Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Streptococcus Pneumoniae Vaccines; Infections, Streptococcal

Treatments: Biological: Prevenar 13 (2-Dose); Biological: Prevenar 13 (Single Dose); Biological: Synflorix (3-Dose); Biological: Synflorix (Single Dose); Biological: Synflorix (2-Dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01641133

2013-003479-36 (EudraCT Number)

115992

Details and patient eligibility

About

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Full description

This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

Enrollment: 457 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
• A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of at least 36 weeks.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.

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 vaccines, or planned use during the entire study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use 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.
• 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 study vaccine.
• Major congenital defects or serious chronic illness.
• History of any seizures or progressive neurological disease.
• Administration of immunoglobulins and/or blood products since birth or planned use during the study.
• Acute disease and/or fever at the time of enrolment.
• Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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457 participants in 3 patient groups

Synflorix Group

Active Comparator group

Description:

Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

Treatment:

Biological: Synflorix (3-Dose)

Prevnar 1 Group

Experimental group

Description:

Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.

Treatment:

Biological: Prevenar 13 (Single Dose)

Biological: Synflorix (2-Dose)

Prevnar 2 Group

Experimental group

Description:

Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.

Treatment:

Biological: Synflorix (Single Dose)

Biological: Prevenar 13 (2-Dose)