Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

Swine-Origin Influenza A H1N1 Virus Clinical Trial

Official title:

Open-label, Uncontrolled Postmarketing Study to Evaluate Immunogenicity, Safety and Tolerability of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069367
• Other study ID #: V110_10
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2010
• Last updated: November 30, 2016
• Start date: March 2010
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety & tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.

Description:

This is an open-label, uncontrolled post-marketing study of the cell-derived A/H1N1 influenza HA vaccine. Subjects received 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59). All vaccination were administered IM in the deltoid muscle, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. Blood samples were collected at baseline (day1), 3 weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) assay. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e. Day 1 to Day 7 and Day 22 to Day 28). All AEs, SAEs, and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 61 Years and older

Eligibility

Inclusion Criteria:

• Healthy Japanese aged over 60 years

Exclusion Criteria:

• Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease)

• History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients

• Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease

• History of progressive or sever neurological disorders

• Known or suspected impairment/alteration of immune function

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Swine-Origin Influenza A H1N1 Virus

Intervention

Biological:
• Emulsion, Cell Culture-based, influenza HA vaccine H1N1
Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)

Locations

Country	Name	City	State
Japan	CPC Clinic, Medipolis Medical Research Institute	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Fukase H, Furuie H, Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Yotsuyanagi H, Kusadokoro H, Sawata H, Nakura N, Lattanzi M. Assessment of the immunogenicity and safety of varying doses of an MF59®-adjuvanted cell culture-derived A/H1N1 pandem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6		6 weeks	Yes
Secondary	Solicited reactions, AEs, vital signs, laboratory tests		6 weeks	Yes

External Links

•   Results for V110_10 from the Novartis Clinical Trials website