Meningococcal InfectionsNCT02712177
Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization
An observational study of Meningococcal Infections, run by CHU de Quebec-Universite Laval.
Trial 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]. Read more about this study
- Who is it for?
- Ages 2 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections
- What is being tested?
- 4CMenb, diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB and conjugated pneumococcal vaccine
- Type of treatment
- Vaccines
- How many people
- 4,535 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
None listed.
About this study
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.
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
- Being tested
- 4CMenb, diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, conjugated pneumococcal vaccine, MMRV
- Keywords
- vaccine safety, interaction
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4CMenbBiological
Also called Bexsero
diphtheria,tetanus,pertussis+polio+Hepatitis B+HiBBiological
Also called Infanrix Hexa
conjugated pneumococcal vaccineBiological
Also called Prevenar
MMRVBiological
Also called Priorix Tetra
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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).. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB; Biological: conjugated pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Temperature ≥ 38°C
Measured: 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
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...).
Measured: 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
Fever or systemic reactions other than fever
all systemic signs/symptoms including fever (Temperature ≥ 38°C)
Measured: 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
Injection site reactions
Measured: AT RISK INTERVAL all injection site reactions regardless of their delay of onset. Baseline (CONTROL) risk null.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Canadian Immunization Research Network
- Responsible party
- Principal investigator, Gaston De Serres, CHU de Quebec-Universite Laval
- Investigators
- Gaston De Serres, MD, PhD, Principal investigator, CHU de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712177
- Sponsor's protocol ID
- 1224
- Other IDs
- 1224
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2016
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 22318278Vesikari 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 23324563Baker 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 25769306Zafack 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02712177
- Acronym / sponsor ID
- 1224
- Conditions
- Meningococcal Infections
- Keywords
- vaccine safety, interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,535 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Canadian Immunization Research Network
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Coadministration B_RV246 | – | Biological: 4CMenb, Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccineSubjects in this group received 4CMenB vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations (Infanrix Hexa+Prevenar). |
| Coadministration B_RV234 | – | Biological: 4CMenb, Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccineSubjects in this group received 4CMenB vaccine at 2, 3 and 4 months of age, administered concomitantly with routine infant vaccinations (Infanrix Hexa+Prevenar).. |
| Coadministration B_MMRV12 | – | Biological: 4CMenb, Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccine, Biological: MMRVSubjects 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. |
| Separate administration B246_RV357 | – | Biological: 4CMenb, Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccineSubjects 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. |
| Separate administration B12_MMRV13 | – | Biological: 4CMenb, Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccine, Biological: MMRVSubjects 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. |
| Routine vaccines only at 2, 3 and 4 months of age (RV234) | – | Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccineSubjects in this group received routine infant vaccines (Infanrix Hexa+Prevenar) at 2, 3 and 4 months of age. |
| Routine vaccines only at 2, 4 and 6 months of age.(RV246) | – | Biological: diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB, Biological: conjugated pneumococcal vaccineSubjects in this group received routine infant vaccines (Infanrix Hexa+Prevenar) at 2, 4 and 6 months of age. |
Who may qualify
- Ages
- 2 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (10 listed)
- 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.
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4CMenbAlso: Bexsero | Biological | Coadministration B_MMRV12, Coadministration B_RV234, Coadministration B_RV246, Separate administration B12_MMRV13, Separate administration B246_RV357 |
| diphtheria,tetanus,pertussis+polio+Hepatitis B+HiBAlso: Infanrix Hexa | Biological | Coadministration B_MMRV12, Coadministration B_RV234, Coadministration B_RV246, Routine vaccines only at 2, 3 and 4 months of age (RV234), Routine vaccines only at 2, 4 and 6 months of age.(RV246), Separate administration B12_MMRV13, Separate administration B246_RV357 |
| conjugated pneumococcal vaccineAlso: Prevenar | Biological | Coadministration B_MMRV12, Coadministration B_RV234, Coadministration B_RV246, Routine vaccines only at 2, 3 and 4 months of age (RV234), Routine vaccines only at 2, 4 and 6 months of age.(RV246), Separate administration B12_MMRV13, Separate administration B246_RV357 |
| MMRVAlso: Priorix Tetra | Biological | Coadministration B_MMRV12, Separate administration B12_MMRV13 |
Primary outcome
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
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...).
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)
Injection site reactions
Time frame: AT RISK INTERVAL all injection site reactions regardless of their delay of onset. Baseline (CONTROL) risk null.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 22318278Gossger 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.
- Background: PubMed 23324563Vesikari 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.
- Background: PubMed 25769306Baker 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.
- Derived from this study: PubMed 31110098Zafack 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.
- Individual participant dataSharing planned: No
Related trials for Meningococcal Infections
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaston De Serres, MD, PhD principal investigator
CHU de Quebec
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Infections, run by CHU de Quebec-Universite Laval.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712177, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.