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Human rotavirus vaccine immunogenic, well tolerated for preterm infants
Omenaca F. Pediatr Infect Dis J. 2012;doi:10.1097/INF.0b013e3182490a2c.
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Human rotavirus vaccine administered in two oral doses seems safe and effective for medically stable preterm infants and should be administered when or after they are discharged from the neonatal intensive care unit, according to a study published online.
Felix Omenaca, MD, PhD, and colleagues examined data of 988 medically stable preterm infants born in hospitals in France, Portugal, Poland and Spain.
The researchers grouped preterm infants by ages — infants born at gestational ages 27 to 30 weeks and those born at 30 to 36 weeks. They administered rotavirus vaccine (RIX4414, GlaxoSmithKline) in two doses to 658 preterm infants, and 330 received a placebo along with routine vaccinations, including diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type B and poliovirus. Infants from France and Spain also received Streptococcus pneumoniae concomitantly; infants from Portugal and Spain also received Neisseria meningitides.
The researchers then asked parents/guardians to report adverse effects, and they noted no statistically significant difference in the reporting of severe adverse reactions in the vaccine or placebo group (5.1% and 6.2%, respectively). Unsolicited adverse effects, which included fever of more than 39.5°C, six or more bouts of diarrhea per day, three or more episodes of vomiting per day, appetite loss and irritability, were reported in 29.3% of preterm infants in the vaccine group and 40.7% in the placebo group.
The researchers said the anti-rotavirus immunoglobulin A seroconversion rate 30 to 83 days after dose two of the vaccine was 85.7% for vaccine recipients and 16% for placebo recipients.
The researchers noted some study limitations; specifically that it was not designed to compare the early and late gestational age study groups. Because the rotavirus vaccine/placebo was administered with other vaccines, it could not be discerned if the reactogenicity was caused by the rotavirus vaccine or another vaccine.
However, the researchers reported that because of the higher risk that human rotavirus poses to preterm infants, the study supports this vaccine’s use in those older than 27 weeks who are “medically stable at the time of or after discharge from the neonatal unit.”
Disclosure: A number of researchers reported financial ties to GlaxoSmithKline Biologicals, which funded the study.
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