Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule

Avdicová, M; Príkazský, V.; Hudečková, Henrieta; Schuerman, Lode; Willems, Paul

doi:10.1007/s00431-002-1079-5

Cited by 49 publications

(26 citation statements)

References 28 publications

(33 reference statements)

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“…In children vaccinated with 2 doses of DTPa-HBV-IPV/Hib at 3 and 5 months of age, 96.8% had anti-HBs antibodies ≥10 mIU/ml, increasing to 98.9% after the third dose at 11-12 months of age [11]. These results are similar to those observed when monovalent HBV is co-administered with DTPa-IPV/Hib at 3, 5 and 11-12 months [12].…”

Section: Introductionsupporting

confidence: 92%

“…Results of the primary vaccination study (study 031) conducted in 1998-1999 have been reported previously [12]. The phase 4 open, follow up and challenge study was conducted in 12 centres in Slovakia between 07 June 2010 and 26 November 2010 (113954, www.clinicaltrials.gov NCT01138098) according to Good Clinical Practice guidelines and the Declaration of Helsinki.…”

Section: Methodsmentioning

confidence: 99%

“…We evaluated antibody persistence 10-11 years after vaccination at 3, 5, 11-12 months with DTPa-HBV-IPV/Hib or monovalent HBV vaccine (Engerix TM B, GlaxoSmithKline Vaccines) co-administered with Infanrix TM -IPV/Hib (DTPa-IPV/Hib, GlaxoSmithKline Vaccines) [12], and assessed the ability of these children to mount an anamnestic response to a challenge dose of HBV vaccine at year 10-11.…”

Section: Introductionmentioning

confidence: 99%

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Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Avdicová¹,

Crasta²,

Hardt³

et al. 2015

Vaccine

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Section: Introductionsupporting

confidence: 92%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Avdicová¹,

Crasta²,

Hardt³

et al. 2015

Vaccine

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“…[2][3][4][5][6][7][8] Moreover, its immunogenicity profile was generally similar to that of currently available DTPa-based pentavalent vaccines plus monovalent HBV or Hib vaccines (DTPa-HBV-IPV plus Hib or DTPa-IPV Hib plus HBV vaccines).…”

Section: Immunogenicitymentioning

confidence: 73%

“…In Infanrix hexaÔ recipients, seroprotective antibody titers against diphtheria and tetanus toxoids and poliovirus type 1, 2 and 3 antigens were achieved in ‡95% of infants »1 month after primary vaccination [2][3][4][5][6] and in ‡99.3% of infants »1 month after booster vaccination (compared with ‡94.7% and 100% of infants who received comparator vaccines). [5][6][7][8] Vaccine response rates against the three pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) were ‡95.7% »1 month after primary vaccination [2][3][4][5][6] and ‡86.0% »1 month after booster vaccination (compared with ‡90.3% and 100% of infants who received comparator vaccines).…”

Section: Immunogenicitymentioning

confidence: 87%

Spotlight on DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™)†

Dhillon

2010

BioDrugs

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Infanrix hexa, administered intramuscularly, is a diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine, indicated for primary and booster vaccination of infants. Infanrix hexa should be administered as a two- or three-dose primary vaccination course in infants aged < or =6 months, followed by booster vaccination between 11 and 18 months of age, with an interval of at least 6 months between the last dose of primary vaccination and the booster dose. This spotlight reviews the immunogenicity and protective effectiveness, as well as the reactogenicity and safety of Infanrix hexa. Infanrix hexa as primary and booster vaccination was safe and highly immunogenic for all its component toxoids/antigens in infants aged <2 years, regardless of vaccination schedules. Its immunogenicity and safety profiles were generally similar to those of currently available vaccines, the diphtheria, tetanus and acellular pertussis-based pentavalent vaccines plus monovalent HBV or Hib vaccines. In large clinical studies, Infanrix hexa elicited a strong immune response against vaccine toxoids/antigens, as indicated by high seroprotection/seropositivity/vaccine response rates and geometric mean titers. Moreover, antibodies against vaccine toxoids/antigens persisted for up to a mean of approximately 6 years after booster vaccination, and the vaccine induced long-term immune memory against hepatitis B surface antigen and Hib antigen. A strong immune response against Infanrix hexa toxoids/antigens after primary vaccination was also induced in infants who had received a dose of HBV vaccine at birth and in pre-term infants, although the response in the latter group was somewhat lower than that in full-term infants. In addition, when coadministered with other childhood vaccines, the immunogenicity of Infanrix hexa or that of the concomitantly administered vaccine was generally not altered. Hexavalent vaccines, including Infanrix hexa, were protective against invasive Hib disease; Infanrix hexa is also expected to be protective against pertussis. Most solicited local and general symptoms with Infanrix hexa were mild to moderate in intensity and the vaccine was associated with few unsolicited adverse events. Available clinical data from more than 10 years' experience with the vaccine suggest that Infanrix hexa as primary and booster vaccination is a safe and useful option for providing protection against the common childhood diseases of diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B and invasive Hib disease.

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Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB)

Bar-On

Goldberg

Fraser

et al. 2009

Cochrane Database of Systematic Reviews

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Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule

Cited by 49 publications

References 28 publications

Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Lasting immune memory against hepatitis B following challenge 10–11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11–12 months of age

Spotlight on DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™)†

Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae B (HIB)

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