Immunogenicity of Inactivated and Live Polio Vaccines

PHASE3CompletedINTERVENTIONAL
Enrollment

1,206

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

Group A: Trivalent Oral Polio Vaccine

Group A will receive 3 doses of trivalent oral polio vaccine (tOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.

BIOLOGICAL

Group B: Bivalent Oral Polio Vaccine

Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.

BIOLOGICAL

Group C: Inactivated Polio Vaccine

Group C will receive 2 doses of inactivated polio vaccine (IPV) at 6 and 14 weeks of age. IPV will be administered intramuscularly using standard needle and syringe. A challenge dose of tOPV will be administered at 18 weeks of age.

BIOLOGICAL

Group D: fractional IPV (f-IPV)

Group D will receive 2 doses of fractional inactivated polio vaccine (f-IPV) at 6 and 14 weeks of age. f-IPV (one-fifth dose of IPV) will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.

BIOLOGICAL

Arm E: f-IPV and bOPV

Group E will receive 2 doses of f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age. f-IPV will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.

Trial Locations (1)

Unknown

Mirpur Health Clinic, Dhaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

collaborator

Ministry of Health and Family Welfare, Bangladesh

UNKNOWN

collaborator

NanoPass Technologies Ltd

INDUSTRY

lead

Centers for Disease Control and Prevention

FED

NCT01813604 - Immunogenicity of Inactivated and Live Polio Vaccines | Biotech Hunter | Biotech Hunter