Combination Vaccines

Decker, Michael D.; Edwards, Kathryn M.; Howe, Barbara J.

doi:10.1016/b978-0-323-35761-6.00015-8

Cited by 12 publications

(2 citation statements)

References 329 publications

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“…Diphtheria, tetanus, pertussis (DTP) combination vaccines were first introduced in 1948 [ 1 ]. Since several decades, they have been the cornerstone of immunization programs to vaccinate infants and children.…”

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants–A randomized study

et al. 2023

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Background Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components. Methods This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6–8, 10–12 and 14–16 weeks of age. Results The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune responses (adjusted geometric mean concentrations of antibodies for anti-PT were 76.7 EU/mL versus 63.3 EU/mL, with a ratio of aGMTs of 1.21 (95% CI, 0.89–1.64), and for anti-FIM were 1079 EU/mL versus 1129 EU/mL, with a ratio of aGMTs of 0.95 (95% CI, 0.73–1.24), respectively). The immune responses to other valences (D, T, and Hib) in the two formulations were also similar. The safety profile of both formulations was found to be similar and were well tolerated. Conclusions The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. Clinical trial registration Clinical Trials Registry India number: CTRI/2018/12/016692.

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Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants–A randomized study

et al. 2023

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“…Finally, almost all wP-and aP-containing vaccines are administered in combination with diphtheria and tetanus toxoids, but in many cases they are also combined with polyribosylribitol phosphate from Haemophilus influenzae type b (Hib), inactivated poliovirus, or the hepatitis B virus surface antigen (HBsAg). In considering interchangeability, possible effects for all vaccine antigens have to be taken into account (Decker et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

Pertussis vaccination in mixed markets: Recommendations from the Global Pertussis Initiative

Chitkara

Ferrer

Forsyth

et al. 2020

International Journal of Infectious Diseases

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The Global Pertussis Initiative is an expert scientific forum that publishes consensus recommendations concerning pertussis for many regions of the world. Here, we give recommendations for the primary vaccination of infants in those countries where whole-cell pertussis (wP)-and acellular pertussis (aP)containing combination vaccines are used in parallel. A selective literature review was performed concerning the influence on safety, immunogenicity, and effectiveness of mixing wP-and aP-containing vaccines for primary immunization of infants. In addition, local data were collected from various countries and the results discussed in a face-to-face meeting. Very few data addressing issues of mixing combination vaccines were identified, and no data were available concerning the effectiveness or duration of protection. It was also found that pharmacovigilance data are scarce or lacking in those countries where they would be needed the most. We then identified frequent problems occurring in lowand middle-income countries (LMICs) where both vaccine types are used. Relying on local knowledge, we give practical recommendations for a variety of situations in different settings. Specific needs for additional data addressing these issues were also identified. International bodies, such as the World Health Organization (WHO), as well as vaccine producers should try to find ways to highlight the problems of mixing wP-and aP-containing combination vaccines with robust data. Countries are urged to improve on their pharmacovigilance for vaccines. For practicing physicians, our recommendations offer guidance when wP-and aP-containing vaccines are used in parallel during primary immunization.

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Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama

Juliao¹,

Abadia

Welby

et al. 2021

Vaccine

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Combination Vaccines

Cited by 12 publications

References 329 publications

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants–A randomized study

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants–A randomized study

Pertussis vaccination in mixed markets: Recommendations from the Global Pertussis Initiative

Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama

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