Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content<i>Haemophilus influenzae</i>type b vaccine in Filipino children

Gatchalian, Salvacion; Ramakrishnan, Gunasekaran; Bock, Hans L.; Lefevre, Inge; Jacquet, Jeanne Marie

doi:10.4161/hv.6.8.12155

Cited by 6 publications

(3 citation statements)

References 21 publications

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“…The rate of local and general adverse events in this study is consistent with published data following DTPw booster vaccination 9 , 10 . Five subjects experienced febrile convulsion after vaccination.…”

Section: Discussionsupporting

confidence: 91%

A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzaetype b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers

Quiambao

Meeren

Kolhe

et al. 2012

Human Vaccines & Immunotherapeutics

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As progress toward global poliovirus eradication continues, more and more countries are moving away from use of oral poliovirus vaccines (OPV) to inactivated poliovirus vaccines (IPV) in national vaccination schedules. Reduction of antigen dose in IPV could increase manufacturing capacity and facilitate the change from OPV to IPV. Combination vaccines reduce the number of injections required to complete vaccination, thus playing an important role in maintaining high vaccine coverage with good public acceptability. Three formulations of a combined, candidate hexavalent diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b conjugate vaccine (DTPw-HBV-IPV/Hib, GlaxoSmithKline Biologicals) differing only in IPV antigen content (full-dose, half-dose and one-third dose as compared with available stand-alone IPV vaccines), were evaluated when administered to healthy toddlers. Controls received separately administered licensed DTPw-HBV/Hib and IPV vaccines. Immunogenicity was assessed before and one month after vaccination. Safety and reactogenicity data were assessed for 30 d after vaccination. A total of 312 Filipino children were vaccinated in their second year of life. Each DTPw-HBV-IPV/Hib formulation was non-inferior to control in terms of pre-defined criteria for IPV immunogenicity. Post-vaccination GMTs against each poliovirus type were increased between 4.2- and 37.9-fold over pre-vaccination titers. Non-inferiority to other vaccine antigens was also demonstrated. The safety profile of the 3 DTPw-HBV-IPV/Hib formulations resembled licensed DTPw-HBV/Hib Kft and IPV in terms of the frequency and intensity of adverse reactions after vaccination. Further investigation of DTPw-HBV-IPV/Hib containing reduced quantity of IPV antigen for primary vaccination in infants is warranted. This study is registered at www.clinicaltrials.gov NCT number: NCT01106092

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Section: Discussionsupporting

confidence: 91%

A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzaetype b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers

Quiambao

Meeren

Kolhe

et al. 2012

Human Vaccines & Immunotherapeutics

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“…The majority of subjects (ranging between 84 and 100 %) in each vaccine group achieved serum antibody concentration indicative of protection against diphtheria, tetanus, pertussis, hepatitis B, and Hib after 3-dose primary vaccination series. Other studies conducted in India and Philippines that used the same accelerated EPI schedule but vaccinated with different DTP-HB-Hib vaccine showed seroprotection rates similar to those observed in the present study [ 7 , 8 , 18 , 21 , 22 ].…”

Section: Discussionsupporting

confidence: 88%

“…Gatchalian et al vaccinated 94 healthy Philippines infants with DTPw-HBV/Hib 10 (Tritanrix™-HepB and Hiberix™, GlaxoSmithKline Biologicals, Rixensart, Belgium) with a schedule of 6, 10, and 14 weeks of age, without prior hepatitis B vaccination at birth. One month after the third dose, 100.0 and 94.7 % of subjects had anti-PRP concentration ≥0.15 and ≥1.0 μg/ml; 92.6, 100.0 and 78.5 % of subjects had seroprotective concentration against diphtheria, tetanus, and hepatitis B; and 98.9 % had pertussis vaccine response, respectively [ 8 ]. Chatterjee et al vaccinated 89 healthy Indian infants, who had received one dose of the Hep B vaccine within 1 week of birth, with DTPw-HBV/Hib 10 (Tritanrix™-HepB and Hiberix™) with a schedule of 6, 10, and 14 weeks of age.…”

Section: Discussionmentioning

confidence: 99%

The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

et al. 2015

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BackgroundWHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine.MethodsA prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013.Subjects were divided into three groups with different batch number. Healthy infants 6–11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose.ResultsOf 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 μg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %.None Serious Adverse events (SAEs) considered related to study vaccine or procedure.ConclusionsThe 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles.Trial registrationNCT01986335 – October 30th 2013.

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Combination Vaccines

Decker¹,

Edwards²,

Howe³

2018

Plotkin's Vaccines

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Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen contentHaemophilus influenzaetype b vaccine in Filipino children

Cited by 6 publications

References 21 publications

The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

Combination Vaccines

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