Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-04

Study Completion Date

2013-10-05

Brief Summary

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The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions.

This study will also explore vaccine impact on occurrence of respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.

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Detailed Description

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The protocol posting has been updated with regards to the enrolment of subjects and outcome measures following Protocol amendment 2, 22 August 2011.

Conditions

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Infections, Streptococcal Streptococcus Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10Pn3+1-6W- 6M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

10Pn2+1-6W-6M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Ctrl-6W-6M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.

Group Type ACTIVE_COMPARATOR

GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)

Intervention Type BIOLOGICAL

3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.

Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination.

10Pn7-11M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Ctrl7-11M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.

Group Type ACTIVE_COMPARATOR

GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)

Intervention Type BIOLOGICAL

3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.

Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination.

10Pn12-18M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Ctrl12-18M/043 Group

Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.

Group Type ACTIVE_COMPARATOR

GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)

Intervention Type BIOLOGICAL

2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children \>= 12 months of age at the time of first study vaccination.

Interventions

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Pneumococcal conjugate vaccine GSK1024850A

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Intervention Type BIOLOGICAL

GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)

3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.

Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination.

Intervention Type BIOLOGICAL

GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)

2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children \>= 12 months of age at the time of first study vaccination.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
* Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria

* Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine other than the study vaccine, or planned use during the study period. If a child belongs to a high risk group for pneumococcal infections for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
* Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
* Known severe hypersensitivity to any component of the study vaccines, including neomycin.
* Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes