VAXNEUVANCE was studied in pediatric patients at increased risk for IPD

VAXNEUVANCE was studied in infants and children in eight randomized, double-blind clinical studies designed to evaluate immunogenicity, safety, and tolerability.

Phase 3 clinical trials for VAXNEUVANCE included:

Children born prematurely

Children living with HIV

Children living with sickle cell disease

Children who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT)

These medical conditions may decrease pediatric patients’ ability to generate adequate immune responses, increasing IPD risk.^1-3

For example, children born prematurely have ~5X greater risk for IPD vs infants born at full term.⁴

VAXNEUVANCE demonstrated strong immunogenicity in both infants and children who are healthy or at increased risk for IPD.

When considering how these patients may respond to a PCV, you will want to review data from clinical trials that included patients with certain immunocompromising conditions.⁵

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Study designs

In a descriptive analysis within Studies 8, 9, and 10, the safety and immunogenicity of VAXNEUVANCE were evaluated in enrolled preterm infants (<37 weeks gestation at birth). Participants were randomized to receive VAXNEUVANCE (N=142) or PCV13 (N=144) as a 4-dose series administered at 2, 4, 6, and 12 through 15 months of age. Participants in these studies may have received either US-licensed or non-US licensed concomitant vaccines according to the local recommended schedule.

Study 13 was a double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in children 5 through 17 years of age with sickle cell disease. Participants were randomized 2:1 to receive a single dose of VAXNEUVANCE (N=70) or PCV13 (N=34).

Study 14 was a double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE in HIV-infected children 6 through 17 years of age, with CD4+ T-cell count ≥200 cells per microliter and plasma HIV RNA value <50,000 copies/mL. Participants were randomized to receive a single dose of VAXNEUVANCE (N=203) or PCV13 (N=204), followed by PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent) two months later.

Study 15 was a double-blind, descriptive study that assessed the safety and immunogenicity of VAXNEUVANCE compared to PCV13 in participants, aged 3 through 74 years of age, who had received an allogeneic hematopoietic stem cell transplant (allo-HSCT) 3 to 6 months prior to enrollment. Pediatric participants (N=14) were randomized to receive 3 doses of VAXNEUVANCE (N=8) or PCV13 (N=6), administered 1 month apart. Twelve months after allo-HSCT, participants without chronic graft-versus-host disease (cGVHD) received a single dose of PNEUMOVAX^®23 (Pneumococcal Vaccine Polyvalent) and those with cGVHD received a fourth dose of VAXNEUVANCE or PCV13. All participants had a history of stable engraftment and none had severe graft-versus-host disease. IgG GMCs and OPA GMT were measured after dose 3 and 30 days following vaccination with the 4th dose of PCV or the single dose of PNEUMOVAX 23.

Allo-HSCT, allogeneic hematopoietic stem cell transplant; cGVHD, chronic graft-versus-host disease; GMC, geometric mean concentration (mcg/mL); GMT, geometric mean titer; HIV, human immunodeficiency virus; IgG, Immunoglobulin G; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; RNA, ribonucleic acid.

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Assess immune response vs PCV13

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References

Quinn CT, Wiedmann RT, Jarovsky D, et al. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023;7(3):414-421. doi:10.1182/bloodadvances.2022008037
Pittet LF, Posfay-Barbe KM. Vaccination of immune compromised children—an overview for physicians. Eur J Pediatr. 2021;180(7):2035-2047. doi:10.1007/s00431-021-03997-1
Altered immunocompetence. Centers for Disease Control and Prevention. Last reviewed August 1, 2023. Accessed January 8, 2024. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html
Weycker D, Farkouh RA, Strutton DR, Edelsberg J, Shea KM, Pelton SI. Rates and costs of invasive pneumococcal disease and pneumonia in persons with underlying medical conditions. BMC Health Serv Res. 2016;16:182. doi:10.1186/s12913-016-1432-4
Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. World Health Organization. October 19, 2013. Accessed January 26, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977

Indications and Usage

VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) is indicated for 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 individuals 6 weeks of age and older.

Select Safety Information

Do not administer VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated at 2, 4, 6, and 12 through 15 months of age, provided as a range across the 4-dose series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%), and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%), and injection-site induration (6.8%).

The reported solicited adverse reactions in children 7 through 11 months of age who received 3 doses of VAXNEUVANCE were: fever ≥38.0°C (21.9%), irritability (32.8%), injection-site erythema (28.1%), somnolence (21.9%), injection-site swelling (18.8%), injection-site pain (18.8%), injection-site induration (17.2%), decreased appetite (15.6%), and urticaria (1.6%).

The reported solicited adverse reactions in children 12 through 23 months of age who received 2 doses of VAXNEUVANCE were: fever ≥38.0°C (11.3%), irritability (35.5%), injection-site pain (33.9%), somnolence (24.2%), decreased appetite (22.6%), injection-site erythema (21.0%), injection-site swelling (14.5%), and injection-site induration (8.1%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications and Usage Indications and Usage

VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae

Select Safety Information Select Safety Information

Do not administer VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or

Do not administer VAXNEUVANCE^® (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

VAXNEUVANCE was studied in pediatric patients at increased risk for IPD

VAXNEUVANCE was studied in infants and children in eight randomized, double-blind clinical studies designed to evaluate immunogenicity, safety, and tolerability.