Phase 4
N=168
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
Vaccines, Combined · Hexavalent Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT05289271 ↗Enrolled (actual)
168
Serious AEs
0.6%
Results posted
Sep 2023
Primary outcome: Primary: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) — 52.9; 50.0; 74.1; 56.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vaxelis™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
52.9; 50.0; 74.1; 56.1; 52.9; 40.2 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic AE |
43.5; 36.6; 77.6; 58.5; 64.7; 47.6 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs |
97.6; 92.7 | — |
| PRIMARY Percentage of Participants With a Serious AE (SAE) |
0.0; 1.2 | — |
| PRIMARY Percentage of Participants With Diphtheria Toxoid Antibodies ≥0.1 IU/mL |
100.0; 98.6 | — |
| PRIMARY Percentage of Participants With Tetanus Toxoid Antibodies ≥0.1 IU/mL |
98.6; 98.6 | — |
| PRIMARY Percentage of Participants With Pertussis Toxoid (PT) Vaccine Response |
98.4; 94.4 | — |
| PRIMARY Percentage of Participants With Filamentous Hemagglutinin (FHA) Vaccine Response |
98.4; 90.1 | — |
| PRIMARY Percentage of Participants With Haemophilus Influenzae Type b Polyribosylribitol Phosphate (Hib-PRP) Antibodies ≥1.0 µg/mL |
89.0; 90.8 | — |
| PRIMARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Antibodies ≥10 mIU/mL |
100.0; 94.2 | — |
| PRIMARY Percentage of Participants With Poliovirus Serotype 1 Neutralizing Antibodies (Nab) ≥1:8 Dilution |
100.0; 95.7 | — |
| PRIMARY Percentage of Participants With Poliovirus Serotype 2 Neutralizing Antibodies (Nab) ≥1:8 Dilution |
100.0; 100.0 | — |
| PRIMARY Percentage of Participants With Poliovirus Serotype 3 Neutralizing Antibodies (Nab) ≥1:8 Dilution |
97.0; 100.0 | — |
| SECONDARY Percentage of Participants With Pertactin (PRN) Vaccine Response |
92.2; 22.5 | — |
| SECONDARY Percentage of Participants With Fimbriae 2/3 (FIM 2/3) Vaccine Response |
95.3; 69.0 | — |
Summary
The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.
Eligibility Criteria
Inclusion Criteria
- Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age
Exclusion Criteria
- Has known or suspected impaired immunological function
- Has known or history of functional or anatomic asplenia.
- Has a known hypersensitivity to any component of the study vaccine.
- Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system
- Has a bleeding disorder contraindicating intramuscular vaccination
- Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
- Was born to a mother with a known history of hepatitis B infection
- Had a recent febrile illness (defined as rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring at or within 72 hours prior to receipt of study vaccine
- Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine
- Has an uncontrolled neurologic disorder or uncontrolled epilepsy.
- Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine
- Has received or is expected to receive an immunosuppressive agent
- Meets corticosteroid use criteria
- Has received any licensed, non-live vaccine within 14 days of study vaccine
- Has received any license live vaccine within 30 days of study vaccine
- Has received a blood transfusion or blood product within 6 months of study vaccine
Data sourced from ClinicalTrials.gov (NCT05289271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.