Medical Editor: John P. Cunha, DO, FACOEP
Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine) is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenza type b. Vaxelis is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). Common side effects of Vaxelis include:
- injection site reactions (pain, redness, swelling),
- decreased appetite,
- fever, and
The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. Vaxelis may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and vaccines you recently received. Vaxelis is not approved for use in individuals 5 years of age and older and is not intended for use in pregnant or breastfeeding women.
Our Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine) Suspension for Intramuscular Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Rates of adverse reactions varied by number of doses of VAXELIS received. The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
Clinical Trials Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
The safety of VAXELIS was evaluated in 6 clinical studies, in which a total of 5,251 infants 43 to 99 days of age at enrollment received at least 1 dose of VAXELIS. Two of these (study 005 and 006) were controlled clinical studies conducted in the US, in which a total of 3,380 infants 46 to 89 days of age at enrollment received at least 1 dose of VAXELIS. The vaccination schedules of VAXELIS, Control vaccines, and concomitantly-administered vaccines used in these studies are provided in Table 1. At 15 months of age, participants in Study 005 received a dose of DAPTACEL and a H. influenzae type b conjugate vaccine, whereas participants in Study 006 received a dose of Pentacel. In a non-US study, 294 children received a dose of VAXELIS at 15 months of age.
Across the 2 studies conducted in the US, among all randomized participants (3,392 in the VAXELIS group and 889 in the Control group), 52.6% were male and 47.4% were female. The race distribution was as follows: 71.7% were White, 11.0% were Black, 4.5% were American Indian or Alaska Native, 3.5% were Asian, and 9.3% were of other racial groups. Most participants (81.8%) were of non-Hispanic or Latino ethnicity. The racial/ethnic distribution of participants who received VAXELIS and Control vaccines was similar.
Table 1: Clinical Safety Studies with VAXELIS in the
US: Vaccination Schedules
|Study||Vaccine||Concomitantly Administered Vaccines|
|005*||VAXELIS at 2, 4, 6 months and DAPTACEL + PedvaxHIB® at 15 months||RotaTeq® at 2, 4, and 6 months Prevnar 13® at 2, 4, 6, and 15 months|
|Control group vaccines: Pentacel at 2, 4, 6 months and RECOMBIVAX HB® at 2 and 6 months DAPTACEL+ ActHIB® at 15 months||RotaTeq at 2, 4, and 6 months Prevnar 13 at 2, 4, 6, and 15 months|
|006*||VAXELIS at 2, 4, 6 months and Pentacel at 15 months||RotaTeq at 2, 4, and 6 months Prevnar 13 at 2, 4, 6, and 15 months|
|Control group vaccines: Pentacel at 2, 4, 6, and 15 months RECOMBIVAX HB at 2 and 6 months||RotaTeq at 2, 4, and 6 months Prevnar 13 at 2, 4, 6, and 15 months|
|* The first dose of Hepatitis B vaccine was administered
prior to study initiation (prior to or at 1 month of age).
Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
RECOMBIVAX HB (Hepatitis B Vaccine [Recombinant])
Solicited Adverse Reactions
Information on solicited adverse events was recorded daily by parents or guardians on vaccination report cards. The incidence and severity of solicited injection site and systemic adverse reactions (i.e., vaccine-related adverse events) that occurred within 5 days following each dose of VAXELIS or Control vaccines at 2, 4, and 6 months of age in studies 005 and 006 are shown in Table 2.
Table 2: Percentage of Infants with Solicited Adverse
Reactions Occurring within 5 days Following VAXELIS or Control Vaccines
Administered Concomitantly at Separate Sites with Prevnar 13 and RotaTeq in
Studies 005 and 006
+ Prevnar 13 + RotaTeq
|Pentacel + RECOMBIVAX HB + Prevnar 13 + RotaTeq|
|Dose 1 (N=3,370)
|Injection Site Adverse Reactions||VAXELIS site||Pentacel or RECOMBIVAX HB site|
|Injection site erythema||Any||25.8||31.8||31.8||25.0||25.8||30.9|
|Injection site pain*||Any||53.3||49.0||44.9||55.8||43.7||44.4|
|Moderate or severe||16.3||14.1||12.5||19.1||11.3||10.8|
|Injection site swelling||Any||18.9||22.8||23.4||20.8||20.4||22.9|
|Systemic Adverse Reactions|
|Moderate or severe||7.0||5.5||4.8||6.8||3.9||5.0|
|Moderate or severe||24.6||23.4||20.1||25.7||19.2||16.8|
|Moderate or severe||15.0||11.5||8.5||14.5||9.4||8.2|
|Moderate or severe||3.5||2.6||2.1||2.8||3.1||1.0|
|N = Number of vaccinated participants with safety
* Moderate: cries and protests when injection site is touched; Severe: cries when injected limb is moved or the movement of the injected limb is reduced.
† Moderate: missed 1 or 2 feeds/meals completely; Severe: refuses ≥3 feeds or refuses most feeds.
‡ Moderate: requiring increased attention; Severe: inconsolable.
§ Moderate: not interested in surroundings or did not wake up for a meal; Severe: Sleeping most of the time or difficult to wake up.
¶ Moderate: 2-5 episodes per 24 hours; Severe: ≥6 episodes per 24 hours or requiring parenteral hydration. A subject with the same adverse reactions at both the Pentacel and RECOMBIVAX HB injection site, was counted once and was classified according to the highest intensity grading. Fever is based upon actual temperatures recorded with no adjustments due to the measurement route. Following Doses 1-3 combined, the proportion of temperature measurements that were taken by rectal, axillary, or other routes were 91.7%, 8.1%, and 0% respectively, for VAXELIS group, and 90.3%, 9.7%, and 0%, respectively, for Pentacel + RECOMBIVAX HB vaccines group.
Non-Fatal Serious Adverse Events
Across Studies 005 and 006, within 30 days following any infant dose vaccination, 68 participants (2.0%) who received VAXELIS and concomitant vaccines versus 19 participants (2.2%) who received Control and concomitant vaccines experienced a serious adverse event. Of these, a vaccine-related SAE was reported for no participants in the Control vaccines group and for 4 participants (0.1%) in the VAXELIS group:
- 3 of these 4 experienced pyrexia 1 to 2 days following the first study vaccinations; and
- 1 of these 4 experienced an apparent life threatening event (vomiting followed by pallor and lethargy) on the day of the first study vaccinations, and again 2 days later.
In the 2 US studies, death was reported in 6 participants (0.2%) who received VAXELIS and in 1 participant (0.1%) who received Pentacel + RECOMBIVAX HB vaccines; none were assessed as vaccine-related. Causes of death among infants who received VAXELIS were asphyxia, hydrocephalus, unknown cause, sepsis and 2 cases of Sudden Infant Death Syndrome (occurring 1, 2, 10, 42, 44 and 49 days post-vaccination, respectively). Across all 6 clinical studies, there were no deaths assessed as related to VAXELIS.
Data From Postmarketing Experience
The following adverse events have been reported during post-marketing use of other vaccines containing the antigens of VAXELIS. These adverse events are included based on a suspected causal connection to components of DAPTACEL, IPOL® (Poliovirus Vaccine Inactivated), COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] and use of VAXELIS outside of the US. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.
Immune System Disorders
Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
General Disorders And Administration Site Conditions
Extensive swelling of injected limb (including swelling that involves adjacent joints).
Seizure, febrile seizure.
Read the entire FDA prescribing information for Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine)