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Vaccine. 2018 Feb 8;36(7):986-996. doi: 10.1016/j.vaccine.2018.01.005. Epub 2018 Jan 12.

Immunization of preterm infants with GSK's hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: A review of safety and immunogenicity.

Author information

1
Hospital Infantil La Paz, Paseo de la Castellana, 261, 28046 Madrid, Spain. Electronic address: felix.omenaca@salud.madrid.org.
2
Fundación Centro de Estudios Infectológicos, C1425AWK Buenos Aires, Argentina. Electronic address: liliananvazquez@gmail.com.
3
GSK, Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2, 28760 Tres Cantos, Madrid, Spain. Electronic address: pilar.c.garcia-corbeira@gsk.com.
4
GSK, Av Fleming 20, B-1300 Wavre, Belgium. Electronic address: narcisa.x.mesaros@gsk.com.
5
GSK, Av Fleming 20, B-1300 Wavre, Belgium. Electronic address: linda.hanssens@gmail.com.
6
GSK, Av Fleming 20, B-1300 Wavre, Belgium. Electronic address: jan.x.dolhain@gsk.com.
7
GSK, Av Fleming 20, B-1300 Wavre, Belgium. Electronic address: ivonne.x.puente@gsk.com.
8
Department of Paediatrics, Paediatric Infectious Diseases and Immunology, University of Würzburg, Josef-Schneider-Str. 2, 97080 Würzburg, Germany. Electronic address: Liese_J@ukw.de.
9
HELIOS Dr. Horst Schmidt Kliniken, Children's Hospital, Ludwig-Erhard-Str. 100, 65199 Wiesbaden, Germany. Electronic address: Markus.Knuf@helios-kliniken.de.

Abstract

BACKGROUND:

Infants with history of prematurity (<37 weeks gestation) and low birth weight (LBW, <2500 g) are at high risk of infection due to functional immaturity of normal physical and immunological defense mechanisms. Despite current recommendations that infants with history of prematurity/LBW should receive routine immunization according to the same schedule and chronological age as full-term infants, immunization is often delayed.

METHODS:

Here we summarize 10 clinical studies and 15 years of post-marketing safety surveillance of GSK's hexavalent vaccine (DTPa-HBV-IPV/Hib), a combined diphtheria-tetanus-acellular-pertussis-hepatitis-B-inactivated-poliovirus-Haemophilus influenzae-type-b (Hib) conjugate vaccine, when administered alone, or co-administered with pneumococcal conjugate, rotavirus, and meningococcal vaccines and respiratory syncytial virus IgG to infants with history of prematurity/LBW in clinical trials.

RESULTS:

At least 92.5% of infants with history of prematurity/LBW as young as 24 weeks gestation in clinical studies were seropositive to all vaccine antigens after 3-dose primary vaccination with GSK's hexavalent DTPa-HBV-IPV/Hib vaccine, with robust immune responses to booster vaccination. Seropositivity rates and antibody concentrations to hepatitis B and Hib appeared lower in infants with history of prematurity/LBW than term infants. Between 13-30% of medically stable infants with history of prematurity developed apnea after vaccination with GSK's hexavalent DTPa-HBV-IPV/Hib vaccine; usually after dose 1. The occurrence of post-immunization cardiorespiratory events appears to be influenced by the severity of any underlying neonatal condition. Most cardiorespiratory events resolve spontaneously or require minimal intervention. GSK's hexavalent DTPa-HBV-IPV/Hib vaccine was well tolerated in co-administration regimens.

CONCLUSION:

GSK's hexavalent DTPa-HBV-IPV/Hib vaccine alone or co-administered with other pediatric vaccines has a clinically acceptable safety and immunogenicity profile when used in infants with history of prematurity/LBW for primary and booster vaccination. Additional studies are needed in very premature and very LBW infants. However, currently available data support using GSK's hexavalent DTPa-HBV-IPV/Hib vaccine to immunize infants with history of prematurity/LBW according to chronological age.

KEYWORDS:

DTPa-HBV-IPV/Hib; Hexavalent vaccine; Premature; Preterm; Primary vaccination

PMID:
29336924
DOI:
10.1016/j.vaccine.2018.01.005
[Indexed for MEDLINE]
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