A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years

• ClinicalTrials.gov Identifier: NCT05144464
• Recruitment Status: Enrolling by invitation
• First Posted: December 3, 2021
• Last Update Posted: March 31, 2022
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborator: Jiangsu Jindike Biotechnology Co., Ltd.
• Information provided by (Responsible Party): Jiangsu Province Centers for Disease Control and Prevention

Study Description

Brief Summary:

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Quadrivalent influenza vaccine	Phase 4

Detailed Description:

Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.

Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects received 2 doses of an inactivated quadrivalent influenza vaccine, 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
• Actual Study Start Date: September 19, 2021
• Actual Primary Completion Date: November 23, 2021
• Estimated Study Completion Date: April 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Quadrivalent influenza vaccine; Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.	Biological: Quadrivalent influenza vaccine; Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40% [ Time Frame: day 28 after dose 2 ]
   The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
2. Number of participants with Adverse Reactions (ARs) [ Time Frame: 28 days after each vaccination ]
   Frequency and severity of ARs for 28 days after each vaccination

Secondary Outcome Measures :

1. the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70% [ Time Frame: day 28 after dose 2 ]
   A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
2. Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5 [ Time Frame: day 28 after dose 2 ]
   Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain
3. Number of participants with Adverse Events (AEs) [ Time Frame: 28 days after each vaccination ]
   Frequency and severity of AEs for 28 days after each vaccination
4. Number of participants with Serious Adverse Events (SAE) [ Time Frame: 6 months after the last vaccination ]
   Frequency of SAEs for 6 months after the last vaccination

Other Outcome Measures:

1. Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2 [ Time Frame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. ]
   The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
2. Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2 [ Time Frame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. ]
3. Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2 [ Time Frame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. ]
   A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
4. Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1 and dose 2 [ Time Frame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2. ]
   Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Aged 3-8 years old
• Healthy subjects judged from medical history and clinical examination
• Subjects themselves or their guardians able to understand and sign the informed consent
• Subjects themselves or their guardians can and will comply with the requirements of the protocol
• Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
• Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

• Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
• Subject who is allergic to any ingredient of the vaccine
• Subject with damaged or low immune function which has already been known
• Subject with acute febrile illness or infectious disease
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
• Subject who has serious allergic history
• Subject who developed guillain-Barre syndrome post influenza vaccination
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of influenza vaccine in last 6 month
• Any prior administration of blood products in last 3 months
• Any prior administration of other research medicine/vaccine in last 30 days
• Any prior administration of any attenuated live vaccine in last 14 days
• Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent for subject's guardian

Contacts and Locations

Locations

China, Jiangsu

Pizhou City Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Sponsors and Collaborators

Jiangsu Province Centers for Disease Control and Prevention

Jiangsu Jindike Biotechnology Co., Ltd.

Investigators

• Principal Investigator: Fangyue Meng, Master; Jiangsu Province Centers for Disease Control and Prevention

More Information

• Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT05144464
• Other Study ID Numbers: JSVCT122
• First Posted: December 3, 2021
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:

Safety, Immunogenicity, Quadrivalent influenza vaccine

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases