Back to resultsPrimary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pneumococcal vaccine GSK1024850A (Synflorix)
Prevenar
GSK Biologicals' Hiberix™
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Streptococcal focused on measuring Streptococcus pneumoniae, pneumococcal conjugate vaccine
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
- History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synflorix Group
Prevenar Group
Arm Description
Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Outcomes
Primary Outcome Measures
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Secondary Outcome Measures
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.
Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL.
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the 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 and 23F.
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
Pneumococcal cross-reactive serotypes were 6A and 19A.
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Anti-PD Antibody Concentration
Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
Concentration of anti-PRP antibody given as GMC in ug/mL.
Number of Subjects With Seroprotection Status Against PRP
Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as axillary temperature >= 37.5 degrees Celsius.
Number of Subjects Reporting Unsolicited Adverse Events
Number of Subjects With 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00680914
Brief Title
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Official Title
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 10, 2008 (Actual)
Primary Completion Date
May 8, 2009 (Actual)
Study Completion Date
May 8, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are:
To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life.
To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.
Detailed Description
Vaccination course at 2, 4, 6 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Streptococcus pneumoniae, pneumococcal conjugate vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
503 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synflorix Group
Arm Type
Experimental
Arm Description
Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Arm Title
Prevenar Group
Arm Type
Active Comparator
Arm Description
Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine GSK1024850A (Synflorix)
Intervention Description
3 doses administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
Prevenar
Intervention Description
3 doses administered intramuscularly.
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' Hiberix™
Other Intervention Name(s)
Hib
Intervention Description
3 doses administered intramuscularly.
Primary Outcome Measure Information:
Title
Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
Description
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time Frame
One month after administration of 3rd dose of the pneumococcal conjugate vaccine
Secondary Outcome Measure Information:
Title
Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
Description
Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.
Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
Description
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the 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 and 23F.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
Description
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).
Pneumococcal cross-reactive serotypes were 6A and 19A.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
Description
Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Anti-PD Antibody Concentration
Description
Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
Time Frame
One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Description
Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
Description
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
Description
Concentration of anti-PRP antibody given as GMC in ug/mL.
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Number of Subjects With Seroprotection Status Against PRP
Description
Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL
Time Frame
One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Title
Number of Subjects Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed include pain, redness and swelling.
Time Frame
Within 4 days after each vaccination
Title
Number of Subjects With Solicited General Symptoms
Description
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.
Fever was defined as axillary temperature >= 37.5 degrees Celsius.
Time Frame
Within 4 days after each vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events
Time Frame
Within 31 days after each vaccination
Title
Number of Subjects With Serious Adverse Events (SAE)
Description
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.
Time Frame
Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
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 (pharmaceutical product or device).
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ansan
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Bucheon-si,
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
301-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeongnam
ZIP/Postal Code
641-560
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Iksan
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeju
ZIP/Postal Code
690-716
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju Jeonbuk
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon City
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Wonju-si Kangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
21817957
Citation
Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
Results Reference
background
Citation
Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
Results Reference
background
Citation
Kim CH et al. Immunogenicity of a 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and co-administered vaccines following primary vaccination in Asian infants. Abstract presented at the 5th Asian Congress of Pediatric Infectious Diseases (ACPID). Taipei, Taiwan, 23-26 September 2010.
Results Reference
background
Citation
Kim JS et al. Safety and reactogenicity of primary vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Citation
Kim KH et al. Immunogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
PubMed Identifier
21994351
Citation
Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.
Results Reference
background
Citation
Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Citation
Schuerman L et al. OPA assay is more reliable predictor of vaccine effectiveness against invasive pneumococcal disease (IPD) than ELISA antibody measurements. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Citation
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Citation
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110808
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
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