Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.

Study Overview

• Status: Terminated
• Conditions: Hepatitis B; Tetanus; Diphtheria; Acellular Pertussis; Poliomyelitis; Neisseria Meningitidis; Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: GSK2202083A vaccine; Biological: Infanrix hexa; Biological: Menjugate

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 841 08
    • GSK Investigational Site
  • Bratislava, Slovakia, 851 05
    • GSK Investigational Site
  • Dolny Kubin, Slovakia, 026 01
    • GSK Investigational Site
  • Dunajska Streda, Slovakia, 929 01
    • GSK Investigational Site
  • Nove Zamky, Slovakia, 940 01
    • GSK Investigational Site
  • Ruzomberok, Slovakia, 034 01
    • GSK Investigational Site
  • Sturovo, Slovakia, 943 01
    • GSK Investigational Site
  • Trnava, Slovakia, 917 01
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
• 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
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK2202083A GROUP; Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.	Biological: GSK2202083A vaccine; Intramuscular, three doses
Active Comparator: INFANRIX + MENJUGATE GROUP; Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.	Biological: Infanrix hexa; Intramuscular, three doses; Biological: Menjugate; Intramuscular, two doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL	As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.	At Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms	The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. Subjects from Control Group did not receive the second study vaccination dose due to study termination.	During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = any general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination. Subjects from Control Group did not receive the second study vaccination dose due to study termination.	During the 8-day (Days 0-7) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events AE(s)	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.	During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (from Month 0 to Month 9)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 25, 2009
• Study Completion (Actual): June 25, 2009

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Primary vaccination; Combined vaccine
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Corynebacterium Infections; Hepatitis; Myelitis; Hepatitis B; Diphtheria; Poliomyelitis
• Other Study ID Numbers: 111761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 111761
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register