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Phase 1 N=627 Randomized Quadruple-blind Prevention

Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.

Prophylaxis of A/H3N2v Influenza

Bottom Line

View on ClinicalTrials.gov: NCT01855945 ↗
Enrolled (actual)
627
Serious AEs
2.9%
Results posted
Feb 2016
Primary outcome: Primary: Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. — 31; 36; 18; 24 Number of Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Swine Influenza (Biological)
Age
Pediatric, Adult, Older Adult · 3+ yrs
Sex
All
Sponsor
Novartis Vaccines
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.		 31; 36; 18; 24; 25; 22 —
PRIMARY
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.		 37; 40; 35; 30; 24; 27 —
PRIMARY
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.		 30; 40; 27; 21; 28; 21 —
PRIMARY
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.		 23; 29; 15; 14; 17; 14 —
PRIMARY
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.		 0; 1; 0; 0; 0; 1 —
PRIMARY
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.		 96; 98; 71; 88; 98; 85 —
PRIMARY
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.		 8; 7; 14; 45; 59; 49 —
SECONDARY
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).		 8.48; 8.26; 8.8; 28; 29; 27 —
SECONDARY
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.		 22; 33; 11; 14; 15; 13 —
SECONDARY
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.		 8; 7; 14; 45; 59; 49 —
SECONDARY
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.		 96; 98; 71; 89; 98; 85 —
SECONDARY
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.		 8; 7; 14; 44; 59; 49 —
SECONDARY
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.		 22; 33; 11; 14; 15; 13 —

Summary

Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly 65 years and older.

Eligibility Criteria

Inclusion Criteria

  • Males and females 3 years of age and older
  • Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
  • Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
  • Individuals who can comply with study procedures and are available for follow-up

Exclusion Criteria

  • Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
  • Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
  • Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
  • Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
  • Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
  • Individuals with known or suspected impairment of the immune system including, but not limited to:
  • autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
  • autoimmune disorders;
  • Systemic therapy with corticosteroids or other immunosuppressive therapy.
  • Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study
  • Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
  • If female, "of childbearing potential", sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
  • "Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy
  • Acceptable birth control methods are defined as one or more of the following:
  • Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
  • Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
  • Intrauterine device (IUD);
  • Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
  • If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
  • Individuals who are allergic to any of the vaccine components.
  • For children 17 years of age and younger: Individuals who have had ever a malignancy
  • For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
  • Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
  • Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3 days of intended study vaccination
  • Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
  • Individuals who have received any prior H3N2v vaccine
  • Individuals who have received any other type of influenza vaccination (e.g., "seasonal") within 14 day
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01855945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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