Below are the abbreviated inclusion and exclusion criteria for this trial. Please don’t hesitate to reach out to one of the sites for more information or clarification about them.

Inclusion Criteria

Each student must meet all the following criteria to be enrolled in this study:

  1. 6 to 16 years of age.
  2. Provide consent to be in the study and understand and comply with the visits and testing plans.
  3. Not pregnant or breastfeeding. If female and sexually active must use an approved form of birth control.
  4. Have stable health and agree to physical exam and provide information on medical history.
  5. Have access to a consistent and reliable means of electronic or telephone contact.
  6. Refrain from routine nasal sprays (including steroid sprays) or washes for at least 7 days following any study vaccination.
  7. Seek medical attention when needed.

Exclusion Criteria

Students meeting any of the following criteria (by review of medical history and participant  intake) will be excluded from the study:

  1. Recent vaccination against pertussis, tetanus or diphtheria or known pertussis  (whooping cough) infection in the past 3 years.
  2. Has a chronic significant illness or history of a significant illness that is actively being treated or followed.
  3. Has a history of cancer.
  4. Uses smoking products (including vaping) and is unwilling to refrain from use for the first month of the study.
  5. On medications that affect the immune function or has recently received blood products.
  6. Recent oral or nasopharynx surgery (eg, adenoidectomy, tonsillectomy).
  7. A known hypersensitivity to latex or any component of any study vaccine.
  8. Participation in a clinical trial (or planning to) with the exception of certain COVID-19 trials.
  9. Repeated close contact with, or is currently living in a household with an immunocompromised individual.
  10. Resides in a residence during the first part of the study where an infant less than 6 months of age resides or may reside.