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CompletedNCT02712177Updated Aug 7, 2019

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

An observational study in Meningococcal Infections, sponsored by CHU de Quebec-Universite Laval. Completed. Open to participants aged 2 Months to 14 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by CHU de Quebec-Universite Laval · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
4,535
Ages
2 Months to 14 Months
Sex
All
01

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].

02

Conditions studied

  • Meningococcal Infections

Keywords

  • vaccine safety
  • interaction
03

In context

Meningococcal Infections

225 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.

This study's enrollment of 4,535 is above the median of 116 across 27 observational studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.

Browse CHU de Quebec-Universite Laval studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 14 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy children aged 2 to 14 months selected to participate in clinical trials assessing the safety and immunogenicity of 4 component meningococcal serogroup B vaccine (4CMenB) in Austria, Belgium, Czech Republic, Finland, Germany, Italy, Spain, United Kingdom.

Eligibility criteria

Inclusion Criteria:

  • Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks
  • Parent/legal guardian has given written informed consent after the nature of the study has been explained.

Main exclusion Criteria :

  • History of any meningococcal B or C vaccine administration; prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
  • Previous ascertained or suspected disease caused by N. meningitidis; History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
  • Antibiotics within 6 days prior to enrollment;
  • Any serious chronic or progressive disease;
  • Known or suspected impairment or alteration of the immune system;
  • Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
4,535 participants (actual)
Patient registry
No

Groups and cohorts

  • Coadministration B_RV246

    Subjects in this group received 4CMenB vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations (Infanrix Hexa+Prevenar).

    Biological: 4CMenb · Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine

  • Coadministration B_RV234

    Subjects in this group received 4CMenB vaccine at 2, 3 and 4 months of age, administered concomitantly with routine infant vaccinations (Infanrix Hexa+Prevenar)..

    Biological: 4CMenb · Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine

  • Coadministration B_MMRV12

    Subjects in this group previously received three doses of 4CMenB and routine vaccine at 2, 4 and 6 months of age,respectively. They also received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.

    Biological: 4CMenb · Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine · Biological: MMRV

  • Separate administration B246_RV357

    Subjects in this group received 4CMenB vaccine at 2, 4, and 6 months of age; routine infant vaccinations (Infanrix Hexa+Prevenar) were administered at 3, 5 and 7 months of age.

    Biological: 4CMenb · Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine

  • Separate administration B12_MMRV13

    Subjects in this group previously received three doses of 4CMenB and routine vaccines (Infanrix Hexa+Prevenar) at 2, 4 and 6 months of age. They also received a booster (fourth) dose of 4CMenB at 12 months of age and one dose of MMRV vaccine at 13 months of age.

    Biological: 4CMenb · Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine · Biological: MMRV

  • Routine vaccines only at 2, 3 and 4 months of age (RV234)

    Subjects in this group received routine infant vaccines (Infanrix Hexa+Prevenar) at 2, 3 and 4 months of age.

    Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine

  • Routine vaccines only at 2, 4 and 6 months of age.(RV246)

    Subjects in this group received routine infant vaccines (Infanrix Hexa+Prevenar) at 2, 4 and 6 months of age.

    Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB · Biological: conjugated pneumococcal vaccine

Interventions

06

What researchers measure

Primary outcomes

  1. Fever

    Temperature ≥ 38°C

    Time frame: AT RISK INTERVAL 4CMenB and inactivated routine vaccines (InRV) : Onset 24 hours following immunization (post-Imm). MMRV: Onset day 5 to day 13 post-Imm.CONTROL INTERVAL 4CMenB and InRV : Onset day 4 to 7post-Imm . MMRV: Onset day 0 to 4 post-Imm

  2. Systemic reactions other than fever

    systemic signs/symptoms (e.g. change in eating habits, sleepiness, unusual crying, vomiting, diarrhea, irritability…) without signs of localized infection (respiratory, urinary, etc...).

    Time frame: AT RISK INTERVAL 4CMenB and InRV : Onset 24 hours post-Imm. MMRV: Onset day 5 to day 13 post-Imm.CONTROL INTERVAL 4CMenB and InRV : Onset day 4 to 7post-Imm . MMRV: Onset day 0 to 4 post-Imm

  3. Fever or systemic reactions other than fever

    all systemic signs/symptoms including fever (Temperature ≥ 38°C)

    Time frame: AT RISK INTERVAL 4CMenB and InRV : Onset 24 hours post-Imm. MMRV: Onset day 5 to day 13 post-Imm.CONTROL INTERVAL 4CMenB and InRV : Onset day 4 to 7post-Imm . MMRV: Onset day 0 to 4 post-Imm

  4. Injection site reactions

    Time frame: AT RISK INTERVAL all injection site reactions regardless of their delay of onset. Baseline (CONTROL) risk null.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012 Feb 8;307(6):573-82. doi: 10.1001/jama.2012.85. PubMed 22318278 ↗
  • Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8. PubMed 23324563 ↗
  • Baker MA, Lieu TA, Li L, Hua W, Qiang Y, Kawai AT, Fireman BH, Martin DB, Nguyen MD. A vaccine study design selection framework for the postlicensure rapid immunization safety monitoring program. Am J Epidemiol. 2015 Apr 15;181(8):608-18. doi: 10.1093/aje/kwu322. Epub 2015 Mar 13. PubMed 25769306 ↗
  • Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953. PubMed 31110098 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02712177
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
GlaxoSmithKline, Canadian Immunization Research Network
Responsible party
Gaston De Serres (Researcher, MD, PhD, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Mar 18, 2016
Start date
Aug 2008
Primary completion
Aug 2010
Completion
Apr 2019
Last update
Aug 7, 2019

Study contacts

Gaston De Serres, MD, PhD
principal investigator · CHU de Quebec

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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