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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-07

Study Completion Date

2007-10-17

Brief Summary

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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).

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Detailed Description

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

Conditions

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Infections, Streptococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Synflorix 1 Group

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.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

3 Intramuscular injections.

Tritanrix-HepB

Intervention Type BIOLOGICAL

3 Intramuscular injections

Hiberix

Intervention Type BIOLOGICAL

Reconstituted with Tritanrix before injection

Polio Sabin.

Intervention Type BIOLOGICAL

3 oral doses.

Poliorix.

Intervention Type BIOLOGICAL

3 intramuscular injections

Synflorix 2 Group

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.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

3 Intramuscular injections.

Tritanrix-HepB

Intervention Type BIOLOGICAL

3 Intramuscular injections

Hiberix

Intervention Type BIOLOGICAL

Reconstituted with Tritanrix before injection

Polio Sabin.

Intervention Type BIOLOGICAL

3 oral doses.

Poliorix.

Intervention Type BIOLOGICAL

3 intramuscular injections

Prevenar 1 Group

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.

Group Type ACTIVE_COMPARATOR

Prevenar

Intervention Type BIOLOGICAL

3 Intramuscular injections

Tritanrix-HepB

Intervention Type BIOLOGICAL

3 Intramuscular injections

Hiberix

Intervention Type BIOLOGICAL

Reconstituted with Tritanrix before injection

Polio Sabin.

Intervention Type BIOLOGICAL

3 oral doses.

Poliorix.

Intervention Type BIOLOGICAL

3 intramuscular injections

Prevenar 2 Group

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.

Group Type ACTIVE_COMPARATOR

Prevenar

Intervention Type BIOLOGICAL

3 Intramuscular injections

Tritanrix-HepB

Intervention Type BIOLOGICAL

3 Intramuscular injections

Hiberix

Intervention Type BIOLOGICAL

Reconstituted with Tritanrix before injection

Polio Sabin.

Intervention Type BIOLOGICAL

3 oral doses.

Poliorix.

Intervention Type BIOLOGICAL

3 intramuscular injections

Interventions

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Pneumococcal conjugate vaccine GSK1024850A

3 Intramuscular injections.

Intervention Type BIOLOGICAL

Prevenar

3 Intramuscular injections

Intervention Type BIOLOGICAL

Tritanrix-HepB

3 Intramuscular injections

Intervention Type BIOLOGICAL

Hiberix

Reconstituted with Tritanrix before injection

Intervention Type BIOLOGICAL

Polio Sabin.

3 oral doses.

Intervention Type BIOLOGICAL

Poliorix.

3 intramuscular injections

Intervention Type BIOLOGICAL

Other Intervention Names

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DTPw-HBV Hib OPV IPV

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

City of Muntinlupa, , Philippines

Site Status

GSK Investigational Site

Gdansk, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Trzebnica, , Poland

Site Status

GSK Investigational Site

Tuchola, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

Countries

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Philippines Poland

References

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Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.

Reference Type DERIVED

PMID: 19325452 (View on PubMed)

Bermal N, Szenborn L, Chrobot A, Alberto E, Lommel P, Gatchalian S, Dieussaert I, Schuerman L. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S89-96. doi: 10.1097/INF.0b013e318199f901.

Reference Type DERIVED

PMID: 19325451 (View on PubMed)

Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.

Reference Type DERIVED

PMID: 19325447 (View on PubMed)

Study Documents

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