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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-04

Study Completion Date

2014-05-07

Brief Summary

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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.

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Detailed Description

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

Conditions

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Infections, Streptococcal Streptococcus Pneumoniae Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Synflorix Group

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.

Group Type ACTIVE_COMPARATOR

Synflorix (3-Dose)

Intervention Type BIOLOGICAL

3 doses administered intramuscularly

Prevnar 1 Group

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.

Group Type EXPERIMENTAL

Synflorix (2-Dose)

Intervention Type BIOLOGICAL

2 doses administered intramuscularly

Prevenar 13 (Single Dose)

Intervention Type BIOLOGICAL

1 dose administered intramuscularly

Prevnar 2 Group

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.

Group Type EXPERIMENTAL

Synflorix (Single Dose)

Intervention Type BIOLOGICAL

1 dose administered intramuscularly

Prevenar 13 (2-Dose)

Intervention Type BIOLOGICAL

2 doses administered intramuscularly

Interventions

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Synflorix (3-Dose)

3 doses administered intramuscularly

Intervention Type BIOLOGICAL

Synflorix (2-Dose)

2 doses administered intramuscularly

Intervention Type BIOLOGICAL

Synflorix (Single Dose)

1 dose administered intramuscularly

Intervention Type BIOLOGICAL

Prevenar 13 (Single Dose)

1 dose administered intramuscularly

Intervention Type BIOLOGICAL

Prevenar 13 (2-Dose)

2 doses administered intramuscularly

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes