title: The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule.
abstract: BACKGROUND
  WHO 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  Of 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.
  
  
  CONCLUSIONS
  The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles.
  
  
  BACKGROUND
  NCT01986335 - October 30(th) 2013.
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia. kusnandi@hotmail.com.
authors.forename: Kusnandi
authors.initials: K
authors.lastname: Rusmil
authors.affiliation: Child Health Department, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
authors.forename: Hartono
authors.initials: H
authors.lastname: Gunardi
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Eddy
authors.initials: E
authors.lastname: Fadlyana
authors.affiliation: Child Health Department, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
authors.lastname: Soedjatmiko
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Meita
authors.initials: M
authors.lastname: Dhamayanti
authors.affiliation: Child Health Department, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
authors.forename: Rini
authors.initials: R
authors.lastname: Sekartini
authors.affiliation: Child Health Department, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
authors.forename: Hindra Irawan
authors.initials: HI
authors.lastname: Satari
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Nelly Amalia
authors.initials: NA
authors.lastname: Risan
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Dwi
authors.initials: D
authors.lastname: Prasetio
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Rodman
authors.initials: R
authors.lastname: Tarigan
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Reni
authors.initials: R
authors.lastname: Garheni
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Mia
authors.initials: M
authors.lastname: Milanti
authors.affiliation: Child Health Department, Faculty of Medicine, University of Indonesia / Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
authors.forename: Sri Rezeki
authors.initials: SR
authors.lastname: Hadinegoro
authors.affiliation: Child Health Department, Faculty of Medicine, Padjadjaran University / Dr. Hasan Sadikin Hospital, Bandung, Indonesia.
authors.forename: Suganda
authors.initials: S
authors.lastname: Tanuwidjaja
authors.affiliation: PT. Bio Farma, Bandung, Indonesia.
authors.forename: Novilia Sjafri
authors.initials: NS
authors.lastname: Bachtiar
authors.affiliation: PT. Bio Farma, Bandung, Indonesia.
authors.forename: Rini Mulia
authors.initials: RM
authors.lastname: Sari
mesh_terms: D000917:Antibody Formation; D016667:Bacterial Capsules / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D011446:Prospective Studies
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine