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

NCT00871741 | Terminated Phase 2 Results

• 1 other identifier: 111761
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Tetanus; Poliomyelitis; Neisseria Meningitidis; Haemophilus Influenzae Type b; Diphtheria; Acellular Pertussis; Hepatitis B

Keywords

Combined vaccine; Primary vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms

  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

  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)

  During the 31-day (Days 0-30) post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period (from Month 0 to Month 9)

Study Arms (2)

GSK2202083A GROUP

EXPERIMENTAL

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

INFANRIX + MENJUGATE GROUP

ACTIVE COMPARATOR

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; Biological: Menjugate

Interventions

GSK2202083A vaccine BIOLOGICAL

Intramuscular, three doses

GSK2202083A GROUP

Infanrix hexa BIOLOGICAL

Intramuscular, three doses

INFANRIX + MENJUGATE GROUP

Menjugate BIOLOGICAL

Intramuscular, two doses

INFANRIX + MENJUGATE GROUP

Eligibility Criteria

• Age: 8 Weeks - 16 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Bratislava, 841 08, Slovakia

Location

GSK Investigational Site

Bratislava, 851 05, Slovakia

Location

GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

Location

GSK Investigational Site

Dunajská Streda, 929 01, Slovakia

Location

GSK Investigational Site

Nové Zámky, 940 01, Slovakia

Location

GSK Investigational Site

Ružomberok, 034 01, Slovakia

Location

GSK Investigational Site

Štúrovo, 943 01, Slovakia

Location

GSK Investigational Site

Trnava, 917 01, Slovakia

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

Tetanus; Poliomyelitis; Haemophilus Infections; Diphtheria; Hepatitis B

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System 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: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: June 25, 2009
• Study Completion: June 25, 2009
• Last Updated: June 6, 2018
• Results First Posted: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

SL (8)