Phase 3
N=3,196
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Avian Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02839330 ↗Enrolled (actual)
3,196
Serious AEs
7.4%
Results posted
Apr 2019
Primary outcome: Primary: Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot — 16.1; 17.0; 17.0; 128.6 geometric mean titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- aH5N1c (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot |
16.1; 17.0; 17.0; 128.6; 127.4; 132.2 | — |
| PRIMARY Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort |
13.0; 15.0; 27.8; 24.5; 95.0; 8.5 | — |
| PRIMARY Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination |
59.7; 38.0; 50.2; 14.7; 38.2; 32.8 | — |
| PRIMARY Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination |
23.4; 22.2; 7.0; 6.2; 15.3; 13.2 | — |
| PRIMARY Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group. |
6.7; 9.3; 0; 0.3; 0.5; 0.4 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). |
16.6; 16.7; 13.5; 13.7; 20.5; 20.6 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). |
22.9; 22.6; 17.4; 19.6; 28.2; 25.6 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). |
32.2; 1.1; 40.4; 1.9; 24.2; 0.3 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) |
13.0; 13.4; 20.1; 20.1; 51.1; 11.2 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) |
17.1; 19.6; 27.3; 25.0; 63.2; 12.2 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) |
42.2; 1.5; 24.6; 0.7; 81.6; 0.3 | — |
| SECONDARY Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) |
2.86; 0.80; 7.96; 0.83; 3.92; 0.85 | — |
Summary
This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.
Eligibility Criteria
Inclusion Criteria
- Subjects ≥ 18 years of age, mentally competent, in good health as determined by medical history, physical examination and clinical judgment by the Investigator; able to comply with all study procedures, to be contacted, and to be available for study visits according to the protocol.
Exclusion Criteria
- Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered.
- Females of childbearing potential who refuse to use an acceptable method of birth control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination, and, if sexually active, who have not used a reliable birth control method for at least two months prior to study entry.
- Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
- Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7 days prior to enrolment in this study or who are planning to receive any type of influenza vaccine within 7 days (before or after) from the study vaccines.
- Individuals who received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any (non-influenza) vaccine within 28 days (before or after) from the study vaccines.
- Individuals with known or suspected impairment of the immune system.
Data sourced from ClinicalTrials.gov (NCT02839330). 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.