Prime-boost immunisation of healthy subjects aged 3 to 17 years against pandemic H5N1 influenza.
Conditions
Interventions
Product Name: H5N1 A/turkey/Turkey/01/2005 with AS03B
Product Code: GSK1562902A
Pharmaceutical Form: Emulsion and suspension for emulsion for injection
Other descriptive name: A/Turkey/Turkey/01/2005
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: • Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol . • A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination. • Written informed consent obtained from the subject’s parent or guardian. Assent obtained from the subject when applicable. • Good general health as established by medical history and clinical examination before entering into the study. • Comprehension by the subject’s parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits. • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments). • 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 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. Are the trial subjects under 18? yes Number of subjects for this age range: 520 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: • Child in care • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration. • Active participation in other clinical trials. • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed. • Acute disease and/or fever at the time of enrolment: • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. • Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period. • Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine. • History of seizures or progressive neurological disease. • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions. • Diagnosed with cancer or any chronic severe disease. • Previous administration of any H5N1 vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Co-primary Immunogenicity Objective • To assess the superiority of the haemagglutination inhibition (HI) antibody response against A/turkey/Turkey/01/2005 (H5N1) 10 days following H5N1 vaccination at Day 182 [1.9 µg A/turkey/Turkey/01/2005 (H5N1) HA antigen adjuvanted with AS03B] in subjects previously primed with 2 doses of heterologous A/Indonesia/5/2005 (H5N1) vaccine (Group H5N1_H5N1) versus non primed subjects (Group Havrix_H5N1). Co-primary Safety Objective • To evaluate the safety of the paediatric H5N1 vaccine when administered as a 2-dose primary vaccination to subjects 3 to 17 years of age in terms of occurrence of medically attended adverse events (MAEs) from Day 0 to Day 182 and to the Day 364 visit.;Secondary Objective: Immunogenicity • To assess the HI antibody response in terms of seropositivity rates, GMTs, SCR, SPR and MGI, against A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 (H5N1) strains: at Days 0, 42 and 182 (all subjects), at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1) and Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). • To further describe the humoral immune responses in terms of the age strata used for enrolment in this study. • To describe the H5N1 neutralising antibody responses against the A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 strains at Days 0, 42, 182 (all subjects), 192 (groups H5N1_H5N1 and H5N1_Havrix) and 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). Safety • To evaluate, after each vaccination, safety and reactogenicity in terms of 7-day solicited local and general symptoms, unsolicited adverse events (AEs) for 21 days after each dose and Day 0 to Day 84 overall, and pIMDs and SAEs during the entire study.;Primary end point(s): Primary immunogenicity endpoint • Humoral immune response in terms of H5N1 HI antibodies against the A/turkey/Turkey/01/2005 (H5N1) strain: Observed variables: ? H5N1 HI antibody titres against the A/turkey/Turkey/01/2005 (H5N1) strain at Day 192. Derived var | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Immunogenicity: Days 0, 42, 182, 192, 364 Safety Solicited Local and general symptoms: During a 7-day (Day 0-6) follow-up period after each vaccination. Unsolicited local and general symptoms: During a 21-day (Day 0-20) follow-up period after each vaccination and from Day 0 to Day 84. Potential Immune-mediated Diseases: During the entire study period (Day 0 to 364). Serious Adverse events: During the entire study period (Day 0 to 364). ;Secondary end point(s): Secondary immunogenicity endpoints • Humoral immune response in terms of H5N1 HI antibodies against the A/Indonesia/5/2005 and A/turkey /Turkey/01/2005 (H5N1 virus) strains. Observed variable: ? H5N1 HI antibody titres at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). Derived variables: ? Geometric means titres (GMTs) and seropositivity rates of H5N1 HI antibody titres at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1) and Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). ? Seroconversion rate (SCR) at Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). ? Seroprotection rates (SPR) at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). ? Mean Geometric Increase (MGI) at Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). ? Booster-Seroconversion rates (Booster SCR) at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1). ? Booster factor (BF) at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day | — |
Countries
Philippines
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed