Quinvaxem indications
Active primary and booster immunisation of infants and toddlers for protection against Diphtheria (Quinvaxem), Tetanus (Quinvaxem), Pertussis (Quinvaxem), Hepatitis B (Quinvaxem) and invasive illness caused by H. influenzae type b. Quinvaxem is indicated for infants regardless of whether or not they have received Hepatitis B (Quinvaxem) vaccination at birth. Based on available evidence and recommendations, it is concluded that Quinvaxem can, like similar combination vaccines, be used in infants interchangeably for basic immunisation with other DTP-HepB-Hib vaccines, or components thereof, as well as for boosting children primed in infancy with another combination vaccine.
Quinvaxem description
Each 0.5-mL dose of vaccine contains purified Diphtheria (Quinvaxem) toxoid not less than 7.5 Lf (not less than 30 IU), purified Tetanus (Quinvaxem) toxoid not less than 3.25 Lf (not less than 60 IU), inactivated B. Pertussis (Quinvaxem) not less than 15 OU (not less than 4 IU), Hib oligosaccharide 10 mcg conjugated to approximately 25 mcg of cross reacting material (CRM) 197, purified Hepatitis B (Quinvaxem) surface antigen 10 mcg, aluminium phosphate (adjuvant) 0.3 mg Al3+. It also contains the following excipients: Sodium chloride, water for injection to make 0.5 mL.
Quinvaxem contains aluminium phosphate as adjuvant, forming a whitish sediment.
Quinvaxem is free of preservatives. Thiomersal may be present in traces as a residue of the manufacturing process.
Quinvaxem is a ready-to-use, fully liquid combined vaccine containing Diphtheria (Quinvaxem) and Tetanus (Quinvaxem) toxoids, Bordetella Pertussis (Quinvaxem) inactivated cellular suspension, Hepatitis B (Quinvaxem) surface antigen (HBsAg) and Haemophilus influenzae type b conjugated oligosaccharide. The Diphtheria (Quinvaxem) and Tetanus (Quinvaxem) toxoids are obtained from Corynebacterium diphtheriae and Clostridium tetani cultures, respectively, by formaldehyde inactivation and purification. The Pertussis (Quinvaxem) suspension component is obtained from B. Pertussis (Quinvaxem) cultures after inactivation and purification. The HBsAg is produced in genetically engineered yeast cells (Hansenula polymorpha) carrying the relevant gene of the HBsAg. The antigen is purified and inactivated by several physicochemical steps. The H. influenzae type b component is made of purified capsular oligosaccharides conjugated to CRM 197, a nontoxic mutant of Diphtheria (Quinvaxem) toxin, prepared from C. diphtheriae cultures.
Quinvaxem dosage
Primary Vaccination: The primary vaccination consists of 3 doses of 0.5 mL to be administered at intervals of at least 4 weeks and as per schedule 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months.
All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks can be used whether or not a dose of Hepatitis B (Quinvaxem) vaccine has been given at birth.
Where a dose of Hepatitis B (Quinvaxem) vaccine is given at birth, Quinvaxem can be used for supplementary doses of Hepatitis B (Quinvaxem) vaccine from the age of 6 weeks. If a 2nd dose of Hepatitis B (Quinvaxem) vaccine is required before this age, monovalent Hepatitis B (Quinvaxem) vaccine should be used.
The use of Quinvaxem should be in accordance with official recommendations.
Booster Vaccination: After a 3-dose primary vaccination with Quinvaxem, a booster dose should be given, preferably during the 2nd year of life, at least 6 months after the last priming dose.
Booster doses should be given in accordance with the official recommendations. At the very least, a dose of Hib vaccine must be administered.
After a 3-dose primary vaccination with Quinvaxem (2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) and in the absence of Hepatitis B (Quinvaxem) vaccination at birth, it is necessary to give a Hepatitis B (Quinvaxem) vaccine booster dose. Quinvaxem can be considered for the booster.
After a 3-dose WHO EPI schedule with Quinvaxem (6, 10, 14 weeks) and in the absence of Hepatitis B (Quinvaxem) vaccination at birth, a Hepatitis B (Quinvaxem) vaccine booster must be given. At the very least, a booster dose of polio vaccine should be given. Quinvaxem can be considered for the booster.
When a Hepatitis B (Quinvaxem) vaccine is given at birth, after a 3-dose primary vaccination, Quinvaxem or a pentavalent DTaP/IPV/Hib vaccine can be administered for the booster.
Quinvaxem may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or pentavalent DTaP-IPV/Hib vaccine associated with a monovalent Hepatitis B (Quinvaxem) vaccine.
Administration: Immunisation must be carried out by IM injection. The recommended injection site is preferably the anterolateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months).
Quinvaxem interactions
Data on concomitant administration of Quinvaxem with a pneumococcal polysaccharide conjugated vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Data on concomitant administration of a booster dose of Quinvaxem with measles-mumps-rubella vaccines have shown no clinically relevant interference in the antibody response to each of the antigens. There may be a clinically relevant interference in the antibody response of Quinvaxem and a varicella vaccine and these vaccines should not be administered at the same time.
Data on concomitant administration of rotavirus vaccines have shown no clinically relevant interference in the antibody response to each of the antigens.
No data are available on concomitant administration of Quinvaxem with meningococcal vaccines.
If co-administration with another vaccine is considered, immunization should be carried out on separate injection sites.
Quinvaxem must not be mixed with any other vaccines or other parenterally administered medicinal products.
Except in the case of immunosuppressive therapy, no significant clinical interaction with other treatments or biological products has been reported.
Interference With Laboratory Testing: See Precautions.
Incompatibilities: In the absence of compatibility studies, Quinvaxem must not be mixed with other vaccines or medicinal products.
Quinvaxem side effects
Clinical Trial Adverse Reactions: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in practice. The adverse reaction information from clinical trials dose, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.
In a randomized, controlled clinical trial conducted in Canada, 339 infants were immunized with Quinvaxem at 2, 4 and 6 months. In addition, 301 of these children were immunized as toddlers at 18 months. Injection site reactions were generally mild. Up to 1/3 of children receiving Quinvaxem experienced some degree of redness, swelling or tenderness around in a injection site. The frequency of solicited injection site and systemic reactions observed in a clinical trial within 24 hrs of any dose of Quinvaxem given at 2, 4, 6 and 18 months are presented as follows: Very common: ≥10%; common: ≥1% and <10%.
Gastrointestinal Disorders: Common: Diarrhea, vomiting.
General Disorders and Administration Site Conditions: Very Common: Injection site tenderness, swelling, redness, fever (≥38°C), crying, eating less, fussiness, less active.
Data from Post-Marketing Experience: The following additional adverse events have been spontaneously reported during the post-marketing use of Quinvaxem worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Immune System Disorders: Hypersensitivity, anaphylactic reaction (eg, urticaria, angioedema).
Psychiatric Disorders: Irritability, screaming.
Nervous System Disorders: Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic-hyporesponsive episode (infant appears pale, hypotonic (limp) and unresponsive to parents). To date, this condition has not been associated with any permanent sequelae.
Vascular Disorders: Pallor.
Respiratory, Thoracic and Mediastinal Disorders: Apnea.
Skin and Subcutaneous Tissue Disorders: Erythema, rash. Musculoskeletal, Connective Tissue and Bone Disorders: General Disorders and Administration Site Conditions:
Large injection site reactions (>50 mm) including extensive limb swelling which may extend from the injection site beyond one or both joints, have been reported in children following Quinvaxem administration. These reactions usually start within 24-72 hrs after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. The risk appears to be dependent on the number of prior doses of acellular Pertussis (Quinvaxem) containing vaccine, with a greater risk following the 4th and 5th doses.
Edematous reactions affecting one or both lower limbs have occurred following vaccination with H. influenza type b containing vaccines. When this reaction occurs, it does so mainly after primary injections and is observed within the first few hours following vaccination. Associated symptoms may include cyanosis, redness, transient purpura and severe crying. All events resolved spontaneously without sequelae within 24 hours.
Quinvaxem contraindications
Hypersensitivity to Diphtheria (Quinvaxem), Tetanus (Quinvaxem), acellular Pertussis (Quinvaxem), Hepatitis B (Quinvaxem) (rDNA), inactivated Poliomyelitis (Quinvaxem) and adsorbed Hib conjugate vaccine or to any of the excipients of Quinvaxem, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any Pertussis (Quinvaxem) vaccine or after previous administration of Quinvaxem or a vaccine containing the same components or constituents.
History of an anaphylactic reaction after a previous administration of Quinvaxem.
Vaccination with Quinvaxem is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a Pertussis (Quinvaxem) containing vaccine (whole cell or acellular Pertussis (Quinvaxem) vaccines). In these circumstances, Pertussis (Quinvaxem) vaccination should be discontinued and the vaccination course should be continued with Diphtheria (Quinvaxem), Tetanus (Quinvaxem), Hepatitis B (Quinvaxem), Poliomyelitis (Quinvaxem) and Hib vaccines.
Pertussis (Quinvaxem) vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk.
Active ingredient matches for Quinvaxem:
Diphtheria/Tetanus/Pertussis/Hepatitis B/Poliomyelitis/Haemophilus Type b Conjugate Vaccine in Thailand.
Diphtheria Toxoid/Haemophilus B Conjugate Vaccine/Pertussis Toxoid/Tetanus Toxoid
| Unit description / dosage (Manufacturer) | Price, USD |
| Quinvaxem / vial 0.5 mL x 1's | $ 23.20 |
| Quinvaxem 0.5 mL x 50's | $ 1160.00 |
| QUINVAXEM 30IU/60IU INJECTION 1 vial / 1 ML injection each (Novartis India Ltd) | $ 10.48 |
| Quinvaxem vaccine / inj 0.5 mL x 1's (GlaxoSmithKline) | $ 31.11 |
| Quinvaxem vaccine / inj 0.5 mL x 50 x 1's (GlaxoSmithKline) | |
| Quinvaxem vaccine / vial 0.5 mL x 1's (Novartis Vaccines) | |
| QUINVAXEM 30IU/60IU INJECTION 1 vial / 0.5 ML injection each (Novartis India Ltd) | $ 10.48 |
| Quinvaxem Injection (Novartis India Ltd) | $ 10.48 |
List of Quinvaxem substitutes (brand and generic names): | |
| COMVAC (India) | |
| COMVAC inj 0.5ml (Bharat Biotech) | $ 7.23 |
| Comvac 3+ BioHib Combipack (Bharat Biotech) | $ 5.42 |
| Diphtheria Toxoid/Haemophilus B Conjugate Vaccine/Pertussis Toxoid/Tetanus Toxoid | |
| diphtheria toxoid/haemophilus influenzae type b oligosaccharide/hepatitis B surface antigen/inactivated whole cell bordetella pertussis vaccine/tetanus toxoid (India) | |
| Diphtheria/Tetanus/Pertussis/Hepatitis B/Poliomyelitis/Haemophilus Type b Conjugate Vaccine (Austria, Belgium, Bosnia & Herzegowina, Canada, Chile, Croatia (Hrvatska), Czech Republic, Denmark, France, Germany, Ireland, Italy, Myanmar, Poland, Romania, Singapore, Slovakia, Spain, Sweden, Thailand) | |
| Easy Six Vaccine | |
| Easy Six Vaccine (Panacea Biotec Ltd) | $ 28.83 |
| Easyfour-TT Paediatric Vaccine | |
| Easyfour-TT Paediatric Vaccine (Panacea Biotec Ltd) | $ 7.47 |
| Haemophilus b oligosaccharide/inactivated pertussis not <15 OU/Purified diphtheria toxoid not <75 Lf/purified HBsAg/purified tetanus toxoid not <325 Lf (Philippines) | |
| HEXAXIM (Bosnia & Herzegowina, Malaysia, Myanmar, Thailand) | |
| Hexaxim vaccine / inj 0.5 mL 1's (Sanofi Pasteur) | |
| Hexaxim vaccine / inj 0.5 mL x 1's (Sanofi Pasteur) | |
| Hexaxim vaccine / inj / pre-filled syringe 0.5 mL x 1's (Sanofi Pasteur) | |
| Hexaxim Vaccine (Sanofi Pasteur) | $ 57.83 |
| Infanrix Tetra (France) | |
| Injectable; Injection; Diphtheria, Tetanus, Pertussis, Poliomyelitis Vaccine (Gsk) | |
| InfanrixQuinta (France) | |
| Injectable; Injection; Bordetella Pertussis Antigens 58 mcg; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella pertussis 25 mcg; Haemophilus Influenzae Type B Polysaccharide 10 mcg; Pertactin 8 mcg; Poliomy (Gsk) | |
| Injectable; Injection; Bordetella Pertussis Antigens 58 mcg; Bordetella Pertussis Toxoid 25 mcg; Diphtheria Toxoid 30 IU; Filamentous Haemagglutinin Bordetella pertussis 25 mcg; Haemophilus Influenzae Type B Polysaccharide 10 mcg; Pertactin 8 mcg; Poliomy (Gsk) | |
| Pediacel (Croatia (Hrvatska), Czech Republic) | |
| Injectable; Injection; Diphtheria Toxoid 15 LF; Filamentous Haemagglutinin 20 mcg; Fimbriae 5 mcg; Haemophilus Influenzae Type B-PRP 10 mcg; Poliomyelitis Vaccine Inactivated / D.C.O. Type 1 Mahoney 40 units; Poliomyelitis Vaccine Inactivated / D.C.O. Typ (sanofi pasteur) | |
| Pediacel / pre-filled syringe 0.5 mL (sanofi pasteur) | |
| Pediacel / vial 1's (sanofi pasteur) | |
| Pediacel / vial; 1 dose 0.5 mL (sanofi pasteur) | |
| Pediacel 0.5 mL (sanofi pasteur) | |
| Pediacel 0.5 mL x 1's (sanofi pasteur) | |
| Pediacel / pre-filled syringe 0.5 mL x 1's (sanofi pasteur) | |
| Injectable; Injection; Diphtheria Toxoid 15 LF; Filamentous Haemagglutinin 20 mcg; Fimbriae 5 mcg; Haemophilus Influenzae Type B-PRP 10 mcg; Poliomyelitis Vaccine Inactivated / D.C.O. Type 1 Mahoney 40 units; Poliomyelitis Vaccine Inactivated / D.C.O. Typ (sanofi pasteur) | |
| Pediacel vaccine inj / vial 0.5 mL x 1's (sanofi pasteur) | |
| Pentaxim (Colombia, Latvia, Turkey) | |
| Pentaxim / pre-filled syringe 0.5 mL x 1's (Sanofi Pasteur) | |
| Pentaxim 1 Bottle boät 1 lieà u Act-Hib in bôm tieâm 1 lieà u DTacP-IPV 0.5 mL (Sanofi Pasteur) | |
| 0.5ml (Sanofi Pasteur) | $ 24.89 |
| Pentaxim / vial + 0.5 mL pre-filled syringe 1's (Sanofi Pasteur) | $ 42.00 |
| PENTAXIM INJECTION 1 vial / 0.5 ML injection each (Sanofi Pasteur) | $ 30.06 |
| Pentaxim vaccine / inj / vial + pre-filled syringe / 0.5 mL 2's (Sanofi Pasteur) | $ 42.00 |
| Pentaxim vaccine / inj / / vial + pre-filled syringe 0.5 mL x 2's (Sanofi Pasteur) | |
| Pentaxim vaccine / pre-filled syringe / + 1 vial / lyophilised powd 0.5 mL x 2's (Sanofi Pasteur) | |
| PENTAXIM inj 0.5ml (Sanofi Pasteur) | $ 22.81 |
| Pentaxim vaccine / inj / Vial + Pre-filled syringe 0.5 mL x 2's (Sanofi Pasteur) | |
| Pentaxim vaccine / inj 0.5 mL x 2's (Sanofi Pasteur) | |
| QUADROVAX | |
| QUADROVAX INJECTION 1 vial / 1 ML injection each (Serum Institute Of India Ltd) | $ 5.17 |
| Shan5 (Georgia) | |
| Tritanrix HB+Hiberix (Chile) | |
References
- PubChem. "Tetanus toxoid". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
- DrugBank. "Clostridium tetani toxoid antigen (formaldehyde inactivated) - DrugBank". http://www.drugbank.ca/drugs/DB10583 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Quinvaxem are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Quinvaxem. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
