Who is sponsoring NCT04636827?

NCT04636827 is sponsored by China National Biotec Group Company Limited.

What condition does NCT04636827 study?

NCT04636827 studies Vaccination.

What drugs are being tested in NCT04636827?

Interventions: sIPV+DTaP+HepA, sIPV, DTaP, HepA.

What is the status of NCT04636827?

NCT04636827 is currently UNKNOWN.

Last reviewed 2020-11-16 · How we verify

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)

NCT04636827 Phase 4 UNKNOWN

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: 1. Group 1: sIPV + DTaP + HepA, 2. Group 2: sIPV only, 3. Group 3: DTaP only, 4. Group 4: HepA only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

Details

Lead sponsor	China National Biotec Group Company Limited
Phase	Phase 4
Status	UNKNOWN
Enrolment	600
Start date	2020-11-11
Completion	2021-12

Conditions

Vaccination

Interventions

sIPV+DTaP+HepA
sIPV
DTaP
HepA

Primary outcomes

Seroconversion rate (sIPV) — Baseline (before vaccination) results
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Seroconversion rate (sIPV) — Results obtained 30-40 days after vaccination
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Seroconversion rate (DTaP) — Baseline (before vaccination) results
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Seroconversion rate (DTaP) — Results obtained 30-40 days after vaccination
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Seroconversion rate (HepA) — Baseline (before vaccination) results
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Seroconversion rate (HepA) — Results obtained 30-40 days after vaccination
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects

Countries

China