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

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ClinicalTrials.gov Identifier: NCT02712177
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
GlaxoSmithKline
Canadian Immunization Research Network
Information provided by (Responsible Party):
Gaston De Serres, CHU de Quebec-Universite Laval

Brief 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].

Condition or disease Intervention/treatment
Meningococcal Infections Biological: 4CMenb Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB Biological: conjugated pneumococcal vaccine Biological: MMRV

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Study Type : Observational
Actual Enrollment : 4535 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Interaction Between Meningococcal Serogroup B Vaccine (Bexsero™) and Routine Infant Vaccines on the Risk of Occurrence and Recurrence of Adverse Events Following Immunization.
Study Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Other Name: Bexsero

Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

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
Other Name: Bexsero

Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

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
Other Name: Bexsero

Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

Biological: MMRV
Other Name: Priorix Tetra

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
Other Name: Bexsero

Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

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
Other Name: Bexsero

Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

Biological: MMRV
Other Name: Priorix Tetra

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
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar

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
Other Name: Infanrix Hexa

Biological: conjugated pneumococcal vaccine
Other Name: Prevenar




Primary Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 14 Months   (Child)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712177


Sponsors and Collaborators
CHU de Quebec-Universite Laval
GlaxoSmithKline
Canadian Immunization Research Network
Investigators
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Principal Investigator: Gaston De Serres, MD, PhD CHU de Quebec
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gaston De Serres, Researcher, MD, PhD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02712177    
Other Study ID Numbers: 1224
1224 ( Other Identifier: Clinical Study Data request )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gaston De Serres, CHU de Quebec-Universite Laval:
vaccine safety
interaction
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningococcal Infections
Meningitis
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Diseases
Nervous System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs