A study to check immunogenicity and safety of Meningococcal ACYWX Conjugate Vaccine in Healthy Indian Children of 9 months to 17 Years of Age

A Phase 3, Randomized, Double-blind, Controlled, Multi-Center Study to Compare Immunogenicity and Safety of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) with that of Licensed Meningococcal ACWY Vaccine MenactraÂ® in Healthy Indian Children of 9 months to 17 Years of Age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076975

Enrollment

810

Registered

2024-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NmCV-5: The meningococcal vaccine NmCV-5 manufactured by Serum Institute of India Pvt. Ltd. is a pentavalent conjugate vaccine composed of serogroups A, C, Y, W, and X of Neisseria meni

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parent written informed consent. 2.Participants assent (verbal assent for 7 to 11 years old children and written assent for 12 to 17 years old children) 3.Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test 4.Healthy, as determined by medical history and clinical assessment of the investigator.

Exclusion criteria

Exclusion criteria: 1.Acute illness 2.H/O meningococcal vaccine administration. 3.History of severe allergic reactions after previous vaccinations or hypersensitivity to tetanus, diphtheria and diphtheria toxoid (CRM197). 4.Any confirmed or suspected condition with impaired/altered function of immune system 5.Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination 6.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period. 7.Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines 8.Acute or chronic, clinically significant systemic disorder/disease. 9.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study

Design outcomes

Primary

Measure	Time frame
Percentage of participants with seroresponse against each meningococcal serogroup A, C, W, Y and X.Timepoint: Cohort 1: Children 9 to 23 months: at Day 29 in NmCV-5 group and at Day 112 in Menactra group. Cohort 2, Children 2 to 17 years of age: at Day 29	—

Secondary

Measure	Time frame
rSBA Geometric mean titers (GMT)Timepoint: Cohort 1: at Days 1, 29 and 112 Cohort 2: at at Days 1 and 29;rSBA titers â?¥ 1:8Timepoint: Cohort 1: at Days 1, 29 and 112 Cohort 2: at at Days 1 and 29;rSBA titers â?¥ 1:128Timepoint: Cohort 1: at Days 1, 29 and 112 Cohort 2: at at Days 1 and 29	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni MD

Serum Institute of India Private Limited (SIIPL)

drpsk@seruminstitute.com912071946836

Outcome results