A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK

Robin Marlow; Sherine Kuriyakose; Narcisa Mesaros; Htay Htay Han; Richard Tomlinson; Saul N. Faust; Matthew D. Snape; Andrew J. Pollard; Adam Finn

doi:10.1016/j.vaccine.2018.03.021

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK

Robin Marlow^*, Sherine Kuriyakose, Narcisa Mesaros, Htay Htay Han, Richard Tomlinson, Saul N. Faust, Matthew D. Snape, Andrew J. Pollard, Adam Finn

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

Aim: To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPV_B) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPV_R (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV). Methods: This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPV_B or dTap-IPV_R) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPV_B vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated. Results: 387 children were randomised and 385 vaccinated: 255 in the dTap-IPV_B group and 130 in the dTap-IPV_R group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPV_B group. Conclusion: Non-inferiority of dTap-IPV_B to dTap-IPV_R was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 (ClinicalTrials.gov)

Original language	English
Pages (from-to)	2300-2306
Number of pages	7
Journal	Vaccine
Volume	36
Issue number	17
Early online date	22 Mar 2018
DOIs	https://doi.org/10.1016/j.vaccine.2018.03.021
Publication status	Published - 19 Apr 2018

Keywords

Preschool booster
dTap-IPV
RCT
Child
UK

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Marlow, R., Kuriyakose, S., Mesaros, N., Han, H. H., Tomlinson, R., Faust, S. N., Snape, M. D., Pollard, A. J., & Finn, A. (2018). A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. Vaccine, 36(17), 2300-2306. https://doi.org/10.1016/j.vaccine.2018.03.021

Marlow, Robin ; Kuriyakose, Sherine ; Mesaros, Narcisa et al. / A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. In: Vaccine. 2018 ; Vol. 36, No. 17. pp. 2300-2306.

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title = "A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK",

abstract = "Aim: To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPVR (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV). Methods: This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPVB vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated. Results: 387 children were randomised and 385 vaccinated: 255 in the dTap-IPVB group and 130 in the dTap-IPVR group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPVB group. Conclusion: Non-inferiority of dTap-IPVB to dTap-IPVR was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 (ClinicalTrials.gov)",

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author = "Robin Marlow and Sherine Kuriyakose and Narcisa Mesaros and Han, {Htay Htay} and Richard Tomlinson and Faust, {Saul N.} and Snape, {Matthew D.} and Pollard, {Andrew J.} and Adam Finn",

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doi = "10.1016/j.vaccine.2018.03.021",

language = "English",

volume = "36",

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journal = "Vaccine",

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Marlow, R, Kuriyakose, S, Mesaros, N, Han, HH, Tomlinson, R, Faust, SN, Snape, MD, Pollard, AJ & Finn, A 2018, 'A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK', Vaccine, vol. 36, no. 17, pp. 2300-2306. https://doi.org/10.1016/j.vaccine.2018.03.021

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. / Marlow, Robin; Kuriyakose, Sherine; Mesaros, Narcisa et al.
In: Vaccine, Vol. 36, No. 17, 19.04.2018, p. 2300-2306.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

TY - JOUR

T1 - A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK

AU - Marlow, Robin

AU - Kuriyakose, Sherine

AU - Mesaros, Narcisa

AU - Han, Htay Htay

AU - Tomlinson, Richard

AU - Faust, Saul N.

AU - Snape, Matthew D.

AU - Pollard, Andrew J.

AU - Finn, Adam

PY - 2018/4/19

Y1 - 2018/4/19

N2 - Aim: To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPVR (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV). Methods: This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPVB vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated. Results: 387 children were randomised and 385 vaccinated: 255 in the dTap-IPVB group and 130 in the dTap-IPVR group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPVB group. Conclusion: Non-inferiority of dTap-IPVB to dTap-IPVR was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 (ClinicalTrials.gov)

AB - Aim: To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPVB) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3–4 year old children as compared to dTap-IPVR (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV). Methods: This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPVB or dTap-IPVR) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPVB vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated. Results: 387 children were randomised and 385 vaccinated: 255 in the dTap-IPVB group and 130 in the dTap-IPVR group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2–100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPVB group. Conclusion: Non-inferiority of dTap-IPVB to dTap-IPVR was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3–4 years old. Trial registration: NCT01245049 (ClinicalTrials.gov)

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KW - RCT

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KW - UK

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U2 - 10.1016/j.vaccine.2018.03.021

DO - 10.1016/j.vaccine.2018.03.021

M3 - Article (Academic Journal)

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SN - 0264-410X

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Marlow R, Kuriyakose S, Mesaros N, Han HH, Tomlinson R, Faust SN et al. A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK. Vaccine. 2018 Apr 19;36(17):2300-2306. Epub 2018 Mar 22. doi: 10.1016/j.vaccine.2018.03.021