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About
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North Carolina, and Cincinnati Children's Hospital Medical Center. Eligible infants will be randomized 1:1 to receive either 2-month US licensed childhood vaccines (PCV13, DTaP, HBV, IPV an Hib) or no vaccines. After their participation in the study, healthcare providers of the infants in the unvaccinated group will make decision abut receipt of their 2-month childhood vaccines. The study will collect data from the continuous cardiorespiratory and pulse oximetry monitors from randomization to 48 hours after randomization for infants in the unvaccinated group, and from randomization to 48 hours after vaccination for infants in the vaccinated group. Infants in both groups will be monitored for up to 60 hours for the occurrence of apnea, bradycardia, and oxygen desaturation. For infants in the "vaccinated" group, the study will also collect adverse events of clinical interest and serious adverse events occurring between the end of the 48-hour monitoring period and 14 days after vaccination. This information will be collected through parental report and review of medical records.
Full description
Modified Intent-to-Treat (mITT) Analysis Population: Defined as any infant that was enrolled and randomized in the study
For the mITT analysis, infants will be analyzed in their assigned treatment arms irrespective of receipt of vaccine. Study outcomes will be included in the analysis as follows:
i) Vaccinated group: study outcomes in the 48-hour monitoring after vaccination. If vaccination does not occur by 12 hours after randomization, then study outcomes will be assessed between 12 and 60 hours after randomization.
ii) Unvaccinated group: study outcomes in the 48-hour monitoring period after randomization.
Enrollment
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Inclusion criteria
Exclusion criteria
Receipt of DTaP, IPV, PCV13, or Hib prior to enrollment. Previous administration of the first dose of HBV is permitted
Anticipated receipt of any vaccine other than DTaP, IPV, HBV, PCV13, or Hib during the first 60 hours after randomization
History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any hepatitis B vaccine
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
History of latex allergy
Fever ≥38°C within 48 hours prior to randomization*
*This may result in a temporary delay of randomization
Active known respiratory infection within 48 hours prior to randomization*
*This may result in a temporary delay of randomization
Active infection being treated with systemic antimicrobials*
*This may result in a temporary delay of randomization
Requiring mechanical ventilation or support with nasal intermittent positive pressure ventilation (NIPPV)*
*This may result in a temporary delay of randomization
History of unstable progressive neurologic disorder of unknown cause
Known cause of apnea other than apnea of prematurity
Cyanotic heart disease (congenital or acquired)
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
Child or parent/LAR is an immediate relative of study staff or an employee who is supervised by study staff.
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
Primary purpose
Allocation
Interventional model
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223 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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