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

Bacterial Meningitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547715
• Other study ID #: V59_43
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: September 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Meningitis
• Meningitis
• Meningitis, Bacterial

Intervention

Biological:
• Meningococcal ACWY conjugate vaccine
All subjects received a single dose of Meningococcal ACWY conjugate vaccine

Locations

Country	Name	City	State
India	Osmania Medical College Ethics Commitee, Niloufer Hospital	Hyderabad	Andrapradesh
India	Bharati Vidyapeeth University Institutional Ethics Commitee	Katraj	Dhankawadi
India	Seth GS Medical College and KEM Hospital	Mumbai	Maharastra
India	Padmasree Dr. D.Y Patil medical College	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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