A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks. - FLU D-PAN H1N1-012

Phase 1

Conditions: Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.

Registration Number: EUCTR2009-015174-35-NO

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
-Children, male or female, aged between 8 and 12 weeks 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 when entering 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.
-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
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
;
-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
-Children, male or female, aged between 8 and 12 weeks 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 when entering 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.
-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
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
;
-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
-Children, male or female, aged between 8 and 12 weeks 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 when entering 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.
-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
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

-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.
-Acute disease at the time of enrolment.
-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
-History of any neurological disorders or seizures.
-A family history of congenital or hereditary immunodeficiency.
-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
-Administration of any vaccines within two weeks before study enrolment.
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
-Major congenital defects or serious chronic illness.
-Child in care.
-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
;
-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.
-Acute disease at the time of enrolment.
-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
-History of any neurological disorders or seizures.
-A family history of congenital or hereditary immunodeficiency.
-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
-Administration of any vaccines within two weeks before study enrolment.
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
-Major congenital defects or serious chronic illness.
-Child in care.
-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
;
-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.
-Acute disease at the time of enrolment.
-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
-History of any neurological disorders or seizures.
-A family history of congenital or hereditary immunodeficiency.
-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
-Administration of any vaccines within two weeks before study enrolment.
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
-Major congenital defects or serious chronic illness.
-Child in care.
-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.