Primary vaccination of infants with diphtheria-tetanus-acellular pertussis–hepatitis B virus– inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections

Schmitt, H. J.; Knuf, M; Ortiz, Esteban; Sänger, Roland; Uwamwezi, Marie Chantal; Kaufhold, Achim

doi:10.1067/mpd.2000.107796

Cited by 78 publications

(35 citation statements)

References 26 publications

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“…The majority of subjects had seroprotective titres against diphtheria, tetanus, hepatitis B, poliovirus and Hib with antibody levels 1 month after the 2nd dose in the range of those observed 1 month after three-dose primary vaccination series [12,25], and reaching post-booster levels [14,16] after the 3rd dose. Although a surrogate marker (or markers) of protection against pertussis have not been identified, antibodies to pertussis antigens contained in acellular pertussis vaccines are implicated in protection [3,4,27].…”

Section: Discussionmentioning

confidence: 82%

“…A combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae b (DTPa-HBV-IPV/ Hib) vaccine has been developed to protect infants against six childhood diseases with a single injection and thus simplify the infant vaccination practice. This life [2,25]. Several European countries (including Italy, Sweden and Slovakia) recommend a 3, 5, 11 month infant vaccination schedule, which we have evaluated in our study.…”

Section: Introductionmentioning

confidence: 99%

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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

Avdicová¹,

Príkazský²,

Hudečková

et al. 2002

Eur J Pediatr

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Section: Discussionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

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

Avdicová¹,

Príkazský²,

Hudečková

et al. 2002

Eur J Pediatr

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“…The assay cut-off for pertussis antibodies was 5 ELISA Units (EL.U)/mL. As there is no established serological correlate of protection against pertussis, a vaccine response to pertussis was defined as the appearance of antibodies in initially seronegative infants or maintenance of pre-vaccination antibody concentration in infants who were seropositive prior to vaccination taking into account the natural decrease of maternal antibodies 18) . Neutralizing antibodies to poliovirus types 1, 2 and 3 were determined using a modification of the WHO micro-neutralization test method 19) with a titer of 8 considered protective.…”

Section: Analysis Of Immunogenicitymentioning

confidence: 99%

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants

Kim

Ho²,

Shin

et al. 2010

Korean J Pediatr Infect Dis

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∫∫ , Wavre, BelgiumPurpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix TM IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were 99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV ≥ groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization. (Korean J Pediatr Infect Dis 2010;17:156-168)

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“…Previous studies 12,13 established the immunogenicity of a novel combined DTPa-HBV-IPV vaccine and reported the vaccine to be safe and well tolerated. The purpose of this trial was to assess the safety and reactogenicity of the combined DTPa-HBV-IPV vaccine when coadministered as separate injections with commercially available Hib conjugate vaccines in comparison with coadministration of DTPa, Hib, and OPV as separate products in a large cohort of infants.…”

mentioning

confidence: 99%

Safety and Reactogenicity of a Novel DTPa-HBV-IPV Combined Vaccine Given Along With Commercial Hib Vaccines inComparison With Separate Concomitant Administration ofDTPa, Hib, and OPV Vaccines in Infants

et al. 2002

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ABSTRACT. Objective. Combination vaccines simplify vaccine administration and have the potential to promote compliance and cost-effectiveness by decreasing the number of injections needed to immunize a child. The objective of this study was to assess the safety and reactogenicity of the diphtheria-tetanus toxoid-acellular pertussis-hepatitis B virus-inactivated polio virus (DTPa-HBV-IPV) vaccine when coadministered with different Haemophilus influenzae type B (Hib) vaccines in comparison with separate, commercially available, control vaccines in a 3-dose primary vaccination series.Methods. An open-label, randomized, parallel-group study in 5318 infants who were 8 to 16 weeks of age at enrollment was conducted in 90 centers in Germany. The incidence of adverse events that occurred in infants who received the DTPa-HBV-IPV candidate vaccine coadministered with 1 of 4 different Hib vaccines (given in separate sites; groups 1-4) was compared with the incidence that occurred in infants who received commercially available control vaccines (DTPa, Hib, and oral polio virus [OPV] vaccine; group 5) administered separately. The vaccines were given as a 3-dose primary series at 3, 4, and 5 months of age. Infants were assessed for solicited local and general adverse events for 4 days and for unsolicited adverse events for 30 days after each vaccine dose. The primary endpoint was to rule out a 7.5% increase in infants who experienced grade 3 (defined as preventing normal everyday activities unless otherwise specified) solicited local and general adverse events over the 3-dose primary course after the combined DTPa-HBV-IPV vaccine coadministered with Hib as compared with commercially available vaccines.Results. During the 3-dose primary course, 490 of 3029 infants (16.2%) in the pooled DTPa-HBV-IPV vaccine groups and 151 of 744 (20.3%) in the control vaccine group experienced a grade 3 adverse event (rate difference [control minus combination] 4.1%; 90% confidence interval, 1.41-7.13). The lower limit of the 90% confidence interval of the observed difference remained above the prespecified ؊7.5% limit for noninferiority, thereby meeting the primary endpoint. The incidences of local injection-site reactions were similar for the DTPa-HBV-IPV and DTPa injection sites. Significant differences in the incidence of both local and general adverse events were observed depending on which of the Hib vaccines was coadministered. Infants who received Hib N meningitidis outer-membrane complex protein conjugate vaccine had greater incidences of fever and, to a lesser extent, greater reactions at the Hib injection site than did infants who received other Hib vaccines.Conclusions ABBREVIATIONS. DTPa, diphtheria-tetanus toxoid-acellular pertussis; HBV, hepatitis B virus; Hib, Haemophilus influenzae type b; IPV, inactivated polio virus; OPV, oral polio virus; ATP, according-to-protocol; ITT, intention-to-treat; CI, confidence interval; PRP-OMP, Haemophilus influenzae type b Neisseria meningitidis outer-membrane complex protein conjugate.

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Primary vaccination of infants with diphtheria-tetanus-acellular pertussis–hepatitis B virus– inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections

Cited by 78 publications

References 26 publications

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

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

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants

Safety and Reactogenicity of a Novel DTPa-HBV-IPV Combined Vaccine Given Along With Commercial Hib Vaccines inComparison With Separate Concomitant Administration ofDTPa, Hib, and OPV Vaccines in Infants

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