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Completed

NCT Number: NCT02621164

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

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.

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Key information

Conditions

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

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBP607-QIV

Biological

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

Biological

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)

Primary outcomes

  1. CHMP criteria

    Time frame: At Day 28 post-vaccination

    Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5

Secondary outcomes

  1. Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80

    Time frame: At Day 28 post-vaccination

  2. Immunogenicity compared to control group

    Time frame: At Day 28 post-vaccination

  3. Incidence rate of Advers Event (AE)

    Time frame: During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE

    Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE

  4. Incidence rate of Severe Adverse Event (SAE)

    Time frame: During 6 months post-vaccination

  5. Vital Sign

    Time frame: At Day 0 and at Day 28 post-vaccination

  6. Physical Examination

    Time frame: At Day 0 and at Day 28 post-vaccination

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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