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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

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
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
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.
0264-410X
2300-2306
Marlow, Robin D.
3982ce7d-2555-4c3f-857c-bed14ef957cf
Kuriyakose, Sherine
ca031b53-7a66-425c-9f0d-455721724a84
Mesaros, Narcisa
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Han, Htay Htay
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Tomlinson, Richard
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Faust, Saul
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Snape, Matthew
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Pollard, Andrew
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Finn, Adam
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Marlow, Robin D.
3982ce7d-2555-4c3f-857c-bed14ef957cf
Kuriyakose, Sherine
ca031b53-7a66-425c-9f0d-455721724a84
Mesaros, Narcisa
4fd705cd-8098-4b2a-9811-542bca247fdf
Han, Htay Htay
10887bfa-c51a-432e-82c9-20e01f6fd601
Tomlinson, Richard
766f667a-ca8e-4fec-b1d8-bdc147e4215b
Faust, Saul
f97df780-9f9b-418e-b349-7adf63e150c1
Snape, Matthew
132c3c2d-eda6-4ee0-b853-356b08aa6488
Pollard, Andrew
6efdff46-9b02-4712-baf6-26d0168f56b4
Finn, Adam
59ac74fa-55a6-448d-9e19-9dd2f4654d4b

Marlow, Robin D., Kuriyakose, Sherine, Mesaros, Narcisa, Han, Htay Htay, Tomlinson, Richard, Faust, Saul, Snape, Matthew, Pollard, Andrew and Finn, Adam (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. (doi:10.1016/j.vaccine.2018.03.021).

Record type: Article

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.

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SRV_dTpa-IPV-009 primary_Vaccine 2018 - Accepted Manuscript
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More information

Accepted/In Press date: 9 March 2018
e-pub ahead of print date: 22 March 2018
Published date: 19 April 2018

Identifiers

Local EPrints ID: 418693
URI: http://eprints.soton.ac.uk/id/eprint/418693
ISSN: 0264-410X
PURE UUID: 93c28892-7ce5-4894-a34c-17fb793bae78
ORCID for Saul Faust: ORCID iD orcid.org/0000-0003-3410-7642

Catalogue record

Date deposited: 19 Mar 2018 17:30
Last modified: 26 Nov 2021 05:10

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Contributors

Author: Robin D. Marlow
Author: Sherine Kuriyakose
Author: Narcisa Mesaros
Author: Htay Htay Han
Author: Richard Tomlinson
Author: Saul Faust ORCID iD
Author: Matthew Snape
Author: Andrew Pollard
Author: Adam Finn

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