A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age
- Conditions
- Meningococcal A diseaseInfections and Infestations
- Registration Number
- ISRCTN78147026
- Lead Sponsor
- Serum Institute of India Limited (SIIL)
- Brief Summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21675889 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553689 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553685 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553683 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553669
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
1. Age 12 to 23 months of age (both included)
2. Written informed consent obtained from the mother, father, or 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. Mother, father, or 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 local Expanded Program on Immunisation (EPI) schedule
1. Previous vaccination against serogroup A Neisseria meningitidis
2. Known exposure to serogroup A Neisseria meningitidis during the three previous months
3. History of allergic disease or known hypersensitivity to any component of the three study vaccines
4. History of Serious Adverse Reactions (SAR) following administration of vaccines included in the local program of immunization
5. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination
6. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the vaccine period
8. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone or equivalent, 0.5 mg/kg/day [topical steroids are allowed])
9. A family history of congenital or hereditary immunodeficiency
10. History of meningitis or seizures or any neurological disorder
11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)
12. 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
13. 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
14. 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
15. 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 rank Signaling Block Age (rSBA) assay.
- Secondary Outcome Measures
Name Time Method