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Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization

NCT02712177 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4535

Last updated 2019-08-07

No results posted yet for this study

Summary

Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe, Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data showed that 4CMenB has a high reactogenicity especially when coadministered with other infant routine vaccines \[1-2\]. While this suggests that coadministration causes an interaction resulting in a greater risk of adverse events following Immunization (AEFI) only the AEFI after the 4CMenB dose and not those occurring after routine vaccine immunizations were reported, underestimating the total risk associated with immunization at separate visits. For financial and practical reasons, coadministration of infant vaccines is preferred to separate visits. Separate visits may however be preferred if the sum of the AEFI risk at each visit is significantly smaller than the risk with coadministration and/or if the AEFI has a lesser severity. The purpose of this study is to recalculate the risk of occurrence and severity of AEFI with the coadministration of Bexsero™ and routine vaccines compared to separate injections to assess the interaction occurring with co-administration. Investigators will also estimate the risk of recurrence of AEFI at subsequent immunizations with the 4CMenB and assess if this risk varies with separate or coadministration with routine vaccines. To achieve these purposes, investigators will perform a secondary analysis of the data of three randomized controlled trials (clinicaltrials.gov identifiers: NCT00657709, NCT00847145 and NCT00721396) that evaluated 5025 children aged 2 to 14 months of whom 4535 were randomized to receive 3 to 4 doses of 4CMenB concomitantly or alternatively with routine vaccinations (DTaP-Inactivated polio virus -HepatitisB/Haemophilus influenzae type b \[Infanrix Hexa™\], Pneumococcal conjugate vaccine, 7 valent \[Prevenar™\] or Measles-Mumps-Rubella-Varicella vaccine \[Priorix-Tetra™\]) \[1,2\].

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

4CMenb

BIOLOGICAL

diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB

BIOLOGICAL

conjugated pneumococcal vaccine

BIOLOGICAL

MMRV

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Canadian Immunization Research Network

    collaborator NETWORK

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Gaston De Serres, MD, PhD · CHU de Quebec

Eligibility

Min Age
2 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-08-31
Completion
2019-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712177 on ClinicalTrials.gov