Understanding the Immune Response to Two Different Meningitis Vaccines

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

April 30, 2013

Conditions
MeningitisMeningococcal DiseaseSepticaemia
Interventions
BIOLOGICAL

MenACWY-CRM conjugate vaccine (Menveo, Novartis)

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.

BIOLOGICAL

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. 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.

BIOLOGICAL

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. 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.

BIOLOGICAL

1/5th dose 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.

BIOLOGICAL

Polysaccharide (subcutaneously)-conjugate

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

Trial Locations (1)

OX3 7LE

Oxford Vaccine Group, Oxford

All Listed Sponsors
lead

University of Oxford

OTHER

NCT01593514 - Understanding the Immune Response to Two Different Meningitis Vaccines | Biotech Hunter | Biotech Hunter