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 p...
| Main Authors: | , , , , , , , , , , |
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| Format: | Journal article |
| Sprog: | English |
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2008
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| _version_ | 1826291279565160448 |
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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 stage 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 >or=1:128 and 100% (LL 95% CI 99.2) achieved anti-PRP concentrations >or=1.0 microg/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. TRIAL REGISTRATION NUMBER: NCT00258700. Study ID: 103974 (http://clinicaltrials.gov). |
| first_indexed | 2024-03-07T02:57:03Z |
| format | Journal article |
| id | oxford-uuid:aface1e3-e4e2-4af6-85f9-9e5f18875d1b |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T02:57:03Z |
| publishDate | 2008 |
| record_format | dspace |
| spelling | oxford-uuid:aface1e3-e4e2-4af6-85f9-9e5f18875d1b2022-03-27T03:51:01ZA novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:aface1e3-e4e2-4af6-85f9-9e5f18875d1bEnglishSymplectic Elements at Oxford2008Pace, DSnape, MWestcar, SOluwalana, CYu, LBegg, NWysocki, JCzajka, HMaechler, GBoutriau, DPollard, A 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 stage 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 >or=1:128 and 100% (LL 95% CI 99.2) achieved anti-PRP concentrations >or=1.0 microg/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. TRIAL REGISTRATION NUMBER: NCT00258700. Study ID: 103974 (http://clinicaltrials.gov). |
| spellingShingle | 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 |
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