Vaccination With GSK 1024850A in Children Primed With GSK... | NCT00907777

NCT00907777

ID	Type	Description	Link
2008-007605-37	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pn Group	Experimental	Subjects receiving GSK 1024850A vaccine.	Biological: Pneumococcal conjugate vaccine GSK 1024850A
Prev Group	Active Comparator	Subjects receiving Prevenar™ vaccine.	Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal conjugate vaccine GSK 1024850A	Biological	One dose of vaccine will be injected intramuscularly into the deltoid.	Pn Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaccine Pneumococcal Serotype Antibody Concentrations	The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 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 additional dose

Secondary Outcomes

Measure	Description	Time Frame
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes	The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. 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 additional dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between, and including, 46-50 months of age at the time of vaccination.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
Written informed consent obtained from both parents/guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
Administration of any pneumococcal vaccine since the end of study NCT00333450.
Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
History of any neurologic disorders or seizures
Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
History of hypotonic-hyporesponsive episode after any previous vaccination.
Major congenital defects or serious chronic illness.
History of invasive pneumococcal diseases.
Acute disease at the time of vaccination
Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mannheim	Baden-Wurttemberg	68163	Germany
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21909049	Background	Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.

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
112807	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
BG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

ANTI-1 PRE

- ParticipantsOG00021
- ParticipantsOG00124

Title	Measurements
	OG0000.14(0.09 to 0.23)

Secondary

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before (PRE) and one month after (POST) the additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Cross-reactive Pneumococcal Serotype Antibody Concentrations

The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Before (PRE) and one month after (POST) the additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before (PRE) and one month after (POST) the additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Anti-protein D Antibody Concentrations

The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Before (PRE) and one month after (POST) the additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) post-additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.

Posted

Count of Participants

Participants

During the 8-day (Days 0-7) post-additional dose

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.

Posted

Count of Participants

Participants

Within 31 days (Day 0-30) post-additional vaccination

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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, or may evolve into one of the outcomes listed above.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.

Posted

Count of Participants

Participants

Throughout the entire study period (approximately 1 month per subject)

ID	Title	Description
OG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
OG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Prevnar Group	Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.	0	25	0	25	17	25
EG001	GSK 1024850A Group	Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.	0	27	0	27	20	27

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG00011 affected25 at risk EG00116 affected26 at risk
Redness	General disorders	MedDRA 12.1	Systematic Assessment	EG00013 affected25 at risk EG00114 affected26 at risk
Swelling	General disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected25 at risk EG0019 affected26 at risk
Drowsiness	General disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected25 at risk EG00112 affected26 at risk
Fever (>38.0°C)	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected25 at risk EG0018 affected26 at risk
Irritability	General disorders	MedDRA 12.1	Systematic Assessment	EG0005 affected25 at risk EG0019 affected26 at risk
Loss of appetite	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected25 at risk EG00112 affected26 at risk

ID	Term
D013290	Streptococcal Infections
D006192	Haemophilus Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections

OG0010.38(0.25 to 0.56)

Units	Counts
Participants	OG00024 OG00126

Units	Counts
Participants	OG00024 OG00126

Units	Counts
Participants	OG00024 OG00124

Units	Counts
Participants	OG00024 OG00126

Units	Counts
Participants	OG00025 OG00127