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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000207
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 22, 2009
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
AEs, vital signs, laboratory tests [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
Official Title  ICMJE 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 Pediatric Subjects
Brief Summary 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 children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.
Detailed Description This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were randomized at a 1:1 ratio to receive either 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) or 7.5μg of cell-derived H1N1sw vaccine formulated with full MF59 (7.5_fullMF59). Subjects were not informed of their allocated doses. Two vaccinations were administered IM three weeks apart. Subjects in both the vaccine groups were stratified into three age strata: 6 to 35 months, 3 to 8 years and 9 to 19 years. Blood samples were collected at day 1 (baseline), three weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays. 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 adverse events (AE), serious adverse events (SAE), and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Swine-Origin Influenza A H1N1 Virus
Intervention  ICMJE Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
High dose group and low dose group of adjuvanted vaccines
Study Arms  ICMJE
  • Experimental: 1
    Dose ranging
    Intervention: Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
  • Experimental: 2
    Dose ranging
    Intervention: Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
Publications * Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Sawata H, Nakura N, Jaeger RK, Lattanzi M. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Adv Ther. 2010 Jul;27(7):444-57. doi: 10.1007/s12325-010-0043-4. Epub 2010 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
123
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2009)
120
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Japanese aged 6 months to 19 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000207
Other Study ID Numbers  ICMJE V110_08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP