Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00907777
• Collaborator: (none)
• Enrollment: 52
• Locations: 17
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site: 3.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Condition or Disease	Intervention/Treatment	Phase
Infections, Streptococcal; Streptococcus Pneumoniae	Biological: Pneumococcal conjugate vaccine GSK 1024850A; Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine
• Actual Study Start Date: Jun 23, 2009
• Actual Primary Completion Date: Oct 5, 2009
• Actual Study Completion Date: Oct 5, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pn Group Subjects receiving GSK 1024850A vaccine.	Biological: Pneumococcal conjugate vaccine GSK 1024850A; One dose of vaccine will be injected intramuscularly into the deltoid.
Active Comparator: Prev Group Subjects receiving Prevenar™ vaccine.	Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's); One dose of vaccine will be injected intramuscularly into the deltoid.

Outcome Measures

Primary Outcome Measures

1. Vaccine Pneumococcal Serotype Antibody Concentrations [Before (PRE) and one month after (POST) the additional dose]

   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.

Secondary Outcome Measures

1. Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes [Before (PRE) and one month after (POST) the additional dose]

   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.

2. Cross-reactive Pneumococcal Serotype Antibody Concentrations [Before (PRE) and one month after (POST) the additional dose]

   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.

3. Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes [Before (PRE) and one month after (POST) the additional dose]

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

4. Anti-protein D Antibody Concentrations [Before (PRE) and one month after (POST) the additional dose]

   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).

5. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [During the 8-day (Days 0-7) post-additional dose]

   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.

6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 8-day (Days 0-7) post-additional dose]

   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.

7. Number of Subjects With Unsolicited Adverse Events (AEs) [Within 31 days (Day 0-30) post-additional vaccination]

   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.

8. Number of Subjects With Serious Adverse Events (SAEs) [Throughout the entire study period (approximately 1 month per subject)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 46 Months to 50 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Mannheim	Baden-Wuerttemberg	Germany	68163
2	GSK Investigational Site	Noerdlingen	Bayern	Germany	86720
3	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen	Germany	32549
4	GSK Investigational Site	Goch	Nordrhein-Westfalen	Germany	47574
5	GSK Investigational Site	Heiligenhaus	Nordrhein-Westfalen	Germany	42579
6	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen	Germany	41061
7	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen	Germany	41236
8	GSK Investigational Site	Willich	Nordrhein-Westfalen	Germany	47877
9	GSK Investigational Site	Frankenthal	Rheinland-Pfalz	Germany	67227
10	GSK Investigational Site	Mainz	Rheinland-Pfalz	Germany	55131
11	GSK Investigational Site	Leipzig	Sachsen	Germany	04178
12	GSK Investigational Site	Lobenstein	Thueringen	Germany	07356
13	GSK Investigational Site	Neuhaus am Rennweg	Thueringen	Germany	98724
14	GSK Investigational Site	Weimar	Thueringen	Germany	99425
15	GSK Investigational Site	Berlin		Germany	10315
16	GSK Investigational Site	Berlin		Germany	13055
17	GSK Investigational Site	Berlin		Germany	14197

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Köllges 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00907777
• Other Study ID Numbers: 112807; 2008-007605-37
• First Posted: May 25, 2009
• Last Update Posted: Nov 23, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Haemophilus influenzae; Streptococcus pneumoniae; safety; Pneumococcal conjugate vaccine; immunogenicity
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Pre-assignment Detail	During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	25	27
COMPLETED	25	26
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Prevnar Group	GSK 1024850A Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	25	27	52
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	46.6 (0.91)	46.7 (0.72)	46.65 (0.81)
Sex: Female, Male (Count of Participants)
Female	9 36%	17 63%	26 50%
Male	16 64%	10 37%	26 50%

Outcome Measures

1. Primary Outcome

Title	Vaccine Pneumococcal Serotype Antibody Concentrations
Description	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.
Time Frame	Before (PRE) and one month after (POST) the additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	24	26
ANTI-1 PRE	0.14	0.38
ANTI-1 POST	0.16	1.35
ANTI-4 PRE	0.27	0.12
ANTI-4 POST	4.3	6.76
ANTI-5 PRE	0.11	0.5
ANTI-5 POST	0.15	1.78
ANTI-6B PRE	0.65	0.48
ANTI-6B POST	7.46	1.68
ANTI-7F PRE	0.18	0.39
ANTI-7F POST	0.19	2.53
ANTI-9V PRE	0.48	0.44
ANTI-9V POST	6.88	2.13
ANTI-14 PRE	1.5	1.98
ANTI-14 POST	25.82	9.71
ANTI-18C PRE	0.34	0.48
ANTI-18C POST	4.23	6.4
ANTI-19F PRE	2.02	2.37
ANTI-19F POST	5.68	15.61
ANTI-23F PRE	0.33	0.23
ANTI-23F POST	5.82	1.27

2. Secondary Outcome

Title	Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Description	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.
Time Frame	Before (PRE) and one month after (POST) the additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	24	26
OPSONO-1 PRE	4	5.8
OPSONO-1 POST	5.5	49.3
OPSONO-4 PRE	20.7	12.3
OPSONO-4 POST	4814	4380.7
OPSONO-5 PRE	4.2	7.5
OPSONO-5 POST	4.4	50.6
OPSONO-6B PRE	188.2	66.3
OPSONO-6B POST	6734.3	1424.5
OPSONO-7F PRE	1202.9	1498.9
OPSONO-7F POST	1304.2	4657.1
OPSONO-9V PRE	612.9	442
OPSONO-9V POST	5829.4	2843.5
OPSONO-14 PRE	149.7	330
OPSONO-14 POST	5400.8	2812.4
OPSONO-18C PRE	16.1	23.7
OPSONO-18C POST	1615.2	2806.6
OPSONO-19F PRE	26.1	35.8
OPSONO-19F POST	241.6	837.3
OPSONO-23F PRE	1430.2	1383.2
OPSONO-23F POST	23977.2	4865.1

3. Secondary Outcome

Title	Cross-reactive Pneumococcal Serotype Antibody Concentrations
Description	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.
Time Frame	Before (PRE) and one month after (POST) the additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	24	26
ANTI-6A PRE	0.22	0.19
ANTI-6A POST	1.78	0.47
ANTI-19A PRE	0.39	0.29
ANTI-19A POST	0.8	1.24

4. Secondary Outcome

Title	Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Description	The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Time Frame	Before (PRE) and one month after (POST) the additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	24	24
OPSONO-6A PRE	106.9	117.7
OPSONO-6A POST	2320.4	966.2
OPSONO-19A PRE	10.4	19.6
OPSONO-19A POST	101.3	153.9

5. Secondary Outcome

Title	Anti-protein D Antibody Concentrations
Description	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).
Time Frame	Before (PRE) and one month after (POST) the additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	24	26
ANTI-PD PRE	104.1	173.1
ANTI-PD POST	85.9	1135.6

6. Secondary Outcome

Title	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description	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.
Time Frame	During the 8-day (Days 0-7) post-additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	25	26
Any Pain	11 44%	16 59.3%
Grade 3 Pain	0 0%	2 7.4%
Any Redness	13 52%	14 51.9%
Grade 3 Redness	7 28%	3 11.1%
Any Swelling	7 28%	9 33.3%
Grade 3 Swelling	4 16%	1 3.7%

7. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	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.
Time Frame	During the 8-day (Days 0-7) post-additional dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	25	26
Any Drowsiness	4 16%	12 44.4%
Grade 3 Drowsiness	0 0%	1 3.7%
Related Drowsiness	0 0%	8 29.6%
Any Fever	1 4%	8 29.6%
Grade 3 Fever	0 0%	0 0%
Related Fever	0 0%	6 22.2%
Any Irritability	5 20%	9 33.3%
Grade 3 Irritability	0 0%	1 3.7%
Related Irritability	2 8%	7 25.9%
Any Loss of appetite	3 12%	12 44.4%
Grade 3 Loss of appetite	0 0%	2 7.4%
Related Loss of appetite	1 4%	7 25.9%

8. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	Within 31 days (Day 0-30) post-additional vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	25	27
Count of Participants [Participants]	8 32%	6 22.2%

9. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
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, or may evolve into one of the outcomes listed above.
Time Frame	Throughout the entire study period (approximately 1 month per subject)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Prevnar Group	GSK 1024850A Group
Arm/Group Description	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.	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.
Measure Participants	25	27
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
Arm/Group Title	Prevnar Group		GSK 1024850A Group
Arm/Group Description	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.		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.
All Cause Mortality
	Prevnar Group		GSK 1024850A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/27 (0%)
Serious Adverse Events
	Prevnar Group		GSK 1024850A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Prevnar Group		GSK 1024850A Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/25 (68%)		20/27 (74.1%)
General disorders
Pain	11/25 (44%)		16/26 (61.5%)
Redness	13/25 (52%)		14/26 (53.8%)
Swelling	7/25 (28%)		9/26 (34.6%)
Drowsiness	4/25 (16%)		12/26 (46.2%)
Fever (>38.0°C)	1/25 (4%)		8/26 (30.8%)
Irritability	5/25 (20%)		9/26 (34.6%)
Loss of appetite	3/25 (12%)		12/26 (46.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.