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

NCT ID: NCT01453998

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 657 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-14
• Study Completion Date: 2012-11-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GSK217744 Group 1

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.

Group Type: EXPERIMENTAL

Infanrix hexa

Intervention Type: BIOLOGICAL

Single dose, licensed formulation, intramuscular into right thigh

Prevenar 13

Intervention Type: BIOLOGICAL

Single co-administered dose, intramuscular into left thigh

GSK217744

Intervention Type: BIOLOGICAL

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

GSK217744 Group 2

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.

Group Type: EXPERIMENTAL

Infanrix hexa

Intervention Type: BIOLOGICAL

Single dose, licensed formulation, intramuscular into right thigh

Prevenar 13

Intervention Type: BIOLOGICAL

Single co-administered dose, intramuscular into left thigh

GSK217744

Intervention Type: BIOLOGICAL

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

Infanrix hexa Group

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.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa

Intervention Type: BIOLOGICAL

Single dose, licensed formulation, intramuscular into right thigh

Prevenar 13

Intervention Type: BIOLOGICAL

Single co-administered dose, intramuscular into left thigh

Interventions

Infanrix hexa

Single dose, licensed formulation, intramuscular into right thigh

Intervention Type: BIOLOGICAL

Prevenar 13

Single co-administered dose, intramuscular into left thigh

Intervention Type: BIOLOGICAL

GSK217744

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

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV/Hib; Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Collapse or shock-like state (hypotonic-hyporesponsive episode) 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° on rectal setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 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

Santo Domingo, , Dominican Republic

GSK Investigational Site

Santo Domingo, Distrito Nacional, , Dominican Republic

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Kuopio, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Vantaa, , Finland

Countries

Dominican Republic; Finland

References

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.

Reference Type: DERIVED

PMID: 28340322 (View on PubMed)

Other Identifiers

2011-000876-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114843

Identifier Type: -

Identifier Source: org_study_id