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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Meningitis
• Intervention / Treatment: Biological: Meningococcal ACWY conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).
2. 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).
3. who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
4. 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.
13. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day 29 (1 month post vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Day 1 through day 29

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: 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 record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: India; adults,; adolescents,; Meningococcal,; ACWY,; bacterial meningitis,; conjugate vaccine,; healthy, children,
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Meningitis; Meningitis, Bacterial
• Other Study ID Numbers: V59_43