Meningococcal MeningitisPhase 3NCT00518180

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

A Phase 3 study testing Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine in people with Meningococcal Meningitis and Human Papillomavirus Infection, run by Novartis Vaccines at 1 site in Costa Rica.

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 will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents Read more about this study

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis
What is being tested?: Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,620 participants
Where: 1 siteCosta Rica
Study dates: Jul 2007to Oct 2008
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 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy adolescents 11-18 years of age
virgins (both male and female) with no intention of becoming sexually active during the study period
who have been properly vaccinated against diphtheria, tetanus, pertussis

Who cannot join

who had a previous confirmed or suspected disease caused by N. meningitidis;
who have previously been immunized with a meningococcal vaccine
who have received prior human papillomavirus (HPV) vaccine;
who have any serious acute, chronic or progressive disease
who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
who have a known or suspected impairment/alteration of immune function, either congenital or acquired
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
who have Down's syndrome or other known cytogenic disorders;

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

San Jose, Costa Rica
San José

Other trials in Costa Rica

About this study

Official title: A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents

Conditions: Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
Being tested: Novartis Meningococcal ACWY Conjugate Vaccine, Tdap Vaccine
Keywords: Meningococcal, meningitis, vaccine, adolescents
Medical subject headings: Meningitis, Meningococcal, Papillomavirus Infections, Whooping Cough, Tetanus, Meningitis

What participants receive

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

Novartis Meningococcal ACWY Conjugate VaccineBiological
One dose of vaccine administered intramuscularly
Tdap VaccineBiological
One dose of vaccine administered intramuscularly
Novartis Meningococcal ACWY Conjugate VaccineBiological
One dose of vaccine administered intramuscularly

Study groups in NCT00518180
Study group	Role	What they receive
MenACWY + Tdap + HPV	Experimental	Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6 Receives: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
MenACWY →Tdap → HPV	Experimental	Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8 Receives: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Tdap →MenACWY → HPV	Experimental	Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8 Receives: Biological: Tdap Vaccine

What is being measured

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

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month post MenACWY vaccination
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Measured: 1 month post Tdap vaccination
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Measured: 1 month post Tdap vaccination

Secondary outcomes (10)

Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
Measured: 1 month post MenACWY vaccination
Percentage of Subjects With Anti-HPV Seroconversion
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
Measured: 1 month post third HPV vaccination
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
Measured: 1 month post third HPV vaccination
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
Measured: 1 month post MenACWY vaccination
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Measured: 1 month post Tdap vaccination
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
Measured: 1 month post Tdap vaccination
Geometric Mean Titers (GMT) of Pertussis Antigens
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Measured: 1 month post Tdap vaccination
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
Measured: 1 month post Tdap vaccination
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
Measured: Days 1 to 7
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Measured: Days 1 to 7

Timeline

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

Jul 2007Oct 2008

First posted20 Aug 2007 (estimated)
Study startJul 2007
Primary completionApr 2008
Study completionOct 2008

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 MeningitisStudies 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: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,620 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518180
Sponsor's protocol ID: V59P18
Status last verified: Apr 2016
First submitted: 17 Aug 2007
Last updated: 18 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.
PubMed 20189491

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

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All Meningococcal Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
ClinicalTrials.gov ID: NCT00518180
Acronym / sponsor ID: V59P18
Conditions: Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
Keywords: Meningococcal, meningitis, vaccine, adolescents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,620 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Apr 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 20 Aug 2007 (estimated)
Results: Posted 4 Oct 2010

Clinical summary

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

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenACWY + Tdap + HPV	Experimental	Biological: Novartis Meningococcal ACWY Conjugate VaccineSubjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
MenACWY →Tdap → HPV	Experimental	Biological: Novartis Meningococcal ACWY Conjugate VaccineSubjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8
Tdap →MenACWY → HPV	Experimental	Biological: Tdap VaccineSubjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Healthy adolescents 11-18 years of age
virgins (both male and female) with no intention of becoming sexually active during the study period
who have been properly vaccinated against diphtheria, tetanus, pertussis

Key exclusion criteria (8 listed)

who had a previous confirmed or suspected disease caused by N. meningitidis;
who have previously been immunized with a meningococcal vaccine
who have received prior human papillomavirus (HPV) vaccine;
who have any serious acute, chronic or progressive disease
who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;

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
Novartis Meningococcal ACWY Conjugate VaccineOne dose of vaccine administered intramuscularly	Biological	MenACWY + Tdap + HPV
Tdap VaccineOne dose of vaccine administered intramuscularly	Biological	Tdap →MenACWY → HPV
Novartis Meningococcal ACWY Conjugate VaccineOne dose of vaccine administered intramuscularly	Biological	MenACWY →Tdap → HPV

Primary outcome

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Time frame: 1 month post MenACWY vaccination
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Time frame: 1 month post Tdap vaccination
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
Time frame: 1 month post Tdap vaccination
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone

10 secondary outcomes

Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Time frame: 1 month post MenACWY vaccination
Percentage of Subjects With Anti-HPV Seroconversion
Time frame: 1 month post third HPV vaccination
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
Time frame: 1 month post third HPV vaccination
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
Time frame: 1 month post MenACWY vaccination
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
Time frame: 1 month post Tdap vaccination
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
Time frame: 1 month post Tdap vaccination
Geometric Mean Titers (GMT) of Pertussis Antigens
Time frame: 1 month post Tdap vaccination
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Time frame: 1 month post Tdap vaccination
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Time frame: Days 1 to 7
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Time frame: Days 1 to 7

Results and safety

Results posted to the registry on 4 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MenACWY+Tdap+HPV	540	475
MenACWY→Tdap→HPV	541	472
Tdap →MenACWY → HPV	539	457

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse

Time frame: 1 month post MenACWY vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	MenACWY+Tdap+HPV n = 494	MenACWY→Tdap→HPV n = 487	Tdap →MenACWY → HPV n = 458
Serogroup A (N=494, 486, 458)	80 (76 to 84)	82 (78 to 85)	87 (83 to 90)
Serogroup C (N=476, 472, 457)	83 (79 to 86)	84 (81 to 88)	84 (80 to 87)
Serogroup W (N=487, 474, 458)	77 (73 to 80)	81 (77 to 84)	65 (61 to 70)
Serogroup Y (N=493, 487, 460)	83 (79 to 86)	82 (79 to 86)	78 (74 to 82)

MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV: Vaccine Group differences (%): -2 (95% CI -6 to 3)
MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV: Vaccine Group differences (%): -1 (95% CI -6 to 3)
MenACWY+Tdap+HPV vs MenACWY→Tdap→HPV: Vaccine Group differences (%): -4 (95% CI -9 to 1)

Population analysed: The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.

Primary outcome: Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL

Time frame: 1 month post Tdap vaccination. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	MenACWY+Tdap+HPV n = 492	MenACWY→Tdap→HPV n = 458	Tdap →MenACWY → HPV n = 487
Diphtheria	100 (99 to 100)	100 (99 to 100)	98 (96 to 99)
Tetanus	100 (99 to 100)	100 (99 to 100)	100 (99 to 100)

MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV: Vaccine Group differences (%): 2 (95% CI 1 to 4)
MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV: Vaccine Group differences (%): 0 (95% CI -1 to 1)

Population analysed: The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.

Primary outcome: Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)

Time frame: 1 month post Tdap vaccination. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	MenACWY+Tdap+HPV n = 492	MenACWY→Tdap→HPV n = 458	Tdap →MenACWY → HPV n = 487
Anti-PT (N=479, 451, 477)	51 (47 to 55)	79 (72 to 87)	63 (58 to 69)
Anti-FHA (N=489, 457, 485)	342 (310 to 376)	1106 (989 to 1238)	511 (464 to 563)
Anti-PRN (N=492, 458, 487)	819 (727 to 923)	1563 (1390 to 1758)	1197 (1061 to 1350)

MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV: Vaccine Group Ratio: 0.8 (95% CI 0.72 to 0.9)
MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV: Vaccine Group Ratio: 0.68 (95% CI 0.58 to 0.81)
MenACWY+Tdap+HPV vs Tdap →MenACWY → HPV: Vaccine Group Ratio: 0.67 (95% CI 0.58 to 0.76)

Population analysed: The analysis was performed on the per-protocol (PP) population.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 30-day period following each vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY+Tdap+HPV	1 of 540 (0.2%)	495 of 540 (91.7%)	Not reported
MenACWY→Tdap→HPV	7 of 541 (1.3%)	489 of 541 (90.4%)	Not reported
Tdap → MenACWY → HPV	3 of 539 (0.6%)	482 of 539 (89.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20189491Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.

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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.

Novartis Vaccines and Diagnostics study director

Novartis

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

Questions about this trial

What is this clinical trial studying?

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 8 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Costa Rica. 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 4 Oct 2010). 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?

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse (time frame: 1 month post MenACWY vaccination). The study lists 3 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 NCT00518180, 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 18 May 2016.