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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972816
First Posted: September 9, 2009
Last Update Posted: April 14, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
September 2, 2009
September 9, 2009
December 6, 2010
January 27, 2011
April 14, 2016
September 2009
November 2009   (Final data collection date for primary outcome measure)
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations [ Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387 ]

HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.

PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.

PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.

HI antibody responses after 1 and/or 2 vaccinations [ Time Frame: 21 days after each vaccination ]
Complete list of historical versions of study NCT00972816 on ClinicalTrials.gov Archive Site
  • Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group [ Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387 ]

    Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.

    PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.

    PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

  • Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. [ Time Frame: Day 22, Day 29, Day 43 ]
    HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
  • Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [ Time Frame: Day 1, Day 22, Day 29, Day 43 ]

    Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines

    Subgroups without recent seasonal flu vaccine:

    PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.

    PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.

    Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.

    PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively

  • Antibody Response Based on Baseline Seropositivity [ Time Frame: Day 22, Day 29 and Day 43 ]

    Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

    Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.

    Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.

  • Geometric Mean Titers (GMTs) Based on Baseline Seropositivity [ Time Frame: Day 1, Day 22, Day 29, Day 43 ]

    Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

    Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).

  • Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination [ Time Frame: 7 days after first vaccination ]
    Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
  • Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination [ Time Frame: 7 days after second vaccination ]
    Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
  • Number of Participants Reporting Unsolicited Adverse Events (AEs) [ Time Frame: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination ]
    Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Surveillance for solicited local & systemic reactions & AEs during treatment period & surveillance for 21 d after each study vacc, & SAE, medically attended visits, new onset of chronic diseases will be collected through the treatment & follow-up periods [ Time Frame: 12 months following last vaccination ]
Not Provided
Not Provided
 
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Influenza
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
  • Experimental: 3.75_(50)MF59
    3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 7.5_(0) MF59
    7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 7.5_(50) MF59
    7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 7.5_(100) MF59
    7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 15_(0) MF59
    15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 15_(50)MF59
    15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 15_(100) MF59
    15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
  • Experimental: 30_(0) MF59
    30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
    Intervention: Biological: MF59-eH1N1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1357
October 2010
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

  • History of serious disease.
  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
  • Known or suspected impairment/alteration of immune function.
  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

For additional entry criteria, please refer to protocol.

Sexes Eligible for Study: All
3 Years to 8 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico,   United States
 
 
NCT00972816
V112_02
No
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Director: Novartis Vaccines and Diagnostics Novartis
Novartis
March 2016

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