Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

NCT01453998 | Completed Phase 2 Results

• 2 other identifiers: 1148432011-000876-33
• Study Type: interventional
• Target: 657
• Locations: 2 countries
• Sites: 16

Brief Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

  A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies

  A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

• Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens

  A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

  1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Number of Seroprotected Subjects Against Anti-HBs Antigens

  A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).

  1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

• Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3

  A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

  1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3

  A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.

  1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

• Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

  A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

  1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Number of Seroprotected Subjects for Anti-PRP

  A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

  1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

• Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

  Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

  1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Concentrations for Anti-PT, Anti-FHA and Anti-PRN

  Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.

  1 month post booster vaccination (subjects enrolled after protocol amendment 2)

Secondary Outcomes (42)

• Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

  Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)

• Concentrations for Anti-D and Anti-T Antibodies

  Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

  Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

• Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies

  Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)

• Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)

  Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)

Study Arms (3)

GSK217744 Group 1

EXPERIMENTAL

Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

Biological: Infanrix hexa; Biological: Prevenar 13; Biological: GSK217744

GSK217744 Group 2

EXPERIMENTAL

Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

Biological: Infanrix hexa; Biological: Prevenar 13; Biological: GSK217744

Infanrix hexa Group

ACTIVE COMPARATOR

Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.

Biological: Infanrix hexa; Biological: Prevenar 13

Interventions

Infanrix hexa BIOLOGICAL

Single dose, licensed formulation, intramuscular into right thigh

Also known as: DTPa-HBV-IPV/Hib

GSK217744 Group 1; GSK217744 Group 2; Infanrix hexa Group

Prevenar 13 BIOLOGICAL

Single co-administered dose, intramuscular into left thigh

Also known as: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

GSK217744 Group 1; GSK217744 Group 2; Infanrix hexa Group

GSK217744 BIOLOGICAL

Single dose, investigational formulation A or B, intramuscular into right thigh

GSK217744 Group 1; GSK217744 Group 2

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.
• A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.
• Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
• Written informed consent obtained from the parent(s)/LAR(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 (drug or vaccine) other than the study vaccines within 30 days preceding the booster 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 dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
• Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884).
• Serious chronic illness.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.
• Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing.
• Anaphylactic or other hypersensitivity reaction.
• Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
• Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

GSK Investigational Site

Santo Domingo, Distrito Nacional, Dominican Republic

Location

GSK Investigational Site

Espoo, 02100, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Kuopio, 70210, Finland

Location

GSK Investigational Site

Lahti, 15140, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

GSK Investigational Site

Vantaa, 01600, Finland

Location

Related Publications (1)

• Vesikari T, Rivera L, Korhonen T, Ahonen A, Cheuvart B, Hezareh M, Janssens W, Mesaros N. Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa. Hum Vaccin Immunother. 2017 Jul 3;13(7):1505-1515. doi: 10.1080/21645515.2017.1294294. Epub 2017 Mar 24.

  PMID: 28340322 DERIVED

MeSH Terms

Conditions

Hepatitis B; Haemophilus Infections; Tetanus; Diphtheria; Poliomyelitis

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 18, 2011
• Study Start: October 14, 2011
• Primary Completion: November 12, 2012
• Study Completion: November 12, 2012
• Last Updated: July 17, 2020
• Results First Posted: July 28, 2014

Record last verified: 2020-07

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

FI (14); DO (2)