Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV

Summary

With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) are required to use in the "Strategy of Polio Eradication \& Endgame Strategic Plan 2013-2018" worldwide.

To evaluate the safety and immunogenicity by different sequential schedules of bOPV/tOPV with IPV(sIPV/cIPV), a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month-old in Guangxi Province, China.

Conditions

• Poliomyelitis

Interventions

BIOLOGICAL

1-dose cIPV + 2-doses bOPV (Candy)

Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

1-dose sIPV + 2-doses bOPV (Candy)

Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses cIPV + 1-dose bOPV (Candy)

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses sIPV + 1-dose bOPV (Candy)

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses cIPV + 1-dose tOPV (Candy)

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses sIPV + 1-dose tOPV (Candy)

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

1-dose cIPV + 2-doses bOPV (Liquid)

Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

1-dose sIPV + 2-doses bOPV (Liquid)

Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses cIPV + 1-dose bOPV (Liquid)

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses sIPV + 1-dose bOPV (Liquid)

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses cIPV + 1-dose tOPV (Liquid)

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.

BIOLOGICAL

2-doses sIPV + 1-dose tOPV (Liquid)

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.

Sponsors & Collaborators

• Guangxi Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Institute of Medical Biology, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Zhaojun Mo, Master · Guangxi Province Center for Diseases Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

2 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-15

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• China

Study Locations