Diarrhea

A placebo-controlled, randomized; double-blind 2 arm trial

Fibersol-2

Kumudini Medical College and hospital, Mirzapur, Tangail

Tolerability and Acceptability of Fibersol-2 in Children

Tolerability and Acceptability of Fibersol-2 (Resistant Maltodextrin) in Healthy and Diarrheal Children Followed by a Randomized Clinical Trial to Evaluate the Efficacy of Fibersol-2 in Diarrheal Children 1-3 Years Old

Main outcome measure is duration of diarrhea

Stool consistency measured by regular observation

International Centre for Diarrhoeal Disease Research, Bangladesh

A placebo-controlled, randomized; double-blind 2 arm trial to assess the efficacy of fibersol-2 in children with acute watery diarrhea.

Group I will receive 2 doses of the MenACWY-CRM conjugate vaccine (Novartis Vaccines) given 1 month apart. All vaccine doses are 0.5ml and will be administered intramuscularly into the deltoid.

Group II will receive one full dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later.
0.5 mL of MenACWY-PS vaccine will be administered subcutaneously and 0.5 mL of the MenACWY-CRM vaccine will be administered intramuscularly into the deltoid.

Group III will receive a full dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine subcutaneously, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later.

Group IV will receive one fifth dose of MenACWY-PS polysaccharide vaccine meningococcal vaccine, followed by one dose of MenACWY-CRM conjugate vaccine given 1 month later.
0.1 mL of MenACWY-PS vaccine will be administered IM and 0.5 mL of the MenACWY-CRM vaccine will be administered intramuscularly into the deltoid.

Meningitis

Meningococcal Disease

Septicaemia

The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

MenACWY-CRM conjugate vaccine (Menveo, Novartis)

The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection. This vaccine should be administered subcutaneously.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)

To obtain the one-fifth dose of MenACWY-PS, 0.5ml of a full dose of MenACWY-PS will be reconstituted, and then 0.4ml will be discarded prior to subcutaneous injection. The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.

1/5th dose MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)

The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered subcutaneously

Polysaccharide (subcutaneously)-conjugate

Oxford Vaccine Group

Understanding the Immune Response to Two Different Meningitis Vaccines

A Single Centre, Open-label, Randomised Clinical Study to Investigate Meningococcal Serogroup A and C Saccharide Specific B Cell Responses in Adult Volunteers to One of Three Regimens of Meningococcal ACWY Conjugate Vaccine or Meningococcal ACWY Polysaccharide Vaccine Priming Doses Followed by a Booster Dose of the Meningococcal ACWY Conjugate Vaccine

The phenotype of meningococcal serogroup A specific B cells will be observed at day 7 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose quadrivalent meningococcal polysaccharide vaccine and quadrivalent meningococcal conjugate vaccine by Fluorescent Activated Cell Sorting (FACS) analysis. This will be performed at the laboratories of the Oxford Vaccine Group, University of Oxford.

The phenotype of meningococcal serogroup C specific B cells will be observed at day 28 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose quadrivalent meningococcal polysaccharide vaccine and quadrivalent meningococcal conjugate vaccine using flow cytometry.

The measurement of meningococcal serogroup A and C specific memory B cells at day 28 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose Quadrivalent meningococcal polysaccharide vaccine or quadrivalent meningococcal conjugate vaccine, and after the booster immunisation with the conjugate vaccine.

The phenotype of meningococcal serogroup A specific B cells will be observed at day 28 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose quadrivalent meningococcal polysaccharide vaccine and quadrivalent meningococcal conjugate vaccine by Fluorescent Activated Cell Sorting (FACS) analysis. This will be performed at the laboratories of the Oxford Vaccine Group, University of Oxford.

The phenotype of meningococcal serogroup C specific B cells will be observed at day 7 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose quadrivalent meningococcal polysaccharide vaccine and quadrivalent meningococcal conjugate vaccine using flow cytometry.

The measurement of meningococcal serogroup A and C specific plasma cells at day 7 following the initial immunisation with full dose quadrivalent meningococcal polysaccharide vaccine, 1/5th dose Quadrivalent meningococcal polysaccharide vaccine or quadrivalent meningococcal conjugate vaccine, and after the booster immunisation with the conjugate vaccine.

meningitis/carbohydrate

Tolerability and Acceptability of Fibersol-2 in Children

Understanding the Immune Response to Two Different Meningitis Vaccines

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