Immunisation of healthy children aged 3 to 17 years against the novel H1N1 influenza.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g.,, completion of the diary cards, return for follow-up visits, be available for telephone/fax contacts). • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination. • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable. • Healthy children as established by medical history and clinical examination when entering into the study. • 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). Are the trial subjects under 18? yes Number of subjects for this age range: 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 (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. • Clinically or virologically confirmed influenza infection within six months preceding the study start. • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • Acute disease and/or fever at the time of enrolment: ? Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting. ? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • 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. • Previous administration of any H1N1 A/California-like vaccine. • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination. • Child in Care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral immune response after two primary administrations of the candidate H1N1 pandemic vaccine that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR) and geometric mean fold rise (GMFR) at 21 days after the second dose of H1N1 vaccine in children aged 3 to 17 years. To evaluate the superiority in terms of vaccine virus homologous haemagglutination inhibition (HI) antibody response of a single dose of the H1N1 candidate vaccine administered as a 6-month booster after 2-dose primary vaccination compared to the response after the first dose of primary vaccination. Criteria for success: ? If the lower limit of the two-sided 95% confidence interval (CI) for the geometric mean titre (GMT) ratio (at seven days after a 6-month booster after 2 dose primary vaccination/21 days after the first dose) is > 2.0. ;Secondary Objective: To assess the vaccine homologous HI antibody response at 21 days after the 1st and the 2nd dose primary vaccinations and at Month 6. To assess the vaccine homologous HI antibody response in terms of GMT SCR SPR and SCF 7 days, 6 months after the booster administration. To further describe the humoral immune responses in terms of the 3 age strata used for enrolment in this study. To describe the humoral immune response in terms of H1N1 neutralising antibodies at each time point, in a subset of one third of the subjects’ samples. To evaluate the safety in terms of ALT, AST, BILI, BUN and CREA on Day 0, Day 21, Day 42, at Month 6 and Month 6+7 Days. To evaluate after the primary vaccinations and the booster administration, the safety and reactogenicity of the H1N1 candidate vaccine in terms of 7-day solicited local and general symptoms 21D post Dose 1, 63D post Dose 2 and 30D post-booster dose unsolicited AEs. To describe MAEs AESIs/pIMDs and SAEs during the whole study period. ;Primary end point(s): • For the humoral immune response in terms of v | — |
Countries
Germany
Outcome results
None listed