Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children

NCT ID: NCT01003418

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-17
• Study Completion Date: 2010-11-25

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2340272A Group 1

Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.

Group Type: EXPERIMENTAL

GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Intervention Type: BIOLOGICAL

Two doses; intramuscular administration

Infanrix™-IPV/Hib

Intervention Type: BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

Prevenar

Intervention Type: BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

GSK2340272A Group 2

Healthy male or female children, between and including 8 and 12 weeks of age at the time of first vaccination, received 2 primary doses of GSK2340272A vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (Infanrix™-IPV/Hib) and Prevenar™ vaccine at Day 14, Month 3 and Month 10. All vaccines were administered intramuscularly into the anterolateral region of the thigh.

Group Type: EXPERIMENTAL

GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Intervention Type: BIOLOGICAL

Two doses; intramuscular administration

Infanrix™-IPV/Hib

Intervention Type: BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

Prevenar

Intervention Type: BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

Interventions

GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Two doses; intramuscular administration

Intervention Type: BIOLOGICAL

Infanrix™-IPV/Hib

Routine infant immunisation vaccine, three doses administered intramuscularly

Intervention Type: BIOLOGICAL

Prevenar

Routine infant immunisation vaccine, three doses administered intramuscularly

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) 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 of >= 36 to <= 42 weeks.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• 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.
• Acute disease at the time of enrolment.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• 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.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bergen, , Norway

GSK Investigational Site

Hønefoss, , Norway

GSK Investigational Site

Lierskogen, , Norway

GSK Investigational Site

Oslo, , Norway

Countries

Norway

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113629

Identifier Type: -

Identifier Source: org_study_id