Infections, MeningococcalPhase 3NCT02106390
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
A Phase 3 study testing Meningococcal group B Vaccine, rMenB+OMV NZ and Meningococcal ACWY Conjugate Vaccine, MenACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone. Read more about this study
- Who is it for?
- Ages 85 to 119 daysHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal group B Vaccine, rMenB+OMV NZ and Meningococcal ACWY Conjugate Vaccine, MenACWY
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Jun 2014to 14 Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 to 119 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
- Available for all the visits scheduled in the study.
- In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
- Previous known or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
- History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
- Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
Show all 15Show fewer
- Immune deficiency disorder, or known HIV infection.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
- History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
- History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
- Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
- Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
- Family members or household members of site research staff.
- Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
- History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Mexico4 sites
GSK Investigational Site
Mexico City, 04530
GSK Investigational Site
Mexico City, 06400
GSK Investigational Site
Mexico City, 06760
GSK Investigational Site
Morelia, 58070
Argentina3 sites
GSK Investigational Site
Buenos Aires, C1425DEM
GSK Investigational Site
Buenos Aires, C1425EFD
GSK Investigational Site
Córdoba, X5000JRD
About this study
Official title: A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal group B Vaccine, rMenB+OMV NZ, Meningococcal ACWY Conjugate Vaccine, MenACWY
- Keywords
- Central Nervous System Diseases, Nervous System Diseases, Meningitis
- Medical subject headings
- Meningococcal Infections, Central Nervous System Diseases, Nervous System Diseases, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal group B Vaccine, rMenB+OMV NZBiological
Also called Bexsero®
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Meningococcal ACWY Conjugate Vaccine, MenACWYBiological
Also called Menveo®
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
| Study group | Role | What they receive |
|---|---|---|
| rMenB+ACWY | Experimental | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. Receives: Biological: Meningococcal group B Vaccine, rMenB+OMV NZ; Biological: Meningococcal ACWY Conjugate Vaccine, MenACWY |
| rMENB | Active comparator | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. Receives: Biological: Meningococcal group B Vaccine, rMenB+OMV NZ |
| MenACWY | Active comparator | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. Receives: Biological: Meningococcal ACWY Conjugate Vaccine, MenACWY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs.
This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
Secondary outcomes (31)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at baseline (Day 1).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Measured: At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Measured: At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
Measured: At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
Measured: At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the first vaccination (Day 1).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Measured: At Day 1
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 one month after the third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 331 (One month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 1
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 1
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 \& M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).
Measured: At Day 331 (one month after fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 \& Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).
Measured: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301).
This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups.
For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2).
Measured: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W \& Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4).
Measured: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 1
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y at one month after the third vaccination (Day 151).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 151 (one month before the third vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 \& Y at one month after the fourth vaccination (Day 331).
This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Measured: At Day 331 (one month after the fourth vaccination)
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination
Measured: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With Unsolicited Adverse Events
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Measured: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.
Measured: Throughout the whole study period (from Day 1 upto Day 331)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start5 Jun 2014
- Primary completion14 Oct 2016
- Study completion14 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106390
- Sponsor's protocol ID
- 205240
- Other IDs
- V72_56, 2016-005117-44, 2016
- Status last verified
- Jan 2018
- First submitted
- 14 Feb 2014
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
- ClinicalTrials.gov ID
- NCT02106390
- Acronym / sponsor ID
- 205240
- Conditions
- Infections, Meningococcal
- Keywords
- Central Nervous System Diseases, Nervous System Diseases, Meningitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 22 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rMenB+ACWY | Experimental | Biological: Meningococcal group B Vaccine, rMenB+OMV NZ, Biological: Meningococcal ACWY Conjugate Vaccine, MenACWYApproximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| rMENB | Active comparator | Biological: Meningococcal group B Vaccine, rMenB+OMV NZApproximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| MenACWY | Active comparator | Biological: Meningococcal ACWY Conjugate Vaccine, MenACWYApproximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
Who may qualify
- Ages
- 85 to 119 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
- Available for all the visits scheduled in the study.
- In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (15 listed)
- History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
- Previous known or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
- History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
- Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
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 |
|---|---|---|
| Meningococcal group B Vaccine, rMenB+OMV NZAlso: Bexsero®4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. | Biological | rMENB, rMenB+ACWY |
| Meningococcal ACWY Conjugate Vaccine, MenACWYAlso: Menveo®4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. | Biological | MenACWY, rMenB+ACWY |
Primary outcome
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
Time frame: At Day 331 (one month after the fourth vaccination)
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 331 (one month after the fourth vaccination)
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
31 secondary outcomes
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Time frame: At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Time frame: At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Time frame: At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Time frame: At Day 331 (one month after the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Time frame: At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Time frame: At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Time frame: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 1
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Time frame: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Time frame: At Day 331 (One month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 1
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
Time frame: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 1
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 331 (one month after the fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
Time frame: At Day 331 (one month after fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
Time frame: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
Time frame: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 1
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 151 (one month before the third vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Time frame: At Day 331 (one month after the fourth vaccination)
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With Unsolicited Adverse Events
Time frame: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
Time frame: Throughout the whole study period (from Day 1 upto Day 331)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infections, Meningococcal
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.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal group B Vaccine, rMenB+OMV NZ and Meningococcal ACWY Conjugate Vaccine, MenACWY in people with Infections, Meningococcal, run by GlaxoSmithKline at 7 sites in 2 countries.
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 3 inclusion and 15 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Mexico, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains (time frame: At Day 331 (one month after the fourth vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.