Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).

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

Official Title
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Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

Conditions
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Hepatitis B, Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria, Streptococcus Pneumoniae Vaccines

Intervention / Treatment
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* Biological: Pneumococcal conjugate vaccine GSK1024850A
* Biological: Prevenar
* Biological: Infanrix hexa
* Biological: Infanrix IPV Hib
* Biological: Infanrix penta
* Biological: Infanrix IPV
* Biological: Meningitec
* Biological: NeisVac-C
* Biological: Menitorix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. A male or female between, and including, 11-18 months of age at the time of the booster vaccination. A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine. 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. Exclusion Criteria: Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines). Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005. History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease. 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 progressive neurological disease. Acute disease at the time of enrolment. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. Administration of immunoglobulins and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™<br>Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age. | Biological: Pneumococcal conjugate vaccine GSK1024850A<br>* Intramuscular injection, 1 dose.<br>Biological: Infanrix hexa<br>* Intramuscular injection, 1 dose. In Germany and Poland.<br>* Other names: DTPa-HBV-IPV/Hib (GSK Biologicals).;Biological: Infanrix IPV Hib<br>* Intramuscular injection, 1 dose. In Spain.<br>* Other names: DTPa-IPV/Hib (GSK Biologicals).;Biological: Meningitec<br>* Intramuscular injection, 1 dose.<br>* Other names: Meningococcal C conjugate vaccine (Wyeth).;|
| Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™<br>Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age. | Biological: Pneumococcal conjugate vaccine GSK1024850A<br>* Intramuscular injection, 1 dose.<br>Biological: Infanrix hexa<br>* Intramuscular injection, 1 dose. In Germany and Poland.<br>* Other names: DTPa-HBV-IPV/Hib (GSK Biologicals).;Biological: Infanrix IPV Hib<br>* Intramuscular injection, 1 dose. In Spain.<br>* Other names: DTPa-IPV/Hib (GSK Biologicals).;Biological: NeisVac-C<br>* Intramuscular injection, 1 dose.<br>* Other names: Meningococcal C conjugate vaccine (Baxter).;|
| Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™<br>Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. | Biological: Pneumococcal conjugate vaccine GSK1024850A<br>* Intramuscular injection, 1 dose.<br>Biological: Infanrix penta<br>* Intramuscular injection, 1 dose. In Germany and Poland.<br>* Other names: DTPa-HBV-IPV (GSK Biologicals).;Biological: Infanrix IPV<br>* Intramuscular injection, 1 dose. In Spain.<br>* Other names: DTPa-IPV (GSK Biologicals);Biological: Menitorix<br>* Intramuscular injection, 1 dose.<br>* Other names: Combined Hib-MenC vaccine (GSK Biologicals).;|
| Active Comparator: Prevenar™ + Menitorix™<br>Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. | Biological: Prevenar<br>* Intramuscular injection, 1 dose.<br>* Other names: Pneumococcal conjugate vaccine (Wyeth Lederle).;Biological: Infanrix penta<br>* Intramuscular injection, 1 dose. In Germany and Poland.<br>* Other names: DTPa-HBV-IPV (GSK Biologicals).;Biological: Infanrix IPV<br>* Intramuscular injection, 1 dose. In Spain.<br>* Other names: DTPa-IPV (GSK Biologicals);Biological: Menitorix<br>* Intramuscular injection, 1 dose.<br>* Other names: Combined Hib-MenC vaccine (GSK Biologicals).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) | Fever was measured as rectal temperature. | During the 4-day (Day 0-3) period after the booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | During the 4-day (Day 0-3) period after the booster vaccination | 
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite. | During the 4-day (Day 0-3) period after the booster vaccination | 
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | During the 31-day (Day 0-30) period after the booster vaccination | 
| Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | During the 31-day (Day 0-30) period after the booster vaccination | 
| Number of Subjects Reporting Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | From the beginning of the study up to the end of the extended 6-month safety follow-up period | 
| Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value | Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value | Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value | Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value | Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value | Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value | Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL. | Before (pre) and one month after (post) the booster administration | 
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value | Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL. | Before (pre) and one month after (post) the booster administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fever., Meningococcal disease., Pneumococcal disease., Meningococcal vaccine., Pneumococcal vaccine., Immunogenicity., Booster vaccination., Safety.