Clinical trial NCT01547715: Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Meningitis
Keywords: Meningococcal,
ACWY,
bacterial meningitis,
conjugate vaccine,
healthy, children,
adolescents,
adults,
India
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2012-03-08
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
timeFrame: Day 29 (1 month post vaccination)
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
timeFrame: Day 29 (1 month post vaccination)
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
timeFrame: Day 29 (1 month post vaccination)
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
timeFrame: Day 29 (1 month post vaccination)
Secondary outcomes:
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
timeFrame: Day 1
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
timeFrame: Day 1
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
timeFrame: Day 1
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
timeFrame: Day 29
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
timeFrame: Day 1
measure: Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
timeFrame: Day 1
measure: hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
timeFrame: Day 29 ( ie, 1 month post vaccination)
measure: hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
timeFrame: Day 1
measure: hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
timeFrame: Day 1
measure: hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
timeFrame: Day 1
measure: hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
timeFrame: Day 29 (ie, 1 month post vaccination)
measure: Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
timeFrame: From day 1 to Day 7 post vaccination
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
timeFrame: From day 1 to Day 7 post vaccination
measure: Number of Subjects With Unsolicited Adverse Events
timeFrame: Day 1 through day 29
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Osmania Medical College Ethics Commitee, Niloufer Hospital
state: Andrapradesh
city: Katraj
country: India
facility: Bharati Vidyapeeth University Institutional Ethics Commitee
state: Dhankawadi
city: Pune
country: India
facility: Padmasree Dr. D.Y Patil medical College
state: Maharashtra
city: Mumbai
country: India
facility: Seth GS Medical College and KEM Hospital
state: Maharastra
Study officials:
affiliation: Bharati Hospital and Research Center
name: Dr. Sanjay Lalwani
role: PRINCIPAL_INVESTIGATOR
affiliation: Seth GS Medical College and KEM Hospital
name: Dr. Nitya Gogtay
role: PRINCIPAL_INVESTIGATOR
affiliation: Niloufer Hospital, Hyderabad
name: Dr. A Amaresh
role: PRINCIPAL_INVESTIGATOR
affiliation: Padmasree Dr. D.Y.patil Medical College, Hospital & Research Center
name: Dr. Sharad Agarkhedkar
role: PRINCIPAL_INVESTIGATOR
References: