Vaccine Information: VAXELIS

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.

1 INDICATIONS AND USAGE

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).

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Vaccination Schedule

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.

2.2 Administration

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.

3 DOSAGE FORMS AND STRENGTHS

VAXELIS is a suspension for injection in 0.5 mL single-dose vials. [See HOW SUPPLIED/STORAGE AND HANDLING (16).]

4 CONTRAINDICATIONS

4.1 Hypersensitivity

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).]

4.2 Encephalopathy

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.

4.3 Progressive Neurologic Disorder

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.

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

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.

5.2 Adverse Reactions Following Prior Pertussis Vaccination

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.

5.3 Guillain-Barré Syndrome and Brachial Neuritis

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)

5.4 Altered Immunocompetence

If VAXELIS is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

5.5 Apnea in Premature Infants

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.

5.6 Limitations of Vaccine Effectiveness

Vaccination with VAXELIS may not protect all individuals.

5.7 Interference with Laboratory Tests

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).]

6 ADVERSE REACTIONS

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%).

6.1 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
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])
*
The first dose of Hepatitis B vaccine was administered prior to study initiation (prior to or at 1 month of age).
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.

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
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.
*
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.
Injection site erythema Any 25.8 31.8 31.8 25.0 25.8 30.9
≥2.5 cm 0.9 1.0 1.3 1.1 1.1 1.2
>5.0 cm 0.0 0.1 0.2 0.3 0.2 0.1
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
Severe 2.8 2.5 2.0 3.2 1.9 1.3
Injection site swelling Any 18.9 22.8 23.4 20.8 20.4 22.9
≥2.5 cm 2.5 1.6 1.7 2.7 1.3 0.8
>5.0 cm 0.2 0.2 0.2 0.3 0.1 0.0
Systemic Adverse Reactions
Fever ≥38°C 19.2 29.0 29.3 14.6 18.0 17.8
≥38.5°C 5.3 11.5 13.2 3.4 6.5 8.1
≥39.5°C 0.2 0.7 1.5 0.1 0.2 0.9
Crying Any 52.0 49.5 45.1 50.6 47.0 40.6
>1 hour 18.6 19.8 16.7 20.6 16.8 14.1
>3 hours 3.6 3.8 3.4 4.4 4.0 2.9
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
Severe 0.5 0.5 0.5 0.6 0.2 0.0
Irritability Any 61.8 58.9 55.2 61.7 56.3 51.6
Moderate or severe 24.6 23.4 20.1 25.7 19.2 16.8
Severe 2.5 3.8 2.9 2.2 2.7 2.2
Somnolence § Any 56.3 47.8 40.8 55.2 44.1 38.8
Moderate or severe 15.0 11.5 8.5 14.5 9.4 8.2
Severe 1.5 1.1 1.0 1.7 0.6 1.1
Vomiting Any 13.1 11.5 9.5 11.3 9.7 6.9
Moderate or severe 3.5 2.6 2.1 2.8 3.1 1.0
Severe 0.4 0.2 0.1 0.5 0.6 0.1

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.

Deaths

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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