ISRCTN82484612
Completed
Phase 2
A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants
Serum Institute of India Limited0 sites1,200 target enrollmentAugust 6, 2008
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bacterial meningitis
- Sponsor
- Serum Institute of India Limited
- Enrollment
- 1200
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553685 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553669
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 14 to 18 weeks old
- •2\. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
- •3\. Guardian capable and willing to bring their child or to receive home visits for their child for all follow\-up visits
- •4\. Residence in the study area
- •5\. Fully vaccinated according to the local EPI schedule (Bacillus Calmette\-Guerin \[BCG] and OPV at birth, two doses of diphtheria, tetanus, whole cell pertussis, haemophilus influenzae type B and hepatitis B virus \[DTwPHibHBV] and OPV at 6 and 10 weeks of age)
Exclusion Criteria
- •1\. Previous vaccination against serogroup A Neisseria meningitidis
- •2\. Known exposure to serogroup A N. meningitidis since birth
- •3\. History of allergic disease or known hypersensitivity to any component of the study vaccines
- •4\. History of serious adverse reactions following administration of vaccines included in the local program of immunisation
- •5\. Administration of any vaccine other than EPI vaccines within 30 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 since birth
- •7\. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- •8\. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune\-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
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 ageISRCTN46335400Serum Institute of India Limited (SIIL)340
Completed
Phase 1
A phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new Meningococcal A Conjugate vaccine versus a Meningococcal Polysaccharide A+C reference vaccine and a Tetanus Toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age (India)Meningococcal diseaseInfections and InfestationsISRCTN17662153Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA)72
Completed
Not Applicable
Clinically important venous thromboembolism following lower extremity fractures: epidemiology and preventioIsolated below-knee fractures (tibia and/or fibula) requiring surgical repairInjury, Occupational Diseases, PoisoningFracturesISRCTN23254458niversity of Toronto (Canada)700
Completed
Phase 2
Clinical trial to evaluate the safety and efficacy of CCX140-B in diabetic nephropathyDiabetic nephropathyNutritional, Metabolic, EndocrineISRCTN77691094ChemoCentryx, Inc. (USA)135
Completed
Phase 2
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 ageISRCTN78147026Serum Institute of India Limited (SIIL)600