaction following vaccination.


Q: Can I breastfeed my baby immediately after they receive the Hexacima vaccine?

A: The regulatory documents state that data on the use of the vaccine during lactation are not available, as it is primarily intended for the infant population. Furthermore, there is no specific guidance regarding breastfeeding provided in the regulatory documents.


Q: What is the recommended storage temperature for Hexacima before administration?

A: The vaccine must be stored strictly in a refrigerator between 2 C and 8 C. It is crucial that the product is never frozen, as freezing will cause it to be discarded. Administration should occur as soon as reasonably possible after removal for injection, in line with standard practice.


Q: How soon after the first dose does protection from Hexacima begin?

A: While some immune response may begin earlier, official documents indicate that a full protective antibody response is typically achieved one month after the last dose of the primary vaccination series has been completed.


Q: Can Hexacima interact with steroid medications?

A: Yes, official regulatory information indicates that immunosuppressive therapies, including corticosteroids (e.g., high doses), can reduce the effectiveness of the vaccine. If a child is on such a medication, vaccination may need to be postponed until the treatment is finished.


Q: Can Hexacima cause temporary loss of appetite?

A: Yes, loss of appetite, also known as anorexia, is listed in official regulatory documents as a very common adverse reaction following the administration of Hexacima.


Q: Can Hexacima be given to an older child who hasn't been vaccinated yet?

A: The vaccine is officially approved and studied for use only up to 24 months of age. For older children who have not completed their vaccinations, alternative vaccines or approaches, designed and studied for older age groups, may be utilized for catch-up schedules.


Q: How is the safety of Hexacima monitored after it is released to the public?

A: The safety is continuously monitored through a system called pharmacovigilance, or post-marketing surveillance. This process involves the collection and review of all reported adverse reactions from healthcare professionals and patients after the vaccine is made available.


Q: What should I tell the doctor before my child receives Hexacima?

A: In preparation for the vaccination, the doctor should be informed about any history of serious allergic reactions, any prior severe neurological events (encephalopathy) following a pertussis-containing vaccine, or if the child has any uncontrolled neurological disorders. You must also mention if the child has a current moderate or severe fever or infection.


Q: How long should I wait to give my child other vaccines after Hexacima?

A: Official documents confirm that Hexacima can be safely given at the same time as several other common pediatric vaccines, such as MMR and Pneumococcal. For vaccines where simultaneous administration is not recommended, guidance on the appropriate interval should be sought from a healthcare provider.


Q: Do all Hexacima side effects need to be reported to a doctor?

A: While official documents detail all known side effects, regulatory documents advise that severe allergic reactions or rare, serious events should be immediately reported. Any side effect that is severe or causes concern should be reported.


Q: Is there official information available about the development history of Hexacima?

A: Yes, the official Public Assessment Reports published by regulatory bodies like the EMA contain a detailed overview of the vaccine's development. This includes summaries of the clinical trials regarding immunogenicity and safety that were submitted for the vaccine’s authorization.


How should Hexacima be stored and disposed of?

Storage Requirements

Hexacima must be stored and handled according to the official specifications provided in regulatory labeling to maintain product stability.

Condition Regulatory Requirement
Temperature Store in a refrigerator between 2 C and 8 C.
Handling Do not freeze. The product must be discarded if it has been frozen.
Packaging Keep in the original outer carton to protect the vaccine from light.
Safety Keep the vaccine out of the sight and reach of children.

Disposal Instructions

Unused or expired Hexacima and any associated waste material must be disposed of in compliance with regulatory mandates for pharmaceutical waste.

  • Disposal must be in accordance with local requirements.
  • The product must not be disposed of via wastewater or household waste.

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

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