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™.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
168
Vaxelis™ 0.5 mL sterile suspension in prefilled syringe for intramuscular administration.
Gemeinschaftspraxis Dres. Adelt, Mettlich-Lambrecht und Denneberg ( Site 0053)
Bramsche, Lower Saxony, Germany
Kinderärztliche Gemeinschaftspraxis ( Site 0057)
Wolfsburg, Lower Saxony, Germany
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Solicited injection-site AEs are predefined local (at the injection/administration site) events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a Vaccination Report Card (VRC) to report the following solicited injection-site AEs : swelling, redness (erythema), and pain/tenderness. 95% confidence intervals (CIs) were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days postvaccination
Percentage of Participants With a Solicited Systemic AE
Solicited systemic AE are predefined systemic events for which the participant's legally authorized representative was specifically questioned. Participant's legally acceptable representative used a VRC to report the following solicited systemic AEs: vomiting, drowsiness (somnolence), loss of appetite, and irritability. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days postvaccination
Percentage of Participants With Unsolicited AEs
An unsolicited AE is an AE that was not solicited using a VRC and that is communicated by a participant's legally authorized representative who has signed the informed consent. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 15 days postvaccination
Percentage of Participants With a Serious AE (SAE)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kinder- und Jugendärzte Hürth-Park ( Site 0054)
Hürth, North Rhine-Westphalia, Germany
Private Practice - Dr. Petri, Kinderarztpraxis ( Site 0056)
Hürth, North Rhine-Westphalia, Germany
Gemeinschaftspraxis Matthias Donner & Dr. Martin Lüchtrath ( Site 0052)
Mönchengladbach, North Rhine-Westphalia, Germany
Kinderärzte im Recker Park ( Site 0058)
Würselen, North Rhine-Westphalia, Germany
A.O.U.C. Policlinico di Bari-Hygiene ( Site 0105)
Bari, Apulia, Italy
A.O.U. Policlinico Paolo Giaccone ( Site 0102)
Palermo, Sicily, Italy
CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 0001)
Santiago de Compostela, La Coruna, Spain
Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 0011)
Madrid, Madrid, Comunidad de, Spain
...and 3 more locations
Time frame: Up to 40 days postvaccination
Percentage of Participants With Diphtheria Toxoid Antibodies ≥0.1 IU/mL
Human antibodies to diphtheria toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with the lower limit of quantitation (LLOQ) for diphtheria antibody of 0.005 IU/mL. The percentage of participants with diphtheria toxoid antibodies ≥0.1 international units per milliliter (IU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Tetanus Toxoid Antibodies ≥0.1 IU/mL
Human antibodies to tetanus toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for tetanus antibody of 0.01 IU/mL. The percentage of participants with tetanus toxoid antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Pertussis Toxoid (PT) Vaccine Response
Human antibodies to pertussis toxoid were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for PT is based on pre-vaccination level of PT is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Filamentous Hemagglutinin (FHA) Vaccine Response
Human antibodies to FHA were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for FHA antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FHA response will be based on pre-vaccination level of FHA. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Haemophilus Influenzae Type b Polyribosylribitol Phosphate (Hib-PRP) Antibodies ≥1.0 µg/mL
Human antibodies to Hib-PRP were quantified using the Vacczyme™ Human Anti-Haemophilus influenzae Type b Enzyme Immunoassay Kit. Levels of anti-Hib IgG were quantified by interpolation from a standard curve that has been calibrated to the FDA lot 1983 reference serum. The percentage of participants with Hib-PRP antibodies ≥0.1 IU/mL one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Antibodies ≥10 mIU/mL
Human antibodies to HBsAg were quantified using an Enhanced Chemiluminescence (ECi) assay, with the hepatitis B WHO International reference standard at 10 mIU/mL as a control in every assay, and the LLOQ of the assay is 5 mIU/mL. The percentage of participants with HBsAg antibodies ≥10 milli-international per liter (mIU/mL) one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 1 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 1 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 1 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 1 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 2 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 2 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 2 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 2 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Poliovirus Serotype 3 Neutralizing Antibodies (Nab) ≥1:8 Dilution
Human antibodies to poliovirus serotype 3 were quantified with a neutralization assay by utilizing Vero cells and wild type poliovirus strain 3 as the challenge virus. The Karber method was used to determine the serum dilution that neutralized 50% of the challenge virus, with results expressed as titers (1:dilution), and the LLOQ was 1:4. dilution. The percentage of participants with poliovirus serotype 3 Nab ≥1:8 dilution one month after Vaxelis™ as the 3rd dose of a vaccination series is presented. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Pertactin (PRN) Vaccine Response
Human antibodies to PRN were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for PRN of 2.00 EU/mL.The percentage of participants meeting response criteria for PRN was based on pre-vaccination level of PRN. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)
Percentage of Participants With Fimbriae 2/3 (FIM 2/3) Vaccine Response
Human antibodies to FIM 2/3 were quantified using the Meso Scale Discovery Electrochemiluminescence serological assay based on an established reference standard sample curve with a LLOQ for pertussis antibody of 2.00 EU/mL. The percentage of participants meeting response criteria for FIM 2/3 was based on pre-vaccination level of FIM 2/3. The 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: 30 days postvaccination (at ~12 months of age)