Immunisation of healthy children aged 6 to 35 months against H5N1 influenza.
Conditions
Interventions
Product Name: H5N1 A/turkey/Turkey/1/2005 with AS03B
Product Code: GSK1562902A
Pharmaceutical Form: Emulsion and suspension for emulsion for injection
Other descriptive name: A/Turkey/Turkey/1/2005 (H
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol. • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination. • Written informed consent obtained from the parent(s)/LAR(s) of the subject. • Healthy children as established by medical history and clinical examination before entering the study. • Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device. • Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited. Are the trial subjects under 18? yes Number of subjects for this age range: 120 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: • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days 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. • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • History of any neurological disorders or seizures. • Acute disease at the time of enrolment. • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period. • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. • Child in care. • Previous vaccination at any time with an H5N1 vaccine. • Medical history of physician-confirmed infection with a H5N1 virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Humoral immune response in terms of H5N1 HI antibodies against A/turkey/Turkey/1/2005 H5N1 virus strain. Observed variable: H5N1 HI antibody titres against A/turkey/Turkey/1/2005 H5N1 virus strain on Day 192. ;Main Objective: To assess whether a heterologous booster dose of 1.9 µg A/turkey/Turkey/1/2005 (H5N1) HA with AS03B given 6 months following a 2-dose primary vaccination series with 1.9 µg A/Indonesia/05/2005 (H5N1) HA with AS03B elicits an antibody response that meets the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guidance targets for pre-pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR) and mean geometric increase (MGI) based on HI responses to A/turkey/Turkey/1/2005 (H5N1) ten days following booster vaccination.;Secondary Objective: • To assess the HI response against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 strains in terms of seropositivity rates, geometric mean titres (GMTs), SCRs, SPRs and MGIs on Day 0, Day 42, Day 182, Day 192 and Day 364. • To further describe the humoral immune responses in terms of the three age strata used for enrolment in this study. • To describe, in all subjects, the H5N1 neutralising antibody responses against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 strains on Day 0, Day 42, Day 182, Day 192 and Day 364. • To evaluate, after the primary vaccinations and the booster administration, the safety and reactogenicity of the H5N1 vaccines in terms of 7-day solicited local and general adverse events (AEs), unsolicited AEs for 21 days after each dose and from Day 0 to the phone call on Day 84 overall, and medically-attended AEs (MAEs), potential Immune-Mediated Diseases (pIMDs), and serious adverse events (SAEs) during the entire study. ;Timepoint(s) of evaluation of this end point: On Day 192 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Humoral immune response in terms of H5N1 HI antibodies against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 H5N1 virus strains. Observed variable: • H5N1 HI antibody titres against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 virus strains on Day 0, Day 42, Day 182, Day 192 and Day 364. Humoral immune response in terms of neutralising antibodies against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 H5N1 virus strains: Observed variable: • Serum neutralising antibody titres against A/Indonesia/05/2005 and A/turkey/Turkey/1/2005 virus strains on Day 0, Day 42, Day 182, Day 192 and Day 364. For the safety and reactogenicity evaluation: • Percentage, intensity and relationship to vaccination of solicited local and general AEs during a 7-day follow-up period, i.e. day of vaccination and six subsequent days after each vaccination on Day 0, Day 21 and Day 182. • Percentage, intensity and relationship to vaccination of unsolicited AEs during a 21-day follow-up period after each vaccination and from Day 0 to Day 84 overall. • Occurrence of MAEs during the entire study period. • Occurrence of pIMDs during the entire study period. • Occurrence of SAEs during the entire study period. ;Timepoint(s) of evaluation of this end point: Immunogenicity with respect to components of the investigational vaccine - On Day 0, Day 42, Day 182, Day 192 and Day 364. Immunogenicity with respect to components of the investigational vaccine in terms of neutralising antibodies - On Day 0, Day 42, Day 182, Day 192 and Day 364. Occurrence of solicited local and general adverse events - During a 7-day (Day 0-6) follow-up period after each vaccination. Occurrence of unsolicited AEs - During a 21-day (Day 0-20) follow-up period after each vaccination and from Day 0 to Day 84 overall. Occurrence of medically-attended adverse events (MAEs), potential Immune-Mediated Diseases (pIMDs) and serious adverse events (SAEs) - During the entire study period | — |
Countries
Australia, Singapore
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed