A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary  and booster vaccination of healthy Turkish infants and toddlers

Mehmet CEYHAN; İnci YILDIRIM; Hasan TEZER; İlker DEVRİM; Emmanuel FEROLDI

Makale detayları

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers

Yazarlar:

Mehmet CEYHAN | İnci YILDIRIM | Hasan TEZER | İlker DEVRİM | Emmanuel FEROLDI

Yayıncı:

TUBITAK

Dergi:

Turkish Journal of Medical Sciences 2017 Vol.47 Issue 4, pp.1247-1256

Belge Tipi:

Makale

Yayın Tarihi:

7/2017

Belge Dili:

Türkçe

Document ID (Org No.):

2000751242

Sıklık:

İki Aylık

eISSN:

1303-6165

pISSN:

1300-0144

Özet:

 

Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15?18 months were evaluated.  Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports.  Results: Postprimary series noninferiority of anti-HB ≥≥\geq 10 mIU/mL was demonstrated for the DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-PRP-T than for standalone HB. For each antigen except HB, DTaP-IPV-HB-PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups.  Conclusion: The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

Makale detayları

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers

Yazarlar: Mehmet CEYHAN | İnci YILDIRIM | Hasan TEZER | İlker DEVRİM | Emmanuel FEROLDI

Yayıncı: TUBITAK

Dergi: Turkish Journal of Medical Sciences 2017 Vol.47 Issue 4, pp.1247-1256

Belge Tipi: Makale

Yayın Tarihi: 7/2017

Belge Dili: Türkçe

Document ID (Org No.): 2000751242

Sıklık: İki Aylık

eISSN: 1303-6165

pISSN: 1300-0144

Sayı

Yazarlar:

Mehmet CEYHAN | İnci YILDIRIM | Hasan TEZER | İlker DEVRİM | Emmanuel FEROLDI

Yayıncı:

TUBITAK

Dergi:

Turkish Journal of Medical Sciences 2017 Vol.47 Issue 4, pp.1247-1256

Belge Tipi:

Makale

Yayın Tarihi:

7/2017

Belge Dili:

Türkçe

Document ID (Org No.):

2000751242

Sıklık:

İki Aylık

eISSN:

1303-6165

pISSN:

1300-0144