Skip to main content
OpenTrials
Completed

NCT Number: NCT02712177

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

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].

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Meningococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Neisseriaceae Infections

Age range

2 month–14 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4CMenB

Biological

Other names: Bexsero

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

Biological

Other names: Infanrix Hexa

conjugated pneumococcal vaccine

Biological

Other names: Prevenar

MMRV

Biological

Other names: Priorix Tetra

Primary outcomes

  1. Fever

    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

    Temperature ≥ 38°C

  2. Systemic reactions other than fever

    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

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

  3. Fever or systemic reactions other than fever

    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

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

  4. Injection site reactions

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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Immunization Research Network
  • GlaxoSmithKline

Registry information

Official study title

Interaction Between Meningococcal Serogroup B Vaccine (Bexsero™) and Routine Infant Vaccines on the Risk of Occurrence and Recurrence of Adverse Events Following Immunization.

Important dates

Study start
2008
Primary completion
2010
Study completion
2019
First posted
Mar 18, 2016
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.