Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study

PHASE4CompletedINTERVENTIONAL
Enrollment

1,144

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

IPV at 14 and 22 weeks of age, Rotarix

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

BIOLOGICAL

IPV at 14 and 22 weeks of age, RotaTeq

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

BIOLOGICAL

IPV at 14 and fIPV at 22 weeks, Rotarix

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

BIOLOGICAL

IPV at 14 and fIPV at 22 weeks, RotaTeq

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

BIOLOGICAL

IPV at 6 and fIPV at 22 weeks, Rotarix

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

BIOLOGICAL

IPV at 6 and fIPV at 22 weeks, RotaTeq

Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

BIOLOGICAL

fIPV at 6-14-22 weeks of age, Rotarix

Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.

BIOLOGICAL

fIPV at 6-14-22 weeks of age, RotaTeq

Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.

Trial Locations (1)

Unknown

International Center for Diarrhoeal Disease Research, Bangladesh, Dhaka

All Listed Sponsors
collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

lead

Centers for Disease Control and Prevention

FED

NCT02847026 - Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study | Biotech Hunter | Biotech Hunter