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)
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.2
Study Designs
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 1month 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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Indications and Usage for VAXNEUVANCE
VAXNEUVANCE 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 for VAXNEUVANCE
Do not administer VAXNEUVANCE 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 for VAXNEUVANCE
VAXNEUVANCE 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.
VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae
VAXNEUVANCE 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 for VAXNEUVANCE
Do not administer VAXNEUVANCE 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.
Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or
Do not administer VAXNEUVANCE 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.