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
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
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.