Meningococcal DiseasePhase 3NCT01682876

Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

A Phase 3 study testing MenACWY-CRM in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age. Read more about this study

Who is it for?: Ages 2 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Infections, Meningococcal
What is being tested?: MenACWY-CRM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 715 participants
Where: 19 sitesUnited States
Study dates: 7 Oct 2012to 30 May 2014
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 2 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Who cannot join

Unwilling or unable to give written informed assent or consent to participate in the study.
Perceived to be unreliable or unavailable for the duration of the study period.
Previous confirmed or suspected disease caused by N. meningitidis.
Previously immunized with a meningococcal vaccine (licensed or investigational).
Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.

Show all 15Show fewer

(certain exceptions influenza vaccines apply)
Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
receipt of immunosuppressive therapy,
receipt of immunostimulants,
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Bellevue, Nebraska, 68005
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Council Bluffs, Iowa, 51503
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Fremont, Nebraska, 68025
GSK Investigational Site
Johnson City, New York, 13790
GSK Investigational Site
Lake Mary, Florida, 32746
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Niles, Michigan, 49120
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Sacramento, California, 95822
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

Conditions: Meningococcal Disease, Infections, Meningococcal
Being tested: MenACWY-CRM
Keywords: Prevention of meningococcal disease, children, vaccine
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MenACWY-CRMBiological
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm

Study groups in NCT01682876
Study group	Role	What they receive
2 through 5 years (1 Vac) MenACWY-CRM 1	Placebo comparator	Subjects 2 through 5 years received one vaccination of MenACWY-CRM Receives: Biological: MenACWY-CRM
2 through 5 years (2 Vac) MenACWY-CRM 2	Active comparator	Subjects 2 through 5 years received two vaccinations of MenACWY-CRM Receives: Biological: MenACWY-CRM
6 through 10 years (1 Vac) MenACWY-CRM 3	Placebo comparator	Subjects 6 through 10 years received one vaccination of MenACWY-CRM Receives: Biological: MenACWY-CRM
6 through 10 years (2 Vac) MenACWY-CRM 4	Active comparator	Subjects 6 through 10 years received two vaccinations of MenACWY-CRM Receives: Biological: MenACWY-CRM

What is being measured

The primary outcome is the main question the study is designed to answer.

Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Measured: One Month After Last Vaccination ( day 86)
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Measured: One Month After Last Vaccination (day 86)

Secondary outcomes (8)

Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.
Measured: One Month After Last Vaccination (day 86)
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.
Measured: One Month After Last Vaccination (day 86)
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.
Measured: One year after one vaccination or two vaccinations (day 422).
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.
Measured: One year after one vaccination or two vaccinations (day 422).
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
Measured: From Days 1-7 after each vaccination
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
Measured: From Days 1-7 after each vaccination
Number of Subjects Who Reported Selected AEs After Any Vaccination
Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM
Measured: Day 1 to Day 86
Number of Subjects Who Reported Selected AEs After Any Vaccination
Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM
Measured: Day 1 to Day 422

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201230 May 2014

First posted11 Sep 2012 (estimated)
Study start7 Oct 2012
Primary completion2 Jul 2013
Study completion30 May 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 715 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682876
Sponsor's protocol ID: 205238
Other IDs: V59_57, 2011-004421-27
Status last verified: Jun 2019
First submitted: 7 Sep 2012
Last updated: 14 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Johnston W, Essink B, Kirstein J, Forleo-Neto E, Percell S, Han L, Keshavan P, Smolenov I. Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age. Pediatr Infect Dis J. 2016 Jan;35(1):e19-27. doi: 10.1097/INF.0000000000000931.
PubMed 26398741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
ClinicalTrials.gov ID: NCT01682876
Acronym / sponsor ID: 205238
Conditions: Meningococcal Disease, Infections, Meningococcal
Keywords: Prevention of meningococcal disease, children, vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 715 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Oct 2012 (actual)
Primary completion: 2 Jul 2013 (actual)
Study completion: 30 May 2014 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Posted 6 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
2 through 5 years (1 Vac) MenACWY-CRM 1	Placebo comparator	Biological: MenACWY-CRMSubjects 2 through 5 years received one vaccination of MenACWY-CRM
2 through 5 years (2 Vac) MenACWY-CRM 2	Active comparator	Biological: MenACWY-CRMSubjects 2 through 5 years received two vaccinations of MenACWY-CRM
6 through 10 years (1 Vac) MenACWY-CRM 3	Placebo comparator	Biological: MenACWY-CRMSubjects 6 through 10 years received one vaccination of MenACWY-CRM
6 through 10 years (2 Vac) MenACWY-CRM 4	Active comparator	Biological: MenACWY-CRMSubjects 6 through 10 years received two vaccinations of MenACWY-CRM

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Key exclusion criteria (15 listed)

Unwilling or unable to give written informed assent or consent to participate in the study.
Perceived to be unreliable or unavailable for the duration of the study period.
Previous confirmed or suspected disease caused by N. meningitidis.
Previously immunized with a meningococcal vaccine (licensed or investigational).
Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.

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
MenACWY-CRMThe investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm	Biological	2 through 5 years (1 Vac) MenACWY-CRM 1, 2 through 5 years (2 Vac) MenACWY-CRM 2, 6 through 10 years (1 Vac) MenACWY-CRM 3, 6 through 10 years (2 Vac) MenACWY-CRM 4

Primary outcome

Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Time frame: One Month After Last Vaccination ( day 86)
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Time frame: One Month After Last Vaccination (day 86)
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.

8 secondary outcomes

Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Time frame: One Month After Last Vaccination (day 86)
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Time frame: One Month After Last Vaccination (day 86)
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Time frame: One year after one vaccination or two vaccinations (day 422).
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Time frame: One year after one vaccination or two vaccinations (day 422).
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Time frame: From Days 1-7 after each vaccination
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Time frame: From Days 1-7 after each vaccination
Number of Subjects Who Reported Selected AEs After Any Vaccination
Time frame: Day 1 to Day 86
Number of Subjects Who Reported Selected AEs After Any Vaccination
Time frame: Day 1 to Day 422

Results and safety

Results posted to the registry on 6 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Through 5 Years (2 Vac)	176	155
2 Through 5 Years (1 Vac)	183	163
6 Through 10 Years (2 Vac)	180	169
6 Through 10 Years (1 Vac)	176	157

Primary outcome: Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination

Time frame: One Month After Last Vaccination ( day 86). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	2 Through 5 Years (2 Vac) n = 136	2 Through 5 Years (1 Vac) n = 144	6 Through 10 Years (2 Vac) n = 153	6 Through 10 Years (1 Vac) n = 142
MenA(N=135,143,152,142)	94 (89 to 97)	75 (67 to 82)	89 (83 to 93)	77 (70 to 84)
MenC(N=131,140,149,142)	92 (86 to 96)	65 (56 to 73)	93 (87 to 96)	73 (65 to 80)
MenW(N=128,135,148,138)	75 (67 to 82)	61 (52 to 69)	58 (50 to 66)	54 (45 to 62)
MenY(N=128,133,148,142)	91 (84 to 95)	64 (55 to 72)	89 (83 to 94)	60 (51 to 68)

2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group Differences at Day 86: 19 (97.5% CI 10 to 28.9), MN method
2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group Differences at Day 86: 27 (97.5% CI 16.9 to 37.7), MN method
2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group Differences at Day 86: 14 (97.5% CI 1.4 to 26.7), MN method

Population analysed: Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Primary outcome: Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination

Time frame: One Month After Last Vaccination (day 86). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	2 Through 5 Years (2 Vac) n = 159	2 Through 5 Years (1 Vac) n = 165	6 Through 10 Years (2 Vac) n = 172	6 Through 10 Years (1 Vac) n = 163
MenA(N=158,163,171,163)	95 (90 to 98)	77 (69 to 83)	89 (84 to 94)	79 (71 to 85)
MenC(N=154,157,167,162)	93 (88 to 96)	65 (57 to 72)	93 (89 to 97)	75 (68 to 82)
MenW(N=150,154,167,159)	75 (68 to 82)	61 (53 to 69)	57 (49 to 65)	52 (44 to 60)
MenY(N=150,153,167,163)	90 (84 to 94)	62 (54 to 70)	89 (83 to 93)	60 (52 to 68)

2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group Differences at Day 86: 18 (98.75% CI 9.1 to 28), MN method
2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group Differences at Day 86: 28 (98.75% CI 17.1 to 38.7), MN method
2 Through 5 Years (2 Vac) vs 2 Through 5 Years (1 Vac): Vaccine Group differences at Day 86: 14 (98.75% CI 1 to 27.1), MN method

Population analysed: Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Through 5 Years (2 Vac)	2 of 179 (1.1%)	148 of 179 (82.7%)	Not reported
2 Through 5 Years (1 Vac)	1 of 179 (0.6%)	142 of 179 (79.3%)	Not reported
6 Through 10 Years (2 Vac)	1 of 181 (0.6%)	153 of 181 (84.5%)	Not reported
6 Through 10 Years (1 Vac)	1 of 174 (0.6%)	133 of 174 (76.4%)	Not reported
Total	5 of 713 (0.7%)	576 of 713 (80.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26398741Johnston W, Essink B, Kirstein J, Forleo-Neto E, Percell S, Han L, Keshavan P, Smolenov I. Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age. Pediatr Infect Dis J. 2016 Jan;35(1):e19-27. doi: 10.1097/INF.0000000000000931.

Related trials for Meningococcal Disease

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
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RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
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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

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACWY-CRM in people with Meningococcal Disease and Infections, Meningococcal, run by GlaxoSmithKline at 19 sites in United States.

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 1 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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. Some participants in this study may receive a placebo. 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 6 Oct 2014). 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?

Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination (time frame: One Month After Last Vaccination ( day 86)). 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?

On the ClinicalTrials.gov record for NCT01682876, which also lists 1 linked publication.

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 14 Jun 2019.