Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.
Conditions
Interventions
Trade Name: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
A/Califomia/7/2009 (H1N1)v like strain (X-179A) (Pandemrix)
Pharmaceutical Form: Emulsion for injection
INN or Pro
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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 ;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 ;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
Exclusion criteria
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. ;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. ;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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks post Dose 1.;Secondary Objective: To evaluate the vaccine homologous HI antibody response after each vaccination dose of the H1N1 candidate vaccine administered either as a 0-28 day or 0-4 month schedule in terms of GMTs, SCRs, SPRs and SCFs. To evaluate the neutralising antibody response after each vaccination dose of the H1N1 candidate vaccine administered either as a 0-28 day or 0-4 month schedule in terms of GMTs, SCRs, SPRs and SCFs, at each blood sampling time point. To assess the immunogenicity of the routine infant immunisation after 2-dose primary vaccination at Month 4 and after booster vaccination at Month 11 when given according to the national recommended routine immunisations. To evaluate the safety and reactogenicity of the H1N1 candidate vaccine after each vaccination dose in terms of 7-day solicited local and general symptoms, and 28-day post Dose 1 and 2 unsolicited AEs. Medically attended AEs, adverse events of specific interests, and SAEs will be reported during the whole study period.;Primary end point(s): Safety and reactogenicity evaluation: Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms, unsolicited AEs and SAEs two weeks post Dose 1, i.e., day of vaccination and 13 subsequent days at Visit 1 (Day 0).;Main Objective: To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks post Dose 1.;Secondary Objective: To evaluate the vaccine homologous HI antibody response after each vaccination dose of the H1N1 candidate vaccine administered either as a 0-28 day or 0-4 month schedule in terms of GMTs, SCRs, SPRs and SCFs. To evaluate the neutralis | — |
Countries
Norway
Contacts
Public Contact;; ;;
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Outcome results
None listed