A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy children 2 to 10 years of age

Phase 2

Completed

• Conditions: Meningitis; Bacterial meningitis; Infections and Infestations

• Registration Number: ISRCTN46335400
• Lead Sponsor: Serum Institute of India Limited (SIIL)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553684 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-14
• Study Completion: 2007-11-20
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

1. Age 2 to 10 years of age (both included)
2. Written informed consent obtained from parents or legal guardian of the child
3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
4. Parents or legal guardian capable and willing to bring their child or to receive home visits (for their child) for all follow-up visits
5. Residence in the study area
6. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule

Exclusion Criteria

1. Previous vaccination against Neisseria meningitidis
2. Known exposure to Neisseria meningitidis during the three previous months
3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation
4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination
5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period
7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids are allowed)
8. A family history of congenital or hereditary immunodeficiency
9. History of meningitis or seizures or any neurological disorder
10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)
11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
14. Non residence in the study area or intent to move out within one year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e., a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by a rabbit complement Serum Bactericidal Assay (rSBA).