Primary Vaccination Course in Children Receiving Pneumoco... | NCT00680914

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synflorix Group	Experimental	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.	Biological: Pneumococcal vaccine GSK1024850A (Synflorix) Biological: GSK Biologicals' Hiberix™
Prevenar Group	Active Comparator	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.	Biological: Prevenar Biological: GSK Biologicals' Hiberix™

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal vaccine GSK1024850A (Synflorix)	Biological	3 doses administered intramuscularly.	Synflorix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	One month after administration of 3rd dose of the pneumococcal conjugate vaccine

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ansan		425-707	South Korea
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation
21817957	Background	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.
	Background	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.
	Background	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.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
110808	Study Protocol	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
FG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

One month after administration of 3rd dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000344 OG001123

Title

Denominators

Categories

Anti-1

Title	Measurements
	OG000344 OG0017

Anti-4

Title	Measurements
	OG000

Secondary

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.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.

Posted

Number

subjects

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants

Secondary

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.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Number

subjects

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants

Secondary

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.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Number

subjects

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

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.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

Anti-PD Antibody Concentration

Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes

Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Number

subjects

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants

Secondary

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

Concentration of anti-PRP antibody given as GMC in ug/mL.

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Geometric Mean

95% Confidence Interval

ug/mL

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

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

Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Posted

Number

subjects

One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Posted

Number

subjects

Within 4 days after each vaccination

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

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.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Posted

Number

subjects

Within 4 days after each vaccination

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Unsolicited Adverse Events

Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Posted

Number

subjects

Within 31 days after each vaccination

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants	OG000

Secondary

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.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Posted

Number

subjects

Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5

ID	Title	Description
OG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
OG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bronchiolitis	Infections and infestations	Non-systematic Assessment	EG00022 affected374 at risk EG0011 affected129 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0008 affected374 at risk EG0013 affected129 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0009 affected374 at risk EG0011 affected129 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0004 affected374 at risk EG0011 affected129 at risk
Croup infections	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0011 affected129 at risk
Intussusception	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected374 at risk EG0011 affected129 at risk
Meningitis aseptic	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0011 affected129 at risk
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0003 affected374 at risk EG0010 affected129 at risk
Bronchopneumonia	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
enteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected374 at risk EG0011 affected129 at risk
Gastroenteritis rotavirus	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
Hydronephrosis	Renal and urinary disorders	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
Otitis media acute	Infections and infestations	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0002 affected374 at risk EG0010 affected129 at risk
Anorexia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected374 at risk EG0011 affected129 at risk
Cystitis	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Exanthema subitum	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Febrile convulsion	Nervous system disorders	Non-systematic Assessment	EG0000 affected374 at risk EG0011 affected129 at risk
Hepatitis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Herpangina	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Injection site abscess	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Laryngitis	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0011 affected129 at risk
Meningitis	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Otitis media	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Pyelonephritis acute	Infections and infestations	Non-systematic Assessment	EG0001 affected374 at risk EG0010 affected129 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	Non-systematic Assessment	EG0000 affected374 at risk EG0011 affected129 at risk
rhinitis	Infections and infestations	Non-systematic Assessment	EG0000 affected374 at risk EG0011 affected129 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected374 at risk EG0011 affected129 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pain	General disorders	Systematic Assessment	EG000210 affected374 at risk EG00172 affected129 at risk
Redness	General disorders	Systematic Assessment	EG000252 affected374 at risk EG00184 affected129 at risk
Swelling	General disorders	Systematic Assessment	EG000182 affected374 at risk EG00169 affected129 at risk
Drowsiness	General disorders	Systematic Assessment	EG000212 affected374 at risk EG00165 affected129 at risk
Fever	General disorders	Systematic Assessment	EG000113 affected374 at risk EG00133 affected129 at risk
Irritability	General disorders	Systematic Assessment	EG000293 affected374 at risk EG00199 affected129 at risk
Loss of appetite	General disorders	Systematic Assessment	EG000177 affected374 at risk EG00166 affected129 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00044 affected374 at risk EG00116 affected129 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00042 affected374 at risk EG00116 affected129 at risk
bronchiolitis	Infections and infestations	Non-systematic Assessment	EG00020 affected374 at risk EG0014 affected129 at risk
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG00023 affected374 at risk EG0016 affected129 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG00014 affected374 at risk EG0017 affected129 at risk

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
C547294	PHiD-CV vaccine
D000069443	Heptavalent Pneumococcal Conjugate Vaccine

ID	Term
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D017778	Vaccines, Combined

ID	Title	Description
BG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
BG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Synflorix Group	Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4			56	374	357	374
EG001	Prevenar Group	Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4			9	129	124	129