Indications for: VAXNEUVANCE
Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in patients aged ≥6 weeks.
The pivotal double-blind, active comparator-controlled phase 3 PNEU-AGE (ClinicalTrials.gov Identifier: NCT03950622) study compared the safety, tolerability and immunogenicity of Vaxneuvance to PCV13 (Prevnar® 13) in 1205 healthy adults 50 years of age and older who were pneumococcal vaccine-naïve.
Findings showed that Vaxneuvance was noninferior to Prevnar 13 for the 13 shared serotypes and elicited superior opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) for shared serotype 3 and for serotypes 22F and 33F (the 2 serotypes not included in PCV13).
Additionally, the double-blind, descriptive phase 3 studies, PNEU-PATH (ClinicalTrials.gov Identifier: NCT03480763) and PNEU-DAY (ClinicalTrials.gov Identifier: NCT03547167), compared the safety, tolerability and immunogenicity of Vaxneuvance to PCV13. The PNEU-PATH study included 652 healthy adults aged 50 years or older who received Vaxneuvance or PCV13 followed by Pneumovax® 23 one year later. The PNEU-DAY study included 1514 adults aged 18 to 49 years at increased risk of pneumococcal disease who received Vaxneuvance or PCV13 followed by Pneumovax 23 six months later.
Results from the PNEU-PATH study demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in Vaxneuvance. Findings from PNEU-PATH and PNEU-DAY showed that Vaxneuvance generated immune responses comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days postvaccination, based on OPA responses.
- Double-blind, randomized study of adults 50 years of age and older.
- Participants received Vaxneuvance concomitantly with seasonal inactivated quadrivalent influenza vaccine (QIV; n=600) or Vaxneuvance 30 days after receiving QIV (n=600).
- Noninferiority criteria for the comparisons of GMTs were met for the 15 pneumococcal serotypes in Vaxneuvance and for the 4 influenza vaccine strains tested.
In the multicenter, randomized, double-blind, active-comparator-controlled phase 3 PNEU-PED study (ClinicalTrials.gov Identifier: NCT03893448), the safety, tolerability, and immunogenicity of Vaxneuvance were compared with PCV13 in 1720 healthy infants enrolled at 42 to 90 days of age.
Results from the trial showed that Vaxneuvance met the primary and key secondary endpoints demonstrating noninferiority to PCV13 for all 13 shared serotypes at 30 days post vaccination, and superiority to PCV13 for shared serotype 3 and serotypes 22F and 33F.
Additionally, the multicenter, randomized, double-blind, active comparator-controlled phase 3 PNEU-DIRECTION interchangeability (ClinicalTrials.gov: NCT03620162) and PNEU-PLAN catch-up (ClinicalTrials.gov: NCT03885934) studies compared the safety, tolerability, and immunogenicity of Vaxneuvance to PCV13 in 900 healthy infants 42 to 90 days of age and 606 participants 7 months to 17 years of age, respectively.
Findings from both studies showed that Vaxneuvance met the primary immunogenicity endpoint with comparable immune response to PCV13 for all 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post vaccination.
Children Receiving Vaxneuvance to Complete 4-Dose Series Initiated With Prevnar 13
- Double-blind, active comparator-controlled descriptive study.
- Participants were randomly assigned to 1 of 5 vaccination groups.
- Two groups received a 4-dose series of Vaxneuvance (n=180) or Prevnar 13 (n=179).
- Remaining 3 groups received either 1, 2, or 3 doses of Prevnar 13 followed by Vaxneuvance to complete the 4-dose series (n=180, 180, and 181, respectively).
- Immune responses for the 13 shared serotypes at 30 days postdose 4 were numerically similar for participants completing the series with Vaxneuvance compared with those who received the complete series with Prevnar 13.
Children and Adolescents Receiving Catch-Up Vaccination
- Double-blind, active comparator-controlled descriptive study.
- Three age cohorts: 7-11 months, 12-23 months, 2-17 years.
- Randomly assigned to receive Vaxneuvance (n=303) or Prevnar 13 (n=303).
- Two youngest cohorts: pneumococcal vaccine-naïve at enrollment.
- Oldest cohort: pneumococcal vaccine-naïve, not fully vaccinated, or had completed a dosing regimen with a lower valency pneumococcal conjugate vaccine (excluding Prevnar 13).
- Pneumococcal vaccine-naïve received 1 to 3 doses of Vaxneuvance or Prevnar 13.
- Participants 2-17 yrs received 1 dose of Vaxneuvance.
- Catch-up vaccination with Vaxneuvance elicited immune responses at 30 days following the last dose of vaccine, in children 7 months through 17 years of age that were numerically similar to Prevnar 13 for the shared serotypes and higher than Prevnar 13 for the unique serotypes 22F and 33F.
Concomitant Vaccine Administration: Pentacel, Vaqta, M-M-R II, Varivax, Hiberix
- Concomitant administration of Pentacel with each of the 3 infant doses of either Vaxneuvance (n=598) or Prevnar 13 (n=601) was evaluated 30 days following the third dose; concomitant administration of single doses of Vaqta, M-M-R II, Varivax and Hiberix with the fourth dose of either Vaxneuvance or Prevnar 13 was evaluated 30 days following vaccination.
- Compared with Prevnar 13, there was no evidence that Vaxneuvance interfered with immune responses to these vaccines.
- Immune responses to the antigens in Pentacel following completion of the 4-dose series were not evaluated.
Concomitant Vaccine Administration: Recombivax HB
- Concomitant administration of Recombivax HB with either Vaxneuvance (n=124) or Prevnar 13 (n=266) was evaluated 30 days following the third dose of pneumococcal conjugate vaccine.
- Compared with Prevnar 13, there was no evidence that Vaxneuvance interfered with immune response to Recombivax HB.
Give by IM inj. ≥18yrs: 1 dose (0.5mL).
Give each dose (0.5mL) by IM inj. <6wks: not established. ≥6wks: 4 doses given at 2, 4, 6, and 12–15mos of age (and at least 2mos after the 3rd dose). May give 1st dose as early as 6wks of age. Previously unvaccinated infants and children: 7–11mos: 3 doses (give 1st 2 doses at least 4wks apart, 3rd dose after 1st birthday and separated by at least 2mos after 2nd dose); 12–23mos: 2 doses at least 2mos apart; 2–17yrs: 1 dose. Previously vaccinated with another pneumococcal conjugate vaccine: 2–17yrs: 1 dose; at least 2mos should elapse between receiving the last dose of another pneumococcal conjugate vaccine and Vaxneuvance.
Allergies to any diphtheria toxoid-containing vaccine.
Have appropriate medical treatment immediately available to manage allergic reactions. Immunocompromised. Premature infants: consider medical status and benefits/risks of vaccination (eg, apnea). Pregnancy. Nursing mothers.
Inj-site pain/swelling/erythema, fatigue, myalgia, headache, arthralgia.
Generic Drug Availability:
Single-dose prefilled syringes—1, 10