HIBTITER SUMMARY
Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) HibTITER is a sterile solution of a conjugate of oligosaccharides of the capsular antigen of
Haemophilus influenzae
type b (Haemophilus b) and diphtheria CRM197 protein (CRM197) dissolved in 0.9% sodium chloride.
Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) HibTITER is indicated for the immunization of children 2 months to 71 months of age against invasive diseases caused by
H. influenza
type b.
As with any vaccine, HibTITER may not protect 100% of individuals receiving the vaccine.
The American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) encourage the routine simultaneous administration of
Haemophilus influenzae
type b vaccines with other currently recommended vaccines, but at different sites (see DRUG INTERACTIONS).32,33,34,35
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NEWS HIGHLIGHTS
Published Studies Related to Hibtiter (Haemophilus b Vaccine)
A comparative study to evaluate the safety and immunogenicity of two lots of Haemophilus influenzae type-B conjugate vaccine manufactured at different scales. [2011.07.26]
OBJECTIVE: To compare the immunogenicity and safety of two different lots of SII Haemophilus influenzae type-B-tetanus toxoid conjugate (SII HibP(RO)) vaccine manufactured at different scales when given in 3-dose schedule. DESIGN: Phase IV, open label, comparative, randomized parallel group study. SETTING: Shirdi Sai Baba Hospital, Vadu Budruk, Pune and Pediatrics Department of King Edward Memorial Hospital Research Centre, Pune. SUBJECTS: 204 normal healthy infants of age 6-8 weeks at the time of first vaccination... CONCLUSION: SII HibP(RO) vaccines manufactured in small and industrial scale are equally immunogenic, safe and confer adequate seroprotection to infants of 6-14 weeks of age. Scaling up production process has not affected the safety and immune response in the target population. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Immediate and longer term immunogenicity of a single dose of the combined haemophilus influenzae type B-Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in primed toddlers 12 to 18 months of age. [2011.04]
Hib-primed but MenC-naive toddlers (N = 433) were randomized to receive 1 dose of Hib-MenC-TT or separate Hib-TT and MenC-CRM197 vaccines. One month later, noninferiority was demonstrated for serum bactericidal anti-MenC antibodies (rSBA) and Hib antipolyribosylribitol phosphate (PRP) antibodies; >99% in both groups had rSBA titer >/= 8 or anti-PRP concentration >/= 0.15 mug/mL.
Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study. [2011.03.03]
A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by >/= 15 days; staggered group).
Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age. [2011.03]
The coadministration of the combined meningococcal serogroup C conjugate (MCC)/Haemophilus influenzae type b (Hib) vaccine with pneumococcal conjugate vaccine (PCV7) and measles, mumps, and rubella (MMR) vaccine at 12 months of age was investigated to assess the safety and immunogenicity of this regimen compared with separate administration of the conjugate vaccines...
Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. [2011.03]
BACKGROUND: Neisseria meningitidis serogroups B, C, and Y cause most meningococcal disease in industrialized countries. A Haemophilus influenzae type b-meningococcal serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) was evaluated... CONCLUSIONS: HibMenCY-TT induced noninferior Hib and MenC responses compared with monovalent Hib and MenC conjugates with a comparable safety profile. Bactericidal antibodies against MenC/Y were induced after 2 doses of HibMenCY-TT.
Clinical Trials Related to Hibtiter (Haemophilus b Vaccine)
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma) [Completed]
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine
and immediate reactions within the first 30 minutes after injection.
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants [Completed]
In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current
formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be
double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current
formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV
vaccine.
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants [Recruiting]
Primary objective:
To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP),
Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3
antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B:
DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary
vaccination (all antigens).
Secondary objectives:
- To describe immune responses against all vaccine antigens with no pre-specified
hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose
4) in the two study groups (Group A and Group B).
- To describe the safety after each dose of each vaccine in the two study groups (Group A
and Group B).
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants [Completed]
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster
vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with
GSK Biologicals' rotavirus vaccine or Placebo.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules [Completed]
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will
be randomly allocated into two groups:
- one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis
B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine
at 6-10-14 weeks of age
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of
age
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