Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine (TTbOPV)

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Treatments

Biological: poliovirus vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02785705

Tiantan-201417903

Details and patient eligibility

About

Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.

Full description

A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.

Enrollment

600 patients

Sex

All

Ages

60 to 90 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.

Exclusion criteria

Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

600 participants in 6 patient groups

cIPV-bOPV-bOPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially.

Treatment:

Biological: poliovirus vaccine

cIPV-tOPV-tOPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.

Treatment:

Biological: poliovirus vaccine

cIPV-cIPV-bOPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially.

Treatment:

Biological: poliovirus vaccine

cIPV-cIPV-tOPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.

Treatment:

Biological: poliovirus vaccine

cIPV-cIPV-cIPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine.

Treatment:

Biological: poliovirus vaccine

tOPV-tOPV-tOPV poliovirus vaccine

Experimental group

Description:

Participants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine .