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

NCT ID: NCT01248884

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 721 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-09
• Study Completion Date: 2012-01-05

Brief Summary

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

Detailed Description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GSK217744 Group 1

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Group Type: EXPERIMENTAL

Prevenar 13®

Intervention Type: BIOLOGICAL

3 co-administered doses, intramuscular into right thigh

GSK217744

Intervention Type: BIOLOGICAL

3 doses, intramuscular into left thigh

GSK217744 Group 2

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Group Type: EXPERIMENTAL

Prevenar 13®

Intervention Type: BIOLOGICAL

3 co-administered doses, intramuscular into right thigh

GSK217744

Intervention Type: BIOLOGICAL

3 doses, intramuscular into left thigh

Infanrix hexa Group

Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Group Type: ACTIVE_COMPARATOR

Infanrix hexa™

Intervention Type: BIOLOGICAL

3 doses, intramuscular into left thigh

Prevenar 13®

Intervention Type: BIOLOGICAL

3 co-administered doses, intramuscular into right thigh

Interventions

Infanrix hexa™

3 doses, intramuscular into left thigh

Intervention Type: BIOLOGICAL

Prevenar 13®

3 co-administered doses, intramuscular into right thigh

Intervention Type: BIOLOGICAL

GSK217744

3 doses, intramuscular into left thigh

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
• Born after a gestation period of 37 to 42 weeks inclusive.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• 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 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 a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
• 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, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 90 Days
• 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

113948

Identifier Type: -

Identifier Source: org_study_id