Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Streptococcal

Treatments: Biological: Prevenar 13; Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1); Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2); Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib); Biological: Synflorix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204658

2010-019730-27 (EudraCT Number)

113994

Details and patient eligibility

About

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Full description

This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A [high dose (HD) or low dose (LD)] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.

Enrollment: 576 patients

Sex: All

Ages: 6 to 14 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
• Written informed consent obtained from the parents/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) 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.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
• 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.
• Previous vaccination against S. pneumoniae since birth.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature >= 38.0°C on rectal setting or >= 37.5°C on oral or axillary setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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576 participants in 4 patient groups

10PP-LD/Infanrix hexa Group

Experimental group

Description:

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

Treatment:

Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)

Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)

10PP-HD/Infanrix hexa Group

Experimental group

Description:

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

Treatment:

Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)

Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Synflorix/Infanrix hexa Group

Active Comparator group

Description:

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.

Treatment:

Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)

Biological: Synflorix

Prevnar 13/Infanrix hexa Group

Active Comparator group

Description:

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.

Treatment:

Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)

Biological: Prevenar 13