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Pedvaxhib (Haemophilus Influenzae Type b Vaccine) - Summary

 
 



PEDVAXHIB SUMMARY

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is a highly purified capsular polysaccharide (polyribosylribitol phosphate or PRP) of Haemophilus influenzae type b (Haemophilus b, Ross strain) that is covalently bound to an outer membrane protein complex (OMPC) of the B11 strain of Neisseria meningitidis serogroup B. The covalent bonding of the PRP to the OMPC which is necessary for enhanced immunogenicity of the PRP is confirmed by quantitative analysis of the conjugate's components following chemical treatment which yields a unique amino acid. The potency of PedvaxHIB is determined by assay of PRP.

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

Liquid PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.

BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.)

Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see DOSAGE AND ADMINISTRATION).


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NEWS HIGHLIGHTS

Published Studies Related to Pedvaxhib (Haemophilus Influenzae Type 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.

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Clinical Trials Related to Pedvaxhib (Haemophilus Influenzae Type b Vaccine)

The Safety and Immunogenicity of Haemophilus Influenzae Type b Vaccine in Different Injection Site [Completed]
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

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.

Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age [Completed]
This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.

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).

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Page last updated: 2011-12-09

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