Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01196988
• Date of registration: 07/09/2010
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
• Scientific title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children
• Date of first enrolment: October 2010
• Target sample size: 3027
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01196988
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Czech Republic, France, Germany, Philippines, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.

- For non US countries:

- - Children, male or female, aged between 6 months and 17 years at the time of the
first study vaccination.

For US :

- 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.

- Subjects in stable health as determined by investigator's clinical examination and
assessment of subjects' medical history.

- Written informed assent obtained from the subject if/as required by local
regulations.

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the
subject:

- - has practiced adequate contraception for 30 days prior to vaccination,

- - and has a negative urine pregnancy test on the day of vaccination,

- - and has agreed to continue adequate contraception during the entire treatment
period and for 2 months after completion of the vaccination series

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. Routine registered childhood vaccinations are permitted.

- Planned administration of any vaccine 30 days prior and 30 days after any study
vaccine administration.

- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by medical history and physical examination.

- Prior receipt of any seasonal or pandemic influenza vaccine (registered or
investigational) within 6 months preceding the first dose of study vaccine, or
planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
three months prior to enrolment in this study or planned administration during the
study period.

- Administration of immunoglobulins and/or any blood products within the three months
prior to the enrolment in this study, or planned during the study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- History of seizures or progressive neurological disease.

- History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated
influenza virus vaccine.

- Concurrently participating in another clinical study, at any time during the study
period in which the subject has been or will be exposed to an investigational or a
non-investigational product .

- History of hypersensitivity to a previous dose of influenza vaccine, history of any
reaction or hypersensitivity likely to be exacerbated by any component of the
vaccines

- Acute disease and/or fever at the time of enrolment

- Ongoing aspirin therapy

- Pregnant or lactating female

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.

- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study

- Child in Care.



Age minimum: 6 Months
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: FluarixTM

Biological: Influenza vaccine GSK2321138A

Biological: Influenza vaccine GSK2604409A

Primary Outcome(s)

Humoral immune response in terms of Haemagglutination inhibition (HI) antibodies (per treatment group). [Time Frame: Day 0]

Humoral immune response in terms of HI antibodies (per treatment group). [Time Frame: 28 days after vaccination.]

Secondary Outcome(s)

Humoral immune response in terms of HI antibodies [Time Frame: Day 0 and 28 days after vaccination.]

Occurrence of AEs with medically attended visits [Time Frame: From the beginning (Day 0) up to the study end (Day 180)]

Occurrence of potential immune mediated diseases and serious adverse events [Time Frame: From the beginning (Day 0) up to the study end (Day 180)]

Occurrence of solicited local and general symptoms [Time Frame: During a 7-day (Day 0 to 6) follow-up period after each vaccination]

Occurrence of unsolicited adverse events (AEs) [Time Frame: During a 28-day (Day 0 to 27) follow up period after each vaccination]

Secondary ID(s)

113275

Source(s) of Monetary Support

Please refer to primary and secondary sponsors