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

NCT ID: NCT01171989

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-18
• Study Completion Date: 2010-12-03

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK2202083A + SYNFLORIX GROUP

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.

Group Type: EXPERIMENTAL

GSK2202083A vaccine

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

Synflorix™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

INFANRIX HEXA/MENJUGATE GROUP

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.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

Menjugate™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP

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.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

NeisVac-C™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

Synflorix™

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

Interventions

GSK2202083A vaccine

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

Infanrix hexa™

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

Menjugate™

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

NeisVac-C™

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

Synflorix™

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Torun, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Wroclaw, , Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 23838777 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

2010-019253-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113978

Identifier Type: -

Identifier Source: org_study_id