Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months

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 Aged 6~35 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020628
• Other study ID #: NBP607-QIV_FluC_III_2016
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2017
• Last updated: October 31, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6~35 months.

Description:

Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. 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: 171
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria:

• Children aged 6 months to 35 months

• 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 with immune deficiency disorder or malignant cancer.

• History of any hypersensitivity following administration of vaccine or 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 received any other investigational products within 4 weeks prior to study vaccination.

• Subjects with clinically significant chronic disease.

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• NBP607-QIV
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
• NBP607-TIV
For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]

Locations

Country	Name	City	State
Korea, Republic of	Korea University ANSAN hospital	Ansan
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Gachon University Gil Medical center	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon ST. Mary's Hospital	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Seoul
Korea, Republic of	Korea Institute of Radiological and Medical Science	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%	Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer = 1:40	At Day 28 post-vaccination
Primary	HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%	Seroconversion is defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer = 1:40, and a significant increase was defined as at least a four fold increase in HI titer	At Day 28 post-vaccination
Primary	HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5	GMR [geometric mean ratio, mean fold increase]	At Day 28 post-vaccination