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Clinical Trials/EUCTR2009-015174-35-NO
EUCTR2009-015174-35-NO
Active, not recruiting
Phase 1

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

GlaxoSmithKline Biologicals0 sitesOctober 8, 2009
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ConditionsImmunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.
DrugsPandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.
Sponsor
GlaxoSmithKline Biologicals
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 8, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

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.

Outcomes

Primary Outcomes

Not specified

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