|Tradename||Manufacturer||License||Vaccine type||Handling||Indication||Schedule(s)||Dosage||Reactogenicity||Safety||Warnings||Contraindication||Co-administration||Immunogenicity||Seroprotection rate||Antibody persistence||Efficacy||Effectiveness||Storage||Shelflife||Comments||VacciTUTOR||Literature|
|ENGERIX-B||GlaxoSmithKline Biologicals s.a.||EMA||Hepatitis B vaccine (recombinant protein; expressed in yeast)||0.5 mL single pediatric dose vials or prefilled syringes, 1.0 mL adult dose vials or prefilled syringes||Active immunizing agent against infection caused by all known subtypes of hepatitis B virus||Check "Vaccines summary"||check "Vaccines Summary"||The tip caps of the syringes contain natural rubber latex which may cause allergic reactions. Temporarily defer vaccination of infants with a birth weight less than|
2,000 g born to hepatitis B surface antigen (HBsAg)-negative mothers.
|Check "Vaccines summary"||with HPV vaccine CERVARIX, immune globulin, BCG, DTP, DT and/or polio vaccines, MMR, Hib and hepatitis A vaccines.||see below||Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.1 Seroconversion is defined as antibody titers ≥1 mIU/mL.||No data||2°C – 8°C||3 years||Chapter 37|
|RECOMBIVAX HB®||Merck||FDA||HBsAg recombinant protein expressed in yeast||RECOMBIVAX HB is available in single-dose vials and prefilled Luer-Lok® syringes.|
RECOMBIVAX HB DIALYSIS FORMULATION is available in single-dose vials
|prevention of infection caused by all known subtypes of hepatitis B virus||Check "Vaccines summary"||check "Vaccines Summary"||Hypersensitivity to Latex; Apnea in Premature Infants <2000 g (vaccination should be delayed until 1 month of age)||Check "Vaccines summary"||with DTwP; OPV; MMR; eIPV; VARIVAX®; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of DTaP may be administered concomitantly with HBIG. The first dose of RECOMBIVAX HB may be given at the same time as HBIG, but the injections should be administered at different sites.||see below||No data||2-8°C , protect from light||3 years||Chapter 37||Link
|HEPLISAV B||Dynavax||EMA||recombinant HBsAg protein, CPG-adjuvanted||Solution for injection in pre-filled syringe.||prevention of infection caused by all known subtypes of hepatitis B virus||approved for use in adults >18 years of age; 2 doses 1 month apart||One dose (0.5 ml) contains:|
HBsAg 20 µg adjuvanted with 3000 µg CpG 1018, a 22-mer oligonucleotide comprising microbial DNA-like unmethylated CpG motifs; produced in yeast (Hansenula polymorpha) by recombinant DNA technology
|Check "Vaccines summary"||Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed.||HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. ICH may have a diminished immune response to HEPLISAV-B.||Check "Vaccines summary"||No data, co-administration is not recommended. Concomitant administration of HEPLISAV B with hepatitis B immunoglobulin (HBIG) has not been studied.||Based on seroprotection rate - below||Protective immunity (anti-HBsAg ≥ 10 mIU/mL) achieved in 95% adults 18-55 years after full course of vaccination; and in 90% of adults 40 - 70 Years||Clinical trials indicate higher seroprotection rate than non-adjuvanted product.||No data||2°C to 8°C||3 years||
|PREHEVBRIO||VBI Vaccines (Delaware) Inc||FDA||Hepatitis B vaccine (recombinant HBsAg)||package of 10 single dose vials||Prevention of hepatitis B||≥ 18 years: three doses at 0-, 1- and 6-months||10 µg recombinant hepatitis B surface antigens (pre-S1, pre-S2, and S) adsorbed on aluminum hydroxide adjuvant (0.5 mg/mL)||Check "Vaccines summary". For rare side effects check product profile.||check "Vaccines Summary"||do not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infrvtion, ICH may have reduced immune response.||Check "Vaccines summary"||NA||was evaluated in comparison with a US-licensed hepatitis B vaccine (Engerix-B).||anti-HBs titers ≥ 10 mIU/mL||NA||91.4 (89.1, 93.3) (evaluated in comparison with Engerix SPRs)||NA||2°C to 8°C . Protect from light.||36 months|
|Infanrix hexa||GSK||EMA FDA||DTaP-HBV-IPV- Hib vacccine (adsorbed)||pre-filled syringe||ctive immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday )||see locally recommended schedule for infants immunization||Check "Vaccines summary"||Seventeen years of post-licensure experience confirm confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers.||If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior|
vaccine containing tetanus toxoid, the decision to give INFANRIX should
be based on potential benefits and risks.For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with INFANRIX
|Encephalopathy within 7 days of administration of a previous pertussis-|
containing vaccine. Progressive neurologic disorders. Allergy to neomycin.
|Second dose MMR vaccine||VERO cell toxin-neutralizing test: diphtheria antitoxin concentration >0.01 IU/mL. In vivo mouse neutralization assay: tetanus antitoxin concentration >0.01 IU/mL||Pertussis vaccine efficacy (with DTaP) against >14 days of any cough or against paroxysmal cough was 73% (95% CI: 59, 82) and 84% (95% CI: 71, 91), respectively; "seroprotection" rates used for other vaccine components.||see data on individual vaccine components||2°C to 8°C||24 months||Chapter 28||
|Vaxelis||Sanofi||EMA||Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (recombinant), poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine (adsorbed).||pre-filled syringe||primary and booster vaccination of infants and toddlers from age > 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib)||two or three doses, >1 month apart as of 6 weeks of age.|
If a birth dose of hepatitis B vaccine was given, Vaxelis can be used for later doses of hepatitis B vaccine as of age >6 weeks. If a 2nd dose of hepatitis B vaccine is recommeneded before this age, monovalent hepatitis B vaccine should be used. Booster vaccination:
After a 2-dose or a 3-dose series, booster needed at least 6 months after last dose.
|Check "Vaccines summary". For rare side effects check product profile.||Check Vaccines Summmary||Caution needed in chilren with a history of fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine. Apnea following intramuscular vaccination observed in some infants born prematurely.||History of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized; a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause; history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.||Licence based on seroprotection achieved for the single components; see below||NA||see single components||2°C – 8°C||4 years||Chapter 28||
|Pediarix||GSK||FDA, (EMA: no longer authorised)||D, T, aP vaccine adsorbed, hepatitis B (recombinant) and IPV||color-coded, single-dose prefilled syringes||active immunization against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis||3-dose series in infants of hepatitis B surface antigen (HBsAg)-negative mothers given > 6 weeks through 6 years of age. Total of 4 doses of hepatitis B vaccine permitted if hepatitis B combination vaccine is administered after the birth dose||Check "Vaccines summary"||In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines||Check "Vaccines summary"||The efficacy of the pertussis component of PEDIARIX, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX.||NO DATA||The immune responses to all vaccine components were evaluated in sera obtained 1 month (range: 20 to 60 days) after the 3rd dose of PEDIARIX or INFANRIX. Adjusted GMCs / seroprotection rates in the PEDIARIX group were non-inferior to separately administered vaccines||The efficacy of the pertussis component of PEDIARIX, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX||2°C and 8°C||Chapter 28||
|Revac B||Bharat Biotech||WHO||Hepatitis-B (recombinant portein)||Suspension for injection in 05, 1 mL vials and pre-filled syringes||protects against hepatitks B, and in neonates, infants and young adults also from probable hepatitis B virus induced carrier state, cinrhosis and hepatic cellular carcinoma||Children: 1st dose at birth, 2nd dose 6 weeks of age, 3rd dose 14 weeks of age. Final dose administred < 24 weeks and > 16 weeks after 1st dose. Adults: Interval of 30 days between 1st and 2nd dose, followed by 3rd dose 180 days after first dose.||0.5 mL vial contain: HBsAG ≥10 µg; Al+++ 0.25 mg; Phosphate buffer saline q.s. to 0.5 mL. 1 mL vial contains: HBsAG≥ 20 µg; Al+++ 0.5 mg; Phosphate buffer saline q.s. to 1 mL||Check "Vaccines summary". For rare side effects check product profile.||Vaccines Summary||excerebration of multiple sclerosis has been reported||Hypersensitivity to vaccine components, severe febrile illness, multiple sclerosis, allergy to viral vaccines||Hib, BCG, polio, measles, mumps, rubella, diphteria, tetanus, influenza, pneumococcal vaccines (unlcear which). Should not be administred with HBIg.||see below||95.5%;||soley based on seroprtection, reach in clinical trials in 92% to 98% of recipients.||2°C to 8°C|
|Elovac-B||Indian Immunologicals Ltd||WHO?||Hepatitis-B (recombinant protein)||sterile suspension, ready to use for IM injections||prevention of infection hepatitis B||children < 15 years: 10 µg HBsAg 0.5mL suspension; >15 years: 20 µg HBsAg in 1mL suspension||0.5 mL vial contains: HBsAg ≥ 10 µg; Al+++ 0.25 mg; thiomersal 0.025 mg; phosphate buffer, saline q.s. to 0.5 mL. 1 mL vial contains: HBsAG ≥ 20 µg; Al+++ 0.5 mg;thiomersal 0.05 mg; Phosphate buffer, saline q.s. to 1 mL||Check "Vaccines summary". For rare side effects check product profile.||No specific safety concern.||The immune response may different by patient profile: age, smoking, obesity, ICH may have lower Ab titers.||Check "Vaccines summary".||with DPT, T, DT, OPV, MMR, Hib, HepA and BCG vaccines.||no data given||no data given||probably based on seroprotection rates||2 - 8°C||Chapter 37||