A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months

NCT05212623 | Completed Phase 1 DMC

• 1 other identifier: LGYM（SJ）-2021-I
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in children aged 6 to 35 months. About 120 healthy participants are planned to be enrolled, of who 60 participants were enrolled in the low-dose group and 60 participants were enrolled in the high-dose group. In the low-dose group, participants were randomly (2:1:1) assigned to receive a quadrivalent inactivated influenza vaccine (IIV4) at 0.25 mL including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, and a trivalent inactivated influenza vaccine (IIV3) at 0.25 mL including A/H1N1, A/H3N2 and B/Victoria, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. In the high-dose group, participants were randomly (2:1:1) assigned to receive IIV4 at 0.5 mL, and IIV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Victoria, and IV3 at 0.25 mL including A/H1N1, A/H3N2, and B/Yamagata. Subjects receive 2 doses of influenza vaccine 4 weeks apart. The occurrence of adverse reactions within 30 minutes, the occurrence of adverse reactions within 28 days, and serious adverse events within 6 months after vaccination will be observed in all participants. For participants aged 24-35 months in each dose group, laboratory safety tests were measured before enrollment and on day 4 post each dose to assess any toxic effects. In addition, all subjects will be required to collect blood for HI antibody testing before the first dose of vaccination and 30 days after the second dose of vaccination.

Conditions

Influenza

Keywords

Influenza; quadrivalent influenza split vaccine; reactogenicity; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)

  Incidence of adverse events within 7 days after each vaccination in the participants aged 6-35 months. (Including abnormal laboratory test indicators and clinical significance)

  On day 7 after each dose

Secondary Outcomes (6)

• Incidence of adverse events from the first dose to 30 days after the second dose in the participants aged 6-35 months.

  Time Frame: within 30 days after the second dose

• Incidence of serious adverse events (SAE) till the 6 months after the second dose in the participants aged 6-35 months.

  within 6 months after the second dose

• HI antibody-positive conversion rate in each group 30 days after the second vaccination in the participants aged 6-35 months.

  on day 30 after the second vaccination

• Seroprotection rate 30 days after the second dose in each group in the participants aged 6-35 months.

  on day 30 after the second vaccination

• GMT of HI antibodies 30 days after the second dose of each group in the participants aged 6-35 months.

  on day 30 after the second vaccination

Study Arms (4)

Group A

EXPERIMENTAL

Subjects received 2 doses of 0.25 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata).

Biological: quadrivalent influenza split vaccine

Group B

EXPERIMENTAL

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.(Four types of virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata).

Biological: quadrivalent influenza split vaccine

Group C

ACTIVE COMPARATOR

Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 type of virus strains, including BY).

Biological: Influenza virus split vaccine

Group D

ACTIVE COMPARATOR

Subjects received 2 doses of 0.25 mL of influenza vaccine, 4 weeks apart. Each 0.25-ml dose contained 7.5 μg of hemagglutinin per strain (3 types of virus strains, including BV).

Biological: Influenza virus split vaccine

Interventions

quadrivalent influenza split vaccine BIOLOGICAL

This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

Group A

Influenza virus split vaccine BIOLOGICAL

This vaccine is produced by Changchun Sponsor Institute of Biological Products Co., Ltd. Subjects will receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

Group C

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants and young children aged 6-35 months, provide vaccination certificate and birth medical certificate.
• The subject or legal guardian can provide with informed consent and sign the informed consent form.
• The subjects or legal guardians are able to and willing to use a thermometer, a scale and fill in a diary card/contact card as required, and be able to comply with the requirements of the clinical trial protocol to complete clinical research.

You may not qualify if:

• st dose:
• Axillary temperature\>37.0℃
• Participants aged 24-35 months, with abnormal blood routine, blood biochemical and urine routine indexes and judged by the researchers as having clinical significance.
• Influenza within the past 3 months (confirmed clinically, serologically or microbiological).
• Have previously received any influenza vaccine (registered or experimental) or planned to receive any influenza vaccine during the study.
• Allergy to any component of the study vaccine, history of allergic reaction to eating eggs or using gentamicin sulfate.
• History of severe allergies to any vaccines or drugs.
• Preterm (delivered before 37 weeks of gestation), low birth weight (birth weight \<2500g) infants (only for volunteers aged 6 months to 12 months).
• Dystocia, suffocation rescue, nervous system damage history.
• Congenital malformations or developmental disorders affecting organ function, genetic defects, severe malnutrition, etc..
• Acute illness, severe chronic illness, or acute exacerbation of chronic illness on the day of vaccination.
• History of vaccination with the live attenuated vaccine within 14 days prior to vaccination and other vaccination within 7 days.
• Those receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
• Have congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
• History of asthma, unstable in the past two years requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Changchun Institute of Biological Products Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Province Centers for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: October 26, 2021
• Primary Completion: January 17, 2022
• Study Completion: June 16, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-03

Locations

CN (1)