A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial
Objective: To study the immunogenicity and reactogenicity of a combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) when administered as a booster dose in combination with a measles, mumps and rubella vaccine (MMR). Design: A ph...
| Main Authors: | , , , , , , , , , , |
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| 格式: | Journal article |
| 語言: | English |
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BMJ Publishing Group
2008
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| 主題: |
| _version_ | 1826261027943088128 |
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| author | Pace, D Snape, M Westcar, S Oluwalana, C Yu, L Begg, N Wysocki, J Czajka, H Maechler, G Boutriau, D Pollard, A |
| author_facet | Pace, D Snape, M Westcar, S Oluwalana, C Yu, L Begg, N Wysocki, J Czajka, H Maechler, G Boutriau, D Pollard, A |
| author_sort | Pace, D |
| collection | OXFORD |
| description | Objective: To study the immunogenicity and reactogenicity of a combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) when administered as a booster dose in combination with a measles, mumps and rubella vaccine (MMR). Design: A phase 3 open randomised controlled trial. Setting: One centre in Oxford, Uk and nine centres in Poland. Subjects: 12-15-month-old healthy children. Interventions: In the primary state of the study 500 healthy 6-12-week-old infants were randomised in a 3:1 ratio to receive Hib-MenC-TT+DTPa-IPV or MenC-CRM197 vaccine+DTPa-IPV-Hib. In the booster stage, 476 participants (190 in the UK and 286 in Poland) were vaccinated with Hib-MenC-TT and MMR. Main outcome measures: The proportion of children with protective serum antibody levels against MenC and Hib 6 weeks following a Hib-MenC-TT booster dose. Results: The co-primary objectives were met: the Hib-MenC-TT booster dose induced protective antibody titres in children vaccinated with Hib-MenC-TT+DTPa-IPV or MenC-CRM197+DTPa-IPV-Hib at 2, 3 and 4 months of age. 94.8% (lower limit of (LL) 95% CI 92.4) of participants had rSBA-MenC ≥1:128 and 100% (LL95% CI 99.2) achieved anti-PRP concentrations ≥ 1.0 μg/ml. The percentage of toddlers with a post boost rSBA-MenC of 1:128 was significantly higher after priming with Hib-MenC-TT (97.7%) than after MenC-CRM197 (86%) difference: 11.7%; 95% CI 6.2 to 19.4). Conclusion: The waning antibody titres against Hib and MenC following primary immunisation can be boosted to protective levels by administering the Hib-MenC-TT vaccine at 12-15 months of age, supporting the recent introduction of this vaccine in the UK immunisation schedule to sustain protection of children against Hib and MenC disease. |
| first_indexed | 2024-03-06T19:15:05Z |
| format | Journal article |
| id | oxford-uuid:180f47fd-9277-4b1d-a7e5-d13f038df2da |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T19:15:05Z |
| publishDate | 2008 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:180f47fd-9277-4b1d-a7e5-d13f038df2da2022-03-26T10:41:16ZA novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:180f47fd-9277-4b1d-a7e5-d13f038df2daVaccinologyMedical sciencesPaediatricsEnglishOxford University Research Archive - ValetBMJ Publishing Group2008Pace, DSnape, MWestcar, SOluwalana, CYu, LBegg, NWysocki, JCzajka, HMaechler, GBoutriau, DPollard, AObjective: To study the immunogenicity and reactogenicity of a combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) when administered as a booster dose in combination with a measles, mumps and rubella vaccine (MMR). Design: A phase 3 open randomised controlled trial. Setting: One centre in Oxford, Uk and nine centres in Poland. Subjects: 12-15-month-old healthy children. Interventions: In the primary state of the study 500 healthy 6-12-week-old infants were randomised in a 3:1 ratio to receive Hib-MenC-TT+DTPa-IPV or MenC-CRM197 vaccine+DTPa-IPV-Hib. In the booster stage, 476 participants (190 in the UK and 286 in Poland) were vaccinated with Hib-MenC-TT and MMR. Main outcome measures: The proportion of children with protective serum antibody levels against MenC and Hib 6 weeks following a Hib-MenC-TT booster dose. Results: The co-primary objectives were met: the Hib-MenC-TT booster dose induced protective antibody titres in children vaccinated with Hib-MenC-TT+DTPa-IPV or MenC-CRM197+DTPa-IPV-Hib at 2, 3 and 4 months of age. 94.8% (lower limit of (LL) 95% CI 92.4) of participants had rSBA-MenC ≥1:128 and 100% (LL95% CI 99.2) achieved anti-PRP concentrations ≥ 1.0 μg/ml. The percentage of toddlers with a post boost rSBA-MenC of 1:128 was significantly higher after priming with Hib-MenC-TT (97.7%) than after MenC-CRM197 (86%) difference: 11.7%; 95% CI 6.2 to 19.4). Conclusion: The waning antibody titres against Hib and MenC following primary immunisation can be boosted to protective levels by administering the Hib-MenC-TT vaccine at 12-15 months of age, supporting the recent introduction of this vaccine in the UK immunisation schedule to sustain protection of children against Hib and MenC disease. |
| spellingShingle | Vaccinology Medical sciences Paediatrics Pace, D Snape, M Westcar, S Oluwalana, C Yu, L Begg, N Wysocki, J Czajka, H Maechler, G Boutriau, D Pollard, A A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title | A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title_full | A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title_fullStr | A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title_full_unstemmed | A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title_short | A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial |
| title_sort | novel combined hib menc tt glycoconjugate vaccine as a booster dose for toddlers a phase 3 open randomised controlled trial |
| topic | Vaccinology Medical sciences Paediatrics |
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