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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01547715
• Collaborator: Novartis Vaccines (Industry)
• Enrollment: 180
• Locations: 4
• Arms: 3
• Duration (Months): 25
• Patients Per Site: 45
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Meningitis	Biological: Meningococcal ACWY conjugate vaccine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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.
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MenACWY - 2 - 10 Years old Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1.	Biological: Meningococcal ACWY conjugate vaccine; All subjects received a single dose of Meningococcal ACWY conjugate vaccine
Experimental: MenACWY - 11 - 18 Years old Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.	Biological: Meningococcal ACWY conjugate vaccine; All subjects received a single dose of Meningococcal ACWY conjugate vaccine
Experimental: MenACWY - 19 - 75 Years old Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1.	Biological: Meningococcal ACWY conjugate vaccine; All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Outcome Measures

Primary Outcome Measures

1. Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. [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.

2. Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C [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.

3. Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. [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.

4. Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. [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.

Secondary Outcome Measures

1. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. [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.

2. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. [Day 29 (ie, 1 month post vaccination)]

   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.

3. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. [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.

4. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. [Day 29 (ie, 1 month post vaccination)]

   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.

5. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. [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.

6. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. [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.

7. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 [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.

8. Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 [Day 29 (ie, 1 month post vaccination)]

   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.

9. hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 [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.

10. hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 [Day 29 ( ie, 1 month post vaccination)]

    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.

11. hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 [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.

12. hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 [Day 29 (ie, 1 month post vaccination)]

    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.

13. hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 [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.

14. hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 [Day 29 (ie, 1 month post vaccination)]

    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.

15. hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 [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.

16. hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 [Day 29 (ie, 1 month post vaccination)]

    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.

17. Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination [From day 1 to Day 7 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.

18. Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination [From day 1 to Day 7 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.

19. Number of Subjects With Unsolicited Adverse Events [Day 1 through day 29]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Individuals eligible for enrollment in this study are those:

1. 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).

1. 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).

2. who are in good health as determined by medical history, physical exam, clinical judgment of the investigator

3. who have a negative urine pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

1. who are unwilling or unable to give written informed assent or consent to participate in the study.

2. who are perceived to be unreliable or unavailable for the duration of the study period.

3. who had a previous or suspected disease caused by N. meningitidis.

4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.

5. who have previously been immunized with a meningococcal vaccine.

6. 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.

7. 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)

8. 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.

9. 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).

10. who have epilepsy or any progressive neurological disease.

11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.

12. 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.

1. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

2. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osmania Medical College Ethics Commitee, Niloufer Hospital	Hyderabad	Andrapradesh	India	500004
2	Bharati Vidyapeeth University Institutional Ethics Commitee	Katraj	Dhankawadi	India	411043
3	Padmasree Dr. D.Y Patil medical College	Pune	Maharashtra	India	411018
4	Seth GS Medical College and KEM Hospital	Mumbai	Maharastra	India	400012

Sponsors and Collaborators

• Novartis
• Novartis Vaccines

Investigators

• Principal Investigator: Dr. Sanjay Lalwani, Bharati Hospital and Research Center
• Principal Investigator: Dr. Nitya Gogtay, Seth GS Medical College and KEM Hospital
• Principal Investigator: Dr. A Amaresh, Niloufer Hospital, Hyderabad
• Principal Investigator: Dr. Sharad Agarkhedkar, Padmasree Dr. D.Y.patil Medical College, Hospital & Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT01547715
• Other Study ID Numbers: V59_43
• First Posted: Mar 8, 2012
• Last Update Posted: Oct 9, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Novartis: Meningococcal,; ACWY,; bacterial meningitis,; conjugate vaccine,; healthy, children,; adolescents,; adults,; India
• Additional relevant MeSH terms: Meningitis, Bacterial; Meningitis

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled from 3 study sites.
Pre-assignment Detail	All the enrolled subjects were included in the trial.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years
Arm/Group Description	Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.
Period Title: Overall Study
STARTED	60	60	60
COMPLETED	60	60	60
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Total
Arm/Group Description	Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1	Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1	Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1.	Total of all reporting groups
Overall Participants	60	60	60	180
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	5.77 (2.5)	14.03 (1.931)	32.67 (12.297)	17.49 (13.432)
Sex: Female, Male (Count of Participants)
FEMALE	33 55%	33 55%	21 35%	87 48.3%
MALE	27 45%	27 45%	39 65%	93 51.7%

Outcome Measures

1. Primary Outcome

Title	Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
Description	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.
Time Frame	Day 29 (1 month post vaccination)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	58	177
Number (95% Confidence Interval) [Percentages of subjects]	75	76	66	72

2. Primary Outcome

Title	Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
Description	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.
Time Frame	Day 29 (1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	58	59	58	175
Number (95% Confidence Interval) [Percentages of subjects]	84	90	90	88

3. Primary Outcome

Title	Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
Description	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.
Time Frame	Day 29 (1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	57	176
Number (95% Confidence Interval) [Percentages of subjects]	58	51	54	55

4. Primary Outcome

Title	Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
Description	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.
Time Frame	Day 29 (1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	58	59	57	174
Number (95% Confidence Interval) [Percentages of subjects]	69	69	75	71

5. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	60	179
Number (95% Confidence Interval) [Percentage of subjects]	0	2	2	1

6. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Number (95% Confidence Interval) [Percentages of subjects]	75	77	66	72

7. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	58	59	60	177
Number (95% Confidence Interval) [Percentages of subjects]	14	24	25	21

8. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Number (95% Confidence Interval) [Percentages of subjects]	92	97	97	95

9. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	59	178
Number (95% Confidence Interval) [Percentages of subjects]	52	63	59	58

10. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
Description	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.
Time Frame	Day 29

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Number (95% Confidence Interval) [Percentage of subjects]	95	95	93	94

11. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	59	59	59	177
Number (95% Confidence Interval) [Percentages of subjects]	22	53	53	42

12. Secondary Outcome

Title	Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	59	60	58	177
Number (95% Confidence Interval) [Percentages of subjects]	83	95	93	90

13. Secondary Outcome

Title	hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	60	179
Geometric Mean (95% Confidence Interval) [Titer]	2.08	2.05	2.07	2.07

14. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
Description	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.
Time Frame	Day 29 ( ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Geometric Mean (95% Confidence Interval) [Titer]	30	50	29	35

15. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	58	59	60	177
Geometric Mean (95% Confidence Interval) [Titer]	2.88	4.01	4.14	3.63

16. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Geometric Mean (95% Confidence Interval) [Titer]	67	191	287	153

17. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	59	59	178
Geometric Mean (95% Confidence Interval) [Titer]	9.27	14	12	11

18. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	58	178
Geometric Mean (95% Confidence Interval) [Titer]	60	75	116	80

19. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	59	59	59	177
Geometric Mean (95% Confidence Interval) [Titer]	3.59	7.87	8.69	6.26

20. Secondary Outcome

Title	hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
Description	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.
Time Frame	Day 29 (ie, 1 month post vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was done on the FAS.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	59	60	58	177
Geometric Mean (95% Confidence Interval) [Titer]	45	105	173	93

21. Secondary Outcome

Title	Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
Description	The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.
Time Frame	From day 1 to Day 7 post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	60	180
INJECTION SITE REACTIONS	5 8.3%	17 28.3%	5 8.3%	27 15%
SYSTEMIC REACTIONS	3 5%	7 11.7%	9 15%	19 10.6%

22. Secondary Outcome

Title	Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
Description	The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.
Time Frame	From day 1 to Day 7 post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the safety analysis set.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	60	180
ANALGESIC ANTIPYRETIC	2 3.3%	5 8.3%	2 3.3%	9 5%
Body Temperature >=40C	0 0%	0 0%	0 0%	0 0%
ERYTHEMA (mm)	0 0%	0 0%	0 0%	0 0%
INDURATION (mm)	0 0%	0 0%	0 0%	0 0%
PAIN	4 6.7%	17 28.3%	5 8.3%	26 14.4%
TENDERNESS	1 1.7%	0 0%	0 0%	1 0.6%
ARTHRALGIA	1 1.7%	1 1.7%	0 0%	2 1.1%
BODY TEMPERATURE >=38C	1 1.7%	1 1.7%	1 1.7%	3 1.7%
CHANGE IN EATING HABITS	0 0%	0 0%	0 0%	0 0%
CHILLS	0 0%	4 6.7%	2 3.3%	6 3.3%
DIARRHEA	0 0%	0 0%	0 0%	0 0%
HEADACHE	2 3.3%	5 8.3%	7 11.7%	14 7.8%
IRRITABILITY	0 0%	0 0%	0 0%	0 0%
MALAISE	2 3.3%	2 3.3%	2 3.3%	6 3.3%
MYALGIA	1 1.7%	0 0%	2 3.3%	3 1.7%
NAUSEA	0 0%	1 1.7%	1 1.7%	2 1.1%
RASH	0 0%	0 0%	0 0%	0 0%
SLEEPINESS	0 0%	0 0%	0 0%	0 0%
VOMITING	0 0%	0 0%	0 0%	0 0%

23. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events
Description	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.
Time Frame	Day 1 through day 29

Outcome Measure Data

Analysis Population Description

The analysis was performed on the safety analysis dataset.

Arm/Group Title	2 - 10 Years	11 - 18 Years	19 - 75 Years	Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.	Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
Measure Participants	60	60	60	180
Any Unsolicited AE	9 15%	6 10%	4 6.7%	19 10.6%
Any SAE	0 0%	0 0%	1 1.7%	0 0%
Medically Attended AEs	8 13.3%	5 8.3%	4 6.7%	17 9.4%
AEs Leading to premature withdrawal	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Day 1 to Day 29 post vaccination.
Adverse Event Reporting Description	Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
Arm/Group Title	2 - 10 Years		11 - 18 Years		19 - 75 Years		Overall (≥2 Years)
Arm/Group Description	Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1.		Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1.		Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1		Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1.
All Cause Mortality
	2 - 10 Years		11 - 18 Years		19 - 75 Years		Overall (≥2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	2 - 10 Years		11 - 18 Years		19 - 75 Years		Overall (≥2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)		1/60 (1.7%)		1/180 (0.6%)
General disorders
PYREXIA	0/60 (0%)		0/60 (0%)		1/60 (1.7%)		1/180 (0.6%)
Other (Not Including Serious) Adverse Events
	2 - 10 Years		11 - 18 Years		19 - 75 Years		Overall (≥2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/60 (16.7%)		21/60 (35%)		10/60 (16.7%)		41/180 (22.8%)
General disorders
CHILLS	0/60 (0%)		4/60 (6.7%)		2/60 (3.3%)		6/180 (3.3%)
INJECTION SITE PAIN	5/60 (8.3%)		17/60 (28.3%)		5/60 (8.3%)		27/180 (15%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	4/60 (6.7%)		1/60 (1.7%)		0/60 (0%)		5/180 (2.8%)
Nervous system disorders
HEADACHE	2/60 (3.3%)		5/60 (8.3%)		7/60 (11.7%)		14/180 (7.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.