DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure.

Introduction: Hexaxim® is fully liquid, hexavalent, combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency.

Areas Covered: Safety and immunogenicity data were reviewed from >25 clinical trials involving approximately 7200 infants/toddlers, identified using PubMed searches to April 2023.

Vaccination in pregnancy against pertussis and seasonal influenza: key learnings and components from high-performing vaccine programmes in three countries: the United Kingdom, the United States and Spain.

Background: Pertussis and seasonal influenza are responsible for significant maternal, neonatal, and infant morbidity and mortality, but vaccine coverage rates (VCR) for both pertussis (administered as a tetanus, diphtheria, acellular pertussis [Tdap] vaccination) and seasonal influenza in pregnancy remain generally low. Only a small number of countries, including Spain, the United Kingdom (UK), and the United States (US), have high Tdap and seasonal influenza VCRs in pregnancy. The purpose of this study was to identify the key factors that contributed to the high VCRs observed in these countries.

Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series.

Background: Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants.

Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers.

Invasive meningococcal disease caused by Neisseria meningitidis is a life-threatening disease. Several countries now include meningococcal serogroup C (MenC) conjugate and, more recently, a meningococcal serogroup ACWY conjugate (MenACWY) vaccination in their national immunization schedules. DTaP-IPV-HB-PRP-T is a hexavalent vaccine that provides protection against six diseases.

Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib).

DTaP5-IPV-HB-Hib vaccine is a fully-liquid, combination hexavalent vaccine. This phase III, open-label, multicentre study conducted in Spain, evaluated the immune response to all DTaP5-IPV-HB-Hib antigens when the vaccine was used in a mixed hexa/penta/hexa primary series. Infants (who had received one dose of hepatitis B vaccine at birth) received a mixed schedule including DTaP5-IPV-HB-Hib (PRP-OMP conjugate) at 2 and 6months of age, DTaP5-IPV-Hib at 4months, meningococcal serogroup C conjugate (MCC) vaccine at 2 and 4months, and routine rotavirus and pneumococcal vaccination.

DTaP5-IPV-Hib-HepB, a hexavalent vaccine for infants and toddlers.

Combination vaccines reduce the 'shot burden' and simplify the childhood immunization schedule. Only 5-valent DTaP-based vaccines are licensed in the U.S.

Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants.

DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants. This was a phase III, open-label, randomised, multicentre study conducted in Finland.

A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months.

Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. Diphtheria-tetanus toxoids-acellular pertussis 5, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b (DTaP5-HB-IPV-Hib) is a new investigational, fully liquid, combination vaccine containing a 5-antigen pertussis component and is designed to protect against 6 infectious diseases.

Methods: In this multicenter, double-blind, comparator-controlled, phase III study (NCT01341639) conducted in Finland, Germany and Belgium, healthy infants were randomized 1:1 to receive 1 of 2 immunization regimens.

A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months.

Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational, fully-liquid, combination vaccine designed to protect against 6 infectious diseases, including 5 pertussis antigens and OMPC instead of PT as conjugated protein for Hib component.

Methods: In this multicenter, double-blind, comparator-controlled, Phase III study (NCT01480258) conducted in Sweden, Italy, and Finland, healthy infants were randomized 1:1 to receive one two immunization regimens.

Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age.

This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response.

Immunogenicity and safety of fully liquid DTaP₅-IPV-Hib compared with DTaP₃-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study.

This study compared immunogenicity and safety of DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib coadministered with PCV7 at 2, 3, and 4 months (primary series) and a fourth-dose booster at 12-18 months of age. Seroprotection rates for DTaP(5)-IPV-Hib were high (noninferior to DTaP(3)-IPV/Hib for the primary series) for antigens common to both vaccines and PCV7 antigens. Geometric mean concentration (GMC) for Hib antibodies were higher in the DTaP(5)-IPV-Hib group than the DTaP(3)-IPV/Hib group after the primary series and booster dose; GMCs or titers for other antigens were generally similar between groups after the primary series and booster dose.

Antibody persistence in UK pre-school children following primary series with an acellular pertussis-containing pentavalent vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine.

This open-label, randomised, controlled study examined antibody persistence following infant vaccination at 2, 3 and 4 months of age with either an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Haemophilus influenzae type b (DT(5)aP-IPV-Hib; Pediacel) or a whole-cell pertussis (DTwP//Hib+oral poliomyelitis vaccine [OPV]) combination vaccine, given concomitantly with meningococcal serogroup C conjugate (MCC) vaccine, followed by a Hib booster at approximately 15 months of age. Immune responses were sustained to 3.5-4.

Immunogenicity and reactogenicity of a combined adsorbed tetanus toxoid, low dose diphtheria toxoid, five component acellular pertussis and inactivated polio vaccine in six-year-old children.

Background: The objective of this study was to assess the immunogenicity and reactogenicity of the combined adsorbed tetanus toxoid, low dose diphtheria toxoid, 5-component acellular pertussis and inactivated polio vaccine (TdcP-IPV) as compared with a pediatric dose diphtheria formulation, combined with adsorbed tetanus toxoid and 3-component acellular pertussis (DTacP), in 6-year-old children who were immunized with 4 doses of diphtheria-tetanus-whole cell cellular pertussis (DTwcP) plus oral polio vaccine (OPV) before 2 years of age, according to the local Spanish vaccination calendar.

Methods: One hundred ninety-four healthy 6-year-old children were randomized to receive 1 dose of TdcP-IPV or 1 dose of DTacP and OPV.

Results: One month postvaccination, antidiphtheria and antitetanus titers were > or =0.

Antibody persistence against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) in 5-6-year-old children after primary vaccination and first booster with a pentavalent combined acellular pertussis vaccine: immunogenicity and tolerance of a tetravalent combined acellular pertussis vaccine given as a second booster.

Unlabelled: The main objective of this study was to assess in 5-6-year-old French children (n=234) the persistence of antibodies induced by a primary series vaccination (at 2-4 months of age) and a first booster (at 12-16 months of age) with a pentavalent two-component acellular pertussis combined vaccine (DTacP-IPV-Hib; Pentavac). The second objective was to evaluate in these 5-6-year-old French children the safety and the immunogenicity of a tetravalent acellular pertussis combined vaccine (DTacP-IPV; Tetravac) given as second booster.

Results: Seroprotective antibody levels against diphtheria, tetanus, types 1-3 poliomyelitis and PRP were maintained 4-5 years after primary-vaccination and first booster with Pentavac.

Persistence of antibodies at 5-6 years of age for children who had received a primary series vaccination with a pentavalent whole-cell pertussis vaccine and a first booster with a pentavalent acellular pertussis vaccine: immunogenicity and tolerance of second booster with a tetravalent acellular vaccine at 5-6 years of age.

Unlabelled: The main objective of this study was to assess in 5-6-year-old French children (n=162) the persistence of antibodies induced by a primary series vaccination (at 2-4 months of age) with a pentavalent whole-cell pertussis combined vaccine (DTwcP-IPV-Hib; Pentacoq) and a first booster (at 12-16 months of age) with a pentavalent two-component acellular pertussis combined vaccine (DTacP-IPV-Hib; Pentavac). The second objective was to evaluate in these 5-6-year-old French children the safety and the immunogenicity of a tetravalent pertussis combined vaccine (DTacP-IPV, Tetravac) given as a second booster.

Results: before the 2nd booster, more than 90% of children had antibody titers above the defined threshold for polyribosyl ribitol phosphate (PRP), tetanus, diphtheria and poliomyelitis; antibody titers were very low for pertussis.