Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

Treatments: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Hiberix; Biological: Polio Sabin.; Biological: Prevenar; Biological: Tritanrix-HepB; Biological: Poliorix.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344318

107007

Details and patient eligibility

About

This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.

The study has 2 groups.

• One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
• The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.

All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).

Full description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Enrollment: 806 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Born after a gestation period between 36 and 42 weeks.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
• History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
• Acute disease at the time of enrolment
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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806 participants in 4 patient groups

Synflorix 1 Group

Experimental group

Description:

Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age.

Treatment:

Biological: Poliorix.

Biological: Tritanrix-HepB

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: Polio Sabin.

Biological: Hiberix

Synflorix 2 Group

Experimental group

Description:

Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age.

Treatment:

Biological: Poliorix.

Biological: Tritanrix-HepB

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: Polio Sabin.

Biological: Hiberix

Prevenar 1 Group

Active Comparator group

Description:

Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age.

Treatment:

Biological: Poliorix.

Biological: Prevenar

Biological: Tritanrix-HepB

Biological: Polio Sabin.

Biological: Hiberix

Prevenar 2 Group

Active Comparator group

Description:

Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age.

Treatment:

Biological: Poliorix.

Biological: Prevenar

Biological: Tritanrix-HepB

Biological: Polio Sabin.

Biological: Hiberix