Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines

Inclusion Criteria:

1. ≤32 weeks gestational age at birth

2. ≥6 weeks postnatal age at randomization

3. Remains hospitalized after birth (has never been discharged home)

4. Treating clinician deems infant eligible to receive 2-month vaccines

5. English- or Spanish-speaking parent(s)/legally authorized representative(s) (LAR(s))

6. Not planned for discharge within 60 hours of study entry

7. The parent/guardian must be willing and capable of providing permission for their
child to participate through the written informed consent process

Exclusion Criteria:

1. Receipt of DTaP, IPV, PCV13, or Hib prior to enrollment. Previous administration of
the first dose of HBV is permitted

2. Anticipated receipt of any vaccine other than DTaP, IPV, HBV, PCV13, or Hib during the
first 60 hours after randomization

3. History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any
hepatitis B vaccine

4. History of a severe allergic reaction (e.g. anaphylaxis) to any component of the
vaccines used in the study including neomycin, yeast and polymyxin B

5. History of latex allergy

6. Fever ≥38°C within 48 hours prior to randomization*

*This may result in a temporary delay of randomization

7. Active known respiratory infection within 48 hours prior to randomization*

*This may result in a temporary delay of randomization

8. Active infection being treated with systemic antimicrobials*

*This may result in a temporary delay of randomization

9. Requiring mechanical ventilation or support with nasal intermittent positive pressure
ventilation (NIPPV)*

*This may result in a temporary delay of randomization

10. History of unstable progressive neurologic disorder of unknown cause

11. Known cause of apnea other than apnea of prematurity

12. Cyanotic heart disease (congenital or acquired)

13. Major invasive medical or surgical procedure (including circumcision) within 48 hours
prior to randomization or anticipated to have major invasive medical or surgical
procedure during the first 60 hours after randomization*

*This may result in a temporary delay of randomization

14. Child or parent/LAR is an immediate relative of study staff or an employee who is
supervised by study staff.

15. Any condition that would, in the opinion of the site investigator, place the
participant at an unacceptable risk of injury or render the participant unable to meet
the requirements of the protocol