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

NCT01547715 | Completed Phase 3 Results

• 1 other identifier: V59_43
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Bacterial Meningitis

Keywords

Meningococcal,; ACWY,; bacterial meningitis,; conjugate vaccine,; healthy, children,; adolescents,; adults,; India

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Percentages of Subjects With hSBA ≥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.

  Day 29 (ie, 1 month post vaccination)

• Percentages of Subjects With hSBA ≥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.

  Day 29 (ie, 1 month post vaccination)

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

  Day 1

Study Arms (3)

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.

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.

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.

Biological: Meningococcal ACWY conjugate vaccine

Interventions

Meningococcal ACWY conjugate vaccine BIOLOGICAL

All subjects received a single dose of Meningococcal ACWY conjugate vaccine

MenACWY - 11 - 18 Years old; MenACWY - 19 - 75 Years old; MenACWY - 2 - 10 Years old

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (4)

Osmania Medical College Ethics Commitee, Niloufer Hospital

Hyderabad, Andrapradesh, 500004, India

Location

Bharati Vidyapeeth University Institutional Ethics Commitee

Katraj, Dhankawadi, 411043, India

Location

Seth GS Medical College and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Padmasree Dr. D.Y Patil medical College

Pune, Maharashtra, 411018, India

Location

MeSH Terms

Conditions

Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics SRL

RegistryContactVaccinesUS@novartis.com

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 8, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 9, 2018
• Results First Posted: December 31, 2014

Record last verified: 2018-09

Locations

IN (4)