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Phase 3 Completed N=3,094 Randomized Double-blind Prevention

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Source: ClinicalTrials.gov NCT01198756 ↗
Enrolled (actual)
3,094
Serious AEs
0.7%
Results posted
Mar 2013
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease — 362.7; 429.1; 420.2; 200.9 titer

Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Outcome Measures

OutcomeResultp-value
PRIMARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
29.4; 32.2; 29.1; 16.8; 362.7; 429.1
PRIMARY
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease
739; 755; 750; 220; 614; 590
SECONDARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
29.4; 32.2; 29.1; 16.8; 362.7; 429.1
SECONDARY
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease
480; 496; 477; 87; 850; 848
SECONDARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
12.31; 13.31; 14.42; 11.95; 7.94; 7.37
SECONDARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata
24.7; 34.6; 26.9; 38.2; 24.5; 34.2
SECONDARY
Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata
374; 365; 390; 365; 380; 370
SECONDARY
Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata
209; 271; 218; 278; 207; 270
SECONDARY
Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata
12.50; 12.12; 14.20; 12.52; 14.56; 14.29
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
637; 538; 542; 148; 35; 21
SECONDARY
Number of Days With Solicited Local Symptoms After Vaccination
2.0; 2.0; 2.0; 1.0; 2.0; 2.0
SECONDARY
Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
46; 47; 51; 102; 0; 3
SECONDARY
Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms
173; 177; 177; 6; 13; 8
SECONDARY
Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age
1.0; 2.0; 1.0; 2.0; 1.0; 1.0
SECONDARY
Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above
2.0; 1.0; 2.0; 2.0; 2.0; 2.0
SECONDARY
Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination
1.0; 1.0; 1.5; 1.0; 2.0; 1.0
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
283; 291; 275; 160; 40; 41
SECONDARY
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination
0; 1; 1; 0; 0; 0
SECONDARY
Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination
346; 335; 350; 147
SECONDARY
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
3; 6; 5; 7; 0; 0

Eligibility Criteria

Inclusion Criteria

  • Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
  • A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.
  • Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
  • Written informed assent obtained from the subject if/as required by local regulations.
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject
  • Has practiced adequate contraception for 30 days prior to vaccination, and
  • Has a negative pregnancy urine test on the day of vaccination, and
  • Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria

  • Child in care
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Fever at the time of enrolment.
  • Acute disease at the time of enrolment.
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Ongoing aspirin therapy.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01198756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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