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OpenTrials
Completed

NCT Number: NCT00996138

Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

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Key information

Conditions

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

Age range

29 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Osaka pref.

Kagoshima Pref., Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Japanese adults aged 20 to 60 years

Exclusion criteria

  • History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
  • Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
  • Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
  • History of progressive or severe neurological disorders

Treatment and study plan

Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine

Biological

High dose group and low dose group of adjuvanted vaccines

Primary outcomes

  1. Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6

    Time frame: 6 weeks

Secondary outcomes

  1. AEs, vital signs, laboratory tests

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 16, 2009
Registry last updated
Dec 1, 2016

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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