Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose

NCT01171989 | Completed Phase 2 Results

• 2 other identifiers: 1139782010-019253-18
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 9

Brief Summary

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).

Conditions

Tetanus; Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis; Acellular Pertussis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni

Keywords

booster vaccination; combined vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)

  A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).

  At Month 1, post-booster dose

• Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)

  A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.

  At Month 1, post-booster dose

Secondary Outcomes (20)

• Number of Seropositive Subjects for Anti-PRP

  At Month 0, before the booster dose

• Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off

  At Month 0 and Month 1, before and one month after booster dose

• Anti-PRP Antibody Concentrations

  At Month 0 and Month 1, before and one month after booster dose

• Number of Seroprotected Subjects Against rSBA-MenC

  At Month 0, before the booster dose

• Number of Seropositive Subjects for Anti-rSBA-MenC

  At Month 0 and Month 1, before and one month after booster dose

Study Arms (3)

GSK2202083A + SYNFLORIX GROUP

EXPERIMENTAL

Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

Biological: GSK2202083A vaccine; Biological: Synflorix™

INFANRIX HEXA/MENJUGATE GROUP

ACTIVE COMPARATOR

Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

Biological: Infanrix hexa™; Biological: Menjugate™

INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP

ACTIVE COMPARATOR

Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.

Biological: Infanrix hexa™; Biological: NeisVac-C™; Biological: Synflorix™

Interventions

GSK2202083A vaccine BIOLOGICAL

Intramuscular, one dose.

GSK2202083A + SYNFLORIX GROUP

Infanrix hexa™ BIOLOGICAL

Intramuscular, one dose.

INFANRIX HEXA/MENJUGATE GROUP; INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP

Menjugate™ BIOLOGICAL

Intramuscular, one dose.

INFANRIX HEXA/MENJUGATE GROUP

NeisVac-C™ BIOLOGICAL

Intramuscular, one dose.

INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP

Synflorix™ BIOLOGICAL

Intramuscular, one dose.

GSK2202083A + SYNFLORIX GROUP; INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
• Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
• A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
• Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
• Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
• Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
• Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• The following adverse event having occurred after previous administration of DTP vaccine:
• Encephalopathy.
• Temperature of \>= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
• Collapse or shock-like state within 48 hours of vaccination.
• Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting \>= 3 hours.
• Seizures with or without fever occurring within 3 days of vaccination.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, 31-422, Poland

Location

GSK Investigational Site

Krakow, 31-503, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Torun, Poland

Location

GSK Investigational Site

Trzebnica, 55-100, Poland

Location

GSK Investigational Site

Wroclaw, 50345, Poland

Location

Related Publications (1)

• Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.

  PMID: 23838777 BACKGROUND

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; Diphtheria; Haemophilus Infections; Hepatitis B; Poliomyelitis

Interventions

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

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 29, 2010
• Study Start: August 18, 2010
• Primary Completion: December 3, 2010
• Study Completion: December 3, 2010
• Last Updated: January 21, 2020
• Results First Posted: April 11, 2017

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

PL (9)