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

NCT01003418 | Terminated Phase 2 Results

• 1 other identifier: 113629
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

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

Keywords

GSK2340272A; H1N1 pandemic influenza

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Any Solicited Local or General Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.

  During the 7-days post-Dose 1 period (Days 0-6)

• Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.

  During the 2-weeks post-Dose 1 period (Days 0-13)

• Number of Subjects With Serious Adverse Events (SAEs)

  SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

  During the 2-weeks post-Dose 1 period (Days 0-13)

Secondary Outcomes (3)

• Number of Subjects With Any Solicited Local or General Symptoms

  During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)

• Number of Subjects With Any, Grade 3 and Related Unsolicited AEs

  During the 28-day (Days 0-27) follow-up period after each study vaccine administration

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period (From Month 0 up to Month 11)

Study Arms (2)

GSK2340272A Group 1

EXPERIMENTAL

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.

Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Biological: Infanrix™-IPV/Hib; Biological: Prevenar

GSK2340272A Group 2

EXPERIMENTAL

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.

Biological: GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine; Biological: Infanrix™-IPV/Hib; Biological: Prevenar

Interventions

GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine BIOLOGICAL

Two doses; intramuscular administration

GSK2340272A Group 1; GSK2340272A Group 2

Infanrix™-IPV/Hib BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

GSK2340272A Group 1; GSK2340272A Group 2

Prevenar BIOLOGICAL

Routine infant immunisation vaccine, three doses administered intramuscularly

GSK2340272A Group 1; GSK2340272A Group 2

Eligibility Criteria

• Age: 8 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Bergen, 5021, Norway

Location

GSK Investigational Site

Hønefoss, N-3515, Norway

Location

GSK Investigational Site

Lierskogen, 3420, Norway

Location

GSK Investigational Site

Oslo, 0027, Norway

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: November 17, 2009
• Primary Completion: November 25, 2010
• Study Completion: November 25, 2010
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

NO (4)