Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03295318
• Date of registration: 20/09/2017
• Prospective Registration: Yes
• Primary sponsor: Serum Institute of India Pvt. Ltd.
• Public title: Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
• Scientific title: A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age
• Date of first enrolment: November 15, 2017
• Target sample size: 375
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03295318
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Mali

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female children between 12 months and 16 months old inclusive (minimum 365
days of age and maximum 16 months plus 29 days of age);

- For whom parent(s)/legal guardian(s) have given written informed consent after the
nature of the study has been explained according to local regulatory requirements;

- Who the investigator believes that their parent(s)/ guardian(s) will be available for
all the subject visits and would comply with the requirements of the protocol (e.g.,
timely reporting of adverse events, availability for study site visits and home
visits);

- Individuals in good health as determined by the outcome of medical history, physical
examination and clinical judgment of the investigator.

- Individuals who completed their local infant EPI schedule through 9 months of age
(except MenAfriVac dose). A birth dose of OPV is not required)

Exclusion Criteria:

- History of any meningococcal vaccine administration.

- Current or previous, confirmed or suspected disease caused by N. meningitidis.

- Household contact with and/or intimate exposure to an individual with any laboratory
confirmed N. meningitidis infection within 60 days of enrolment.

- History of severe allergic reactions after previous vaccinations or hypersensitivity
to any study vaccine component including tetanus, diphtheria and diphtheria toxoid
(CRM197).

- Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic,
neurological, hepatic, or renal functional abnormality, as determined by medical
history or physical examination.

- Any confirmed or suspected condition with impaired/altered function of immune system
(immunodeficient or autoimmune conditions).

- Have any bleeding disorder which is considered as a contraindication to intramuscular
injection or blood draw.

- Severe acute malnutrition.

- A family history of congenital or hereditary immunodeficiency.

- History of either hepatitis B or hepatitis C virus infection or human immunodeficiency
virus infection.

- Major congenital defects.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within three months prior to the study vaccination or planned
use throughout the study period. (For corticosteroids, this means prednisone, or
equivalent, = 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are
allowed).

- 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.

- Administration of any vaccine within 28 days prior to enrolment in the study or
planned administration of any vaccine within 14 days before or after any study
vaccination.

- Use of any investigational or non-registered drug or vaccine within 30 days prior to
the administration of study vaccines or planned during the study.

- Malaria infection as confirmed by a Rapid Diagnostic Test.

- Individuals who are close family members of individuals conducting this study.

- Have experienced a moderate or severe acute infection and/or fever (defined as
temperature = 37.5°C) within 3 days prior to enrolment.

- Have received systemic antibiotic treatment within 3 days prior to enrolment.

- Non-residence in the study area or intent to move out within six months.

- Any condition which, in the opinion of the investigator, might pose additional risk to
the subject due to participation in the study



Age minimum: 12 Months
Age maximum: 16 Months
Gender: All

Health Condition(s) or Problem(s) studied

Meningitis, Meningococcal

Intervention(s)

Biological: Menactra

Biological: Adjuvanted study formulation NmCV-5

Biological: Non-adjuvanted study formulation NmCV-5

Primary Outcome(s)

Severe solicited adverse event [Time Frame: 7 days post each vaccination]

Secondary Outcome(s)

Serious adverse events [Time Frame: 168 Days]

Seroprotective rSBA titres [Time Frame: 112 days]

Geometric mean of rSBA titres [Time Frame: 112 Days]

Long term protective rSBA titres [Time Frame: 112 days]

Adverse events [Time Frame: 112 Days]

Other adverse events [Time Frame: 168 Days]

Rise in rSBA titres [Time Frame: 112 days]

Solicited reactions [Time Frame: 7 days post each vaccination]

Secondary ID(s)

CVIA-058

ACYWX-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PATH