Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

Novartis

Status and phase: Completed; Phase 1

Conditions: H7N9 Influenza

Treatments: Biological: H7N9c low dose with adjuvant; Biological: H7N9c medium dose with adjuvant; Biological: H7N9c high dose without adjuvant; Biological: H7N9c high dose with adjuvant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01928472

V131_01

Details and patient eligibility

About

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Enrollment: 402 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult subject ages 18-64 years.
2. Individuals willing to provide written informed consent
3. Individuals in good health.
4. Individuals who can comply with study procedures and follow-up.

Exclusion criteria

1. Individuals with history of cognitive or behavioral impairment or psychiatric disease,
2. Individuals unable to understand and follow study procedures,
3. History of significant illness,
4. History of chronic medical condition or progressive disease,
5. Allergy to any vaccine component or adverse event related to a vaccine component,
6. Impairment/alteration of the immune system,
7. Presence of progressive or severe neurological disorder,
8. Pregnant or breast-feeding,
9. Female of Child-bearing potential unwilling to use acceptable method of birth control,
10. Presence of medically significant cancer,
11. Receipt of investigational product within 30 day prior to entry into the study,
12. History of previous or suspected illness from avian flu caused by H7N9 virus,
13. History of H7 vaccination,
14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
17. History of drug or alcohol abuse within the past 2 years,
18. Body Mass Index (BMI) greater than or equal to 35kg/m2,
19. Individuals conducting the study or their immediate family members.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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402 participants in 4 patient groups

Group A

Experimental group

Description:

H7N9c low dose with adjuvant

Treatment:

Biological: H7N9c low dose with adjuvant

Group B

Experimental group

Description:

H7N9c medium dose with adjuvant

Treatment:

Biological: H7N9c medium dose with adjuvant

Group C

Experimental group

Description:

H7N9c high dose with adjuvant

Treatment:

Biological: H7N9c high dose with adjuvant

Group D

Experimental group

Description:

H7N9c high dose without adjuvant

Treatment:

Biological: H7N9c high dose without adjuvant