Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

NCT00971321 | Completed Phase 2 Results

• 1 other identifier: 113462
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 5

Brief Summary

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months. This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2340272A

Outcome Measures

Primary Outcomes (7)

• Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

  Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 0

• Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

  Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 42

• Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies

  Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 0

• Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies

  Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 42

• Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies

  Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 42

• Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

  Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 42

• Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers

  Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

  At Day 42

Secondary Outcomes (16)

• Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

  At Days 0, 21, 42, and at Month 11-12

• Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies

  At Days 0, 21, 42 and at Month 11-12

• Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers

  At Days 21, 42 and at Month 11-12

• Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

  At Days 0, 21, 42 and at Month 11-12

• Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers

  At Days 21, 42 and at Month 11-12

Study Arms (2)

GSK 2340272A F1 Group

EXPERIMENTAL

Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.

Biological: Pandemic influenza vaccine GSK2340272A

GSK 2340272A F2 Group

EXPERIMENTAL

Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.

Biological: Pandemic influenza vaccine GSK2340272A

Interventions

Pandemic influenza vaccine GSK2340272A BIOLOGICAL

Two primary intramuscular (IM) injections

GSK 2340272A F1 Group; GSK 2340272A F2 Group

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
• Written informed consent obtained from the parent(s) or 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.

You may not qualify if:

• 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.
• Clinically or virologically confirmed influenza infection within six months preceding the study start.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• 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.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment
• 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 condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
• Child in Care.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

Related Publications (2)

• Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.

  PMID: 26176592 DERIVED

• Carmona A, Omenaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Aristegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. doi: 10.1016/j.vaccine.2010.06.065. Epub 2010 Jun 29.

  PMID: 20600478 DERIVED

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

Condition Hierarchy (Ancestors)

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

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: August 27, 2009
• First Posted: September 3, 2009
• Study Start: September 10, 2009
• Primary Completion: November 24, 2010
• Study Completion: November 24, 2010
• Last Updated: February 25, 2019
• Results First Posted: February 25, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

ES (5)