VAXELIS- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, bordetella pertussis fimbriae 2/3 antigen, poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), poliovirus type 3 antigen (formaldehyde inactivated), hepatitis b virus subtype adw hbsag surface protein antigen and haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen injection, suspension
MCM Vaccine Co.
VAXELIS™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).
For intramuscular use only.
VAXELIS is to be administered as a 3-dose series at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Three doses of VAXELIS constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
VAXELIS may be used to complete the hepatitis B immunization series.
A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series. [See Pertussis Vaccination Following VAXELIS.]
Pertussis Vaccination following VAXELIS
VAXELIS, Pentacel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine): DTaP-IPV/Hib], Quadracel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine): DTaP-IPV] and DAPTACEL® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed): DTaP] contain the same pertussis antigens manufactured by the same process. Children who have received a 3-dose series of VAXELIS should complete the primary and pertussis vaccination series with Pentacel, Quadracel or DAPTACEL according to the respective prescribing information in the approved package inserts. [See ADVERSE REACTIONS (6.1) AND CLINICAL STUDIES (14).]
Administration of VAXELIS following previous doses of other DTaP-containing Vaccines
VAXELIS may be used to complete the first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or DAPTACEL and are also scheduled to receive the other antigens in VAXELIS. Data are not available on the safety and immunogenicity of such mixed sequences.
Data are not available on the safety and effectiveness of using VAXELIS following 1 or 2 doses of a DTaP vaccine from a different manufacturer.
Administration of VAXELIS following previous doses of any Hepatitis B Vaccine
A 3-dose series of VAXELIS may be administered to infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at 1 month of age. [See ADVERSE REACTIONS (6.1) AND CLINICAL STUDIES (14).]
VAXELIS may be used to complete the hepatitis B vaccination series following 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Administration of VAXELIS following previous doses of Inactivated Polio Vaccine (IPV)
VAXELIS may be administered to infants and children who have received 1 or 2 doses of IPV and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Administration of VAXELIS following previous doses of Haemophilus b Conjugate Vaccines
VAXELIS may be administered to infants and children who have received 1 or 2 doses of H. influenzae type b Conjugate Vaccine and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Just before use, shake the vial until a uniform, white, cloudy suspension results.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered.
Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of VAXELIS intramuscularly.
In infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of injection. The vaccine should not be injected into the gluteal area.
VAXELIS should not be combined through reconstitution or mixed with any other vaccine.
VAXELIS is a suspension for injection in 0.5 mL single-dose vials. [See HOW SUPPLIED/STORAGE AND HANDLING (16).]
Do not administer VAXELIS to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine [See DESCRIPTION (11).]
Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause.
Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
If any of the following events occur after administration of a pertussis vaccine, the decision to administer VAXELIS should be based on careful consideration of potential benefits and possible risks.
- Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.
- Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
- Persistent, inconsolable crying lasting ≥3 hours within 48 hours.
- Seizures with or without fever within 3 days.
A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS. (1)
If VAXELIS is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on consideration of the infant’s medical status and the potential benefits and possible risks of vaccination.
Vaccination with VAXELIS may not protect all individuals.
Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease following vaccination with VAXELIS. [See DRUG INTERACTIONS (7.1).]
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%).
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.
|Study||Vaccine||Concomitantly Administered Vaccines|
|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])|
|005 *||VAXELIS at 2, 4, 6 months and DAPTACEL + PedvaxHIB® at 15 months||RotaTeq® at 2, 4, and 6 monthsPrevnar 13® at 2, 4, 6, and 15 months|
|Control group vaccines:Pentacel at 2, 4, 6 months and RECOMBIVAX HB® at 2 and 6 monthsDAPTACEL+ 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 monthsPrevnar 13 at 2, 4, 6, and 15 months|
|Control group vaccines:Pentacel at 2, 4, 6, and 15 monthsRECOMBIVAX HB at 2 and 6 months||RotaTeq at 2, 4, and 6 monthsPrevnar 13 at 2, 4, 6, and 15 months|
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.
|VAXELIS + Prevnar 13 + RotaTeq||Pentacel + RECOMBIVAX HB + Prevnar 13 + RotaTeq|
|Dose 1 (N=3,370)(%)||Dose 2 (N=3,221)(%)||Dose 3 (N=3,134)(%)||Dose 1 (N=880)(%)||Dose 2 (N=849)(%)||Dose 3 (N=825)(%)|
|Injection Site Adverse Reactions||VAXELIS site||Pentacel or RECOMBIVAX HB site|
|N = Number of vaccinated participants with safety follow-up.|
|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|
|Decreased Appetite †||Any||28.9||24.2||23.2||25.8||20.5||20.1|
|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|
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.
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