Bacterial MeningitisPhase 3NCT01547715

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

A Phase 3 study testing Meningococcal ACWY conjugate vaccine in people with Bacterial Meningitis, run by Novartis at 4 sites in India.

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 immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India. Read more about this study

Who is it for?: Ages 2 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Bacterial Meningitis
What is being tested?: Meningococcal ACWY conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 4 sitesIndia
Study dates: Mar 2012to Apr 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 75 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Individuals eligible for enrollment in this study are those:
who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and:
the parent/legal representative has provided written informed consent (greater than or equal to 2 - less than 18 years of age).
have provided written assent (greater than or equal to 7-less than or equal to 18 years)
have provided written informed consent (greater than or equal to 18 to 75 years of age).
who the investigator believes that they or their parents/legal representatives can and will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
who have a negative urine pregnancy test for female subjects of childbearing potential.

Who cannot join

Individuals not eligible to be enrolled in the study are those:
who are unwilling or unable to give written informed assent or consent to participate in the study.
who are perceived to be unreliable or unavailable for the duration of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
who have previously been immunized with a meningococcal vaccine.

Show all 18Show fewer

who have received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
who have experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature greater than or equal to 38°C) within 3 days prior to enrollment.
who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
who have epilepsy or any progressive neurological disease.
who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
receipt of immunosuppressive therapy within 28 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose greater than 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or cancer chemotherapy)
receipt of immunostimulants
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study.
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

4 sites in 1 country.

India4 sites

Osmania Medical College Ethics Commitee, Niloufer Hospital
Hyderabad, Andrapradesh, 500004
Bharati Vidyapeeth University Institutional Ethics Commitee
Katraj, Dhankawadi, 411043
Seth GS Medical College and KEM Hospital
Mumbai, Maharashtra, 400012
Padmasree Dr. D.Y Patil medical College
Pune, Maharashtra, 411018

Other trials in India

About this study

Official title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75 Years of Age in India.

This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.

Conditions: Bacterial Meningitis
Being tested: Meningococcal ACWY conjugate vaccine
Keywords: Meningococcal,, ACWY,, bacterial meningitis,, conjugate vaccine,, healthy, children,, adolescents,, adults,, India
Medical subject headings: Meningitis, Bacterial

What participants receive

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

Meningococcal ACWY conjugate vaccineBiological
All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Study groups in NCT01547715
Study group	Role	What they receive
MenACWY - 2 - 10 Years old	Experimental	Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1. Receives: Biological: Meningococcal ACWY conjugate vaccine
MenACWY - 11 - 18 Years old	Experimental	Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. Receives: Biological: Meningococcal ACWY conjugate vaccine
MenACWY - 19 - 75 Years old	Experimental	Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. Receives: Biological: Meningococcal ACWY conjugate vaccine

What is being measured

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

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as:
- For subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer≥1:8
- For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Measured: Day 29 (1 month post vaccination)
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
Measured: Day 29 (1 month post vaccination)
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
Measured: Day 29 (1 month post vaccination)
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
Measured: Day 29 (1 month post vaccination)

Secondary outcomes (19)

Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.
Measured: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.
Measured: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.
Measured: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.
Measured: Day 29
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.
Measured: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.
Measured: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.
Measured: Day 29 ( ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.
Measured: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.
Measured: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.
Measured: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.
Measured: Day 29 (ie, 1 month post vaccination)
Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.
Measured: From day 1 to Day 7 post vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.
Measured: From day 1 to Day 7 post vaccination
Number of Subjects With Unsolicited Adverse Events
The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.
Measured: Day 1 through day 29

Timeline

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

Mar 2012Apr 2014

First posted8 Mar 2012 (estimated)
Study startMar 2012
Primary completionApr 2014
Study completionApr 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.
Other trials for Bacterial 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01547715
Sponsor's protocol ID: V59_43
Status last verified: Sep 2018
First submitted: 23 Feb 2012
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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All Bacterial Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 75 Years of Age in India.
ClinicalTrials.gov ID: NCT01547715
Acronym / sponsor ID: V59_43
Conditions: Bacterial Meningitis
Keywords: Meningococcal,, ACWY,, bacterial meningitis,, conjugate vaccine,, healthy, children,, adolescents,, adults,, India
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Mar 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 Mar 2012 (estimated)
Results: Posted 31 Dec 2014

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 immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenACWY - 2 - 10 Years old	Experimental	Biological: Meningococcal ACWY conjugate vaccineSubjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1.
MenACWY - 11 - 18 Years old	Experimental	Biological: Meningococcal ACWY conjugate vaccineSubjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.
MenACWY - 19 - 75 Years old	Experimental	Biological: Meningococcal ACWY conjugate vaccineSubjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.

Who may qualify

Ages: 2 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and:
who the investigator believes that they or their parents/legal representatives can and will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
who have a negative urine pregnancy test for female subjects of childbearing potential.

Key exclusion criteria (18 listed)

who are unwilling or unable to give written informed assent or consent to participate in the study.
who are perceived to be unreliable or unavailable for the duration of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
who have previously been immunized with a meningococcal vaccine.

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 ACWY conjugate vaccineAll subjects received a single dose of Meningococcal ACWY conjugate vaccine	Biological	MenACWY - 11 - 18 Years old, MenACWY - 19 - 75 Years old, MenACWY - 2 - 10 Years old

Primary outcome

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
Time frame: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
Time frame: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
Time frame: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
Time frame: Day 29 (1 month post vaccination)
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.

19 secondary outcomes

Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
Time frame: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
Time frame: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
Time frame: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
Time frame: Day 29
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
Time frame: Day 1
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
Time frame: Day 29 (ie, 1 month post vaccination)
hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
Time frame: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
Time frame: Day 29 ( ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
Time frame: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
Time frame: Day 29 (ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
Time frame: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
Time frame: Day 29 (ie, 1 month post vaccination)
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
Time frame: Day 1
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
Time frame: Day 29 (ie, 1 month post vaccination)
Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
Time frame: From day 1 to Day 7 post vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
Time frame: From day 1 to Day 7 post vaccination
Number of Subjects With Unsolicited Adverse Events
Time frame: Day 1 through day 29

Results and safety

Results posted to the registry on 31 Dec 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 - 10 Years	60	60
11 - 18 Years	60	60
19 - 75 Years	60	60

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.

Time frame: Day 29 (1 month post vaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	2 - 10 Years n = 60	11 - 18 Years n = 59	19 - 75 Years n = 58	Overall (≥2 Years) n = 177
Value	75 (62 to 85)	76 (63 to 86)	66 (52 to 78)	72 (65 to 79)

Population analysed: Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C

Time frame: Day 29 (1 month post vaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	2 - 10 Years n = 58	11 - 18 Years n = 59	19 - 75 Years n = 58	Overall (≥2 Years) n = 175
Value	84 (73 to 93)	90 (79 to 96)	90 (79 to 96)	88 (82 to 92)

Population analysed: Analysis was done on the FAS.

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.

Time frame: Day 29 (1 month post vaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	2 - 10 Years n = 60	11 - 18 Years n = 59	19 - 75 Years n = 57	Overall (≥2 Years) n = 176
Value	58 (45 to 71)	51 (37 to 64)	54 (41 to 68)	55 (47 to 62)

Population analysed: Analysis was done on the FAS.

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.

Time frame: Day 29 (1 month post vaccination). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	2 - 10 Years n = 58	11 - 18 Years n = 59	19 - 75 Years n = 57	Overall (≥2 Years) n = 174
Value	69 (55 to 80)	69 (56 to 81)	75 (62 to 86)	71 (64 to 78)

Population analysed: Analysis was done on the FAS.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 29 post vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 - 10 Years	0 of 60 (0%)	10 of 60 (16.7%)	Not reported
11 - 18 Years	0 of 60 (0%)	21 of 60 (35%)	Not reported
19 - 75 Years	1 of 60 (1.7%)	10 of 60 (16.7%)	Not reported
Overall (≥2 Years)	1 of 180 (0.6%)	41 of 180 (22.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Dr. Sanjay Lalwani principal investigator

Bharati Hospital and Research Center

Dr. Nitya Gogtay principal investigator

Seth GS Medical College and KEM Hospital

Dr. A Amaresh principal investigator

Niloufer Hospital, Hyderabad

4 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 Meningococcal ACWY conjugate vaccine in people with Bacterial Meningitis, run by Novartis at 4 sites in India.

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 8 inclusion and 18 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. 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 31 Dec 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?

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. (time frame: Day 29 (1 month post vaccination)). 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 NCT01547715.

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 9 Oct 2018.