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NCT Number: NCT00996307

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

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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

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tlalpan, Mexico City, Mexico

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children 6 to 35 months 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

Treatment and study plan

MF59-eH1N1_f

Biological

3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Primary outcomes

  1. Antibody Responses After the First and Second Vaccinations

    Time frame: 21 days after each vaccination

    CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.

  2. Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination

    Time frame: Day 1 to 7

    Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.

  3. Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination

    Time frame: Day 22 to 28

    Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.

Secondary outcomes

  1. Immunogenicity Measurement by Geometric Mean Titers (GMT)

    Time frame: 21 days after each vaccination

    Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.

  2. Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010

    Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)

    Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.

  3. Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010

    Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)

    Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.

  4. Antibody Response Based on Baseline Seropositivity

    Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)

    Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10

  5. Geometric Mean Titers (GMTs) Based on Baseline Seropositivity

    Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)

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

  6. Antibody Persistence by Geometric Mean Titers (GMT)

    Time frame: 6 months (Day 202) and 12 months (Day 387) after second vaccination

    Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Novartis

Registry information

Official study title

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 16, 2009
Registry last updated
May 30, 2017

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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