Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

Influenza, Human Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children and Adolescents Aged 6 Months ~ 18 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621164
• Other study ID #: NBP607-QIV_FluC_III_2014
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2015
• Last updated: December 1, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Description:

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Children and adolescents aged 6 months to 18 years.

• Those who was born after normal pregnancy period(37 weeks) for aged 6 months to < 1 year

• Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Exclusion Criteria:

• Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.

• Subjects with immune deficiency disorder or malignant cancer.

• History of Guillain-Barre syndrome.

• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

• Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0?) on screening day.

• Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.

• Subjects who had received blood products or immunoglobulin within 3 months before screening.

• Subjects who had received influenza vaccination within 6 months prior to the screening.

• Subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination.

• Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.

• Subjects with clinically significant chronic disease.

• Pregnant women, breast-feeding women.

• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• NBP607-QIV
For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
• Agrippal S1
For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHMP criteria	Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5	At Day 28 post-vaccination	No
Secondary	Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80		At Day 28 post-vaccination	No
Secondary	Immunogenicity compared to control group		At Day 28 post-vaccination	No
Secondary	Incidence rate of Advers Event (AE)	Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE	During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE	Yes
Secondary	Incidence rate of Severe Adverse Event (SAE)		During 6 months post-vaccination	Yes
Secondary	Vital Sign		At Day 0 and at Day 28 post-vaccination	Yes
Secondary	Physical Examination		At Day 0 and at Day 28 post-vaccination	Yes