Safety, Tolerability, and Immunogenicity of Vaxelis™ after an Infant Series of either Vaxelis™ or Hexyon™.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

1. Is healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
2. Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age (based on a review of medical history), respectively.
3. Is male or female, from approximately 11 months to 13 months of age (=327 days to =396 days) inclusive, at the time of obtaining the informed consent.
4. A legally acceptable representative has provided documented informed consent for the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has a known or suspected impairment of immunological function.
2. Has known or history of functional or anatomic asplenia.
3. Has a known hypersensitivity to any component of the study vaccine.
4. Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system.
5. Has a bleeding disorder contraindicating intramuscular vaccination.
6. Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection.
7. Was born to a mother with a known history of hepatitis B infection.
8. *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.
9. Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
10. Has an uncontrolled neurologic disorder or uncontrolled epilepsy.
11. Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine.
12. Has received or is expected to receive immunosuppressive agents during the conduct of the study.
13. *Meets 1 or more of the following systemic corticosteroid exclusion criteria:
a. Has received systemic corticosteroids (equivalent of =2 mg/kg total daily dose of prednisone or =20 mg/d for persons weighing >10 kg) for =14 consecutive days and has not completed treatment at least 30 days before study entry.
b. Has received any systemic corticosteroids within 14 days before study vaccination.
c. Is expected to require any systemic corticosteroids during conduct of the study.
14. *Has received any licensed, non-live vaccine within the 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine prior to Visit 2 blood draw.
Exception: Participant may receive nonstudy pediatric licensed non-live vaccines on same day as study vaccine is given (Day 1).
Exception: Non-live influenza vaccine may be administered, but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine.
15. *Has received any licensed live vaccine within 30 days before receipt of study vaccine or is scheduled to receive any live vaccine prior to Visit 2 blood draw.
16. *Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
17. *Has participated in another clinical study of an investigational product within 2 months before study vaccination at Visit 1 (Day 1) or plans to participate anytime during the duration of the current clinical study. Participants previously or currently enrolled in a COVID-19 vaccine clinical study, or enrolled in observational studies may be included; these should be reviewed on a case-by-case basis for approval by the Sponsor.
18. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1 may be rescheduled for a time when these criteria are not met.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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