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CompletedNCT00985751Updated Nov 5, 2020Results posted

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

A Phase 2 interventional study of Pneumococcal vaccine GSK2189242A (formulation 1) and Pneumococcal vaccine GSK2189242A (formulation 2) in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 10 sites in Czechia. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
257
Allocation
Randomized
Ages
12 Months to 23 Months
Sex
All
01

Study summary

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

02

Conditions studied

  • Infections, Streptococcal

Keywords

  • immunogenicity
  • toddlers
  • Pneumococcal vaccine
  • Haemophilus influenzae
  • safety
  • Streptococcus pneumoniae
  • Streptococcus Pneumoniae Vaccines
03

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 257 is close to the median of 250 across 105 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
  • Previous vaccination against S. pneumoniae since birth.
  • History of any hypersensitivity reaction following any previous vaccination.
  • Eczema and any history of allergy
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or any chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
  • Child in care.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
257 participants (actual)

Study arms

  • Experimental
    Group 1

    Biological: Pneumococcal vaccine GSK2189242A (formulation 1)

  • Experimental
    Group 2

    Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

  • Experimental
    Group 3

    Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

  • Experimental
    Group 4

    Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

  • Experimental
    Control Group

    Biological: Pneumococcal vaccine GSK1024850A

Interventions

  • BiologicalPneumococcal vaccine GSK2189242A (formulation 1)

    Three doses will be administered intramuscularly, at Month 0, 2 and 6.

  • BiologicalPneumococcal vaccine GSK2189242A (formulation 2)

    Three doses will be administered intramuscularly, at Month 0, 2 and 6

  • BiologicalPneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

    Three doses will be administered intramuscularly, at Month 0, 2 and 6

  • BiologicalPneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

    Three doses will be administered intramuscularly, at Month 0, 2 and 6

  • BiologicalPneumococcal vaccine GSK1024850A

    Three doses will be administered intramuscularly, at Month 0, 2 and 6

06

What researchers measure

Primary outcomes

  1. Number of Subjects With Fever > 40.0°C (Rectal Temperature)

    The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

    Time frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination

Secondary outcomes

  1. 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 than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

    Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)

  2. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

    Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = 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 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)

  3. 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.

    Time frame: During the 31-day (Days 0-30) follow-up period after each primary dose

  4. 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.

    Time frame: During the 31-day (Days 0-30) follow-up period after the booster dose

  5. Number of Subjects With Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Time frame: During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)

  6. Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations

    Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.

    Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  7. Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations

    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

    Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  8. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes

    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.

    Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  9. Antibody Concentrations to Protein D (Anti-PD)

    Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).

    Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  10. Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity

    Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.

    Time frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

07

Results

Posted Oct 6, 2017

Participant flow

Participant flow — Overall Study
MilestoneGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Started5152525151
Completed5152525150
Not completed00001
Withdrew: Adverse event00001

Outcome measures

PrimaryNumber of Subjects With Fever > 40.0°C (Rectal Temperature)

The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

Time frame:
Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Reported as:
Count of participants · Participants
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
ParticipantsSynflorix GroupSynflorix/GSK 2189242A Group
Number of Subjects With Fever > 40.0°C (Rectal Temperature)01
Statistical analysis
  • Synflorix Group vs Synflorix/GSK 2189242A Group · Difference in percentage: 0.97 · 95% CI -6.1 to 5.32
PrimaryNumber of Subjects With Fever > 40.0°C (Rectal Temperature)

The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

Time frame:
Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Reported as:
Count of participants · Participants
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
ParticipantsSynflorix GroupGSK 2189242A Group
Number of Subjects With Fever > 40.0°C (Rectal Temperature)01
Statistical analysis
  • Synflorix Group vs GSK 2189242A Group · Difference in percentage: 0.97 · 95% CI -6.1 to 5.32
SecondaryNumber 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 than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

Time frame:
During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
ParticipantsGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Any Pain Dose 11815312326
Grade 3 Pain Dose 100124
Any Redness Dose 11720322825
Grade 3 Redness Dose 110542
Any Swelling Dose 185191719
Grade 3 Swelling Dose 100221
Any Pain Dose 21522242727
Grade 3 Pain Dose 200223
Any Redness Dose 22125232224
Grade 3 Redness Dose 211413
Any Swelling Dose 2119181116
Grade 3 Swelling Dose 200512
Any Pain Booster1822322625
Grade 3 Pain Booster00321
Any Redness Booster1920282221
Grade 3 Redness Booster22543
Any Swelling Booster118181513
Grade 3 Swelling Booster03313
SecondaryNumber of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = 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 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
ParticipantsGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Any Drowsiness Dose 11613242026
Grade 3 Drowsiness Dose 100000
Related Drowsiness Dose 166131016
Any Irritability Dose 12116312723
Grade 3 Irritability Dose 100000
Related Irritability Dose 169171614
Any Loss of appetite Dose 1157141214
Grade 3 Loss of appetite Dose 120100
Related Loss of appetite Dose 145937
Any Fever Dose 178141212
Grade 3 Fever Dose 101100
Related Fever Dose 132789
Any Drowsiness Dose 21216171523
Grade 3 Drowsiness Dose 200000
Related Drowsiness Dose 2611111018
Any Irritability Dose 21218222427
Grade 3 Irritability Dose 200001
Related Irritability Dose 2311171821
Any Loss of appetite Dose 281012913
Grade 3 Loss of appetite Dose 210000
Related Loss of appetite Dose 245957
Any Fever Dose 2912897
Grade 3 Fever Dose 200000
Related Fever Dose 226577
Any Drowsiness Booster1313181217
Grade 3 Drowsiness Booster00000
Related Drowsiness Booster79111011
Any Irritability Booster1517261719
Grade 3 Irritability Booster00011
Related Irritability Booster911151313
Any Loss of appetite Booster61013158
Grade 3 Loss of appetite Booster20111
Related Loss of appetite Booster44776
Any Fever Booster8101057
Grade 3 Fever Booster00000
Related Fever Booster53723
SecondaryNumber 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.

Time frame:
During the 31-day (Days 0-30) follow-up period after each primary dose
Reported as:
Count of participants · Participants
Number of Subjects With Unsolicited Adverse Events (AEs)
ParticipantsGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Number of Subjects With Unsolicited Adverse Events (AEs)2524312422
SecondaryNumber 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.

Time frame:
During the 31-day (Days 0-30) follow-up period after the booster dose
Reported as:
Count of participants · Participants
Number of Subjects With Unsolicited Adverse Events (AEs)
ParticipantsGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Number of Subjects With Unsolicited Adverse Events (AEs)14121349
SecondaryNumber of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame:
During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs)
ParticipantsGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Number of Subjects With Serious Adverse Events (SAEs)53504
SecondaryAnti-pneumococcal dPly and PhtD Proteins Antibody Concentrations

Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.

Time frame:
One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Reported as:
Geometric mean · LU/mL
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
LU/mLGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Anti-dPly, Post-dose 2135703.5 (95376.62 to 193081.3)148447.5 (101599.9 to 216896.7)32436.07 (25523.77 to 41220.35)57149.83 (44908.69 to 72727.64)3759.82 (2376.77 to 5947.68)
Anti-dPly, Pre-booster100811.4 (74005.55 to 137326.8)96552.52 (73753.5 to 126399.3)19573.55 (14948.37 to 25629.82)29592.91 (22065.25 to 39688.66)4654.16 (2879.42 to 7522.78)
Anti-dPly, Post-booster224726.2 (178187.6 to 283419.8)305912.3 (248087.9 to 377214.4)44123.43 (34299.98 to 56760.29)85805.02 (67740.53 to 108686.8)4553.43 (2878.04 to 7204.12)
Anti-PhtD, Post-dose 230402.84 (20723.61 to 44602.88)35043.91 (24164.16 to 50822.19)23438.06 (16617.86 to 33057.36)22141.18 (15065.44 to 32540.15)3795.68 (2268.23 to 6351.73)
Anti-PhtD, Pre-booster24350.58 (17056.09 to 34764.74)23918.77 (17724.59 to 32277.63)14375.59 (9338.31 to 22130.1)12721.01 (8498 to 19042.62)4814.97 (2881.25 to 8046.46)
Anti-PhtD, Post-booster65584.24 (50985.27 to 84363.43)77312.07 (58589.49 to 102017.6)32609.19 (23615.58 to 45027.88)36098.18 (26620.97 to 48949.34)5072.43 (3023.97 to 8508.53)
SecondaryAnti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations

Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

Time frame:
One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Reported as:
Geometric mean · µg/mL
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
µg/mLGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Anti-1, Post-Dose 20.04 (0.03 to 0.05)0.05 (0.04 to 0.06)2.5 (2.01 to 3.11)2.08 (1.56 to 2.77)2.13 (1.62 to 2.79)
Anti-1, Pre-booster0.05 (0.03 to 0.06)0.05 (0.04 to 0.07)0.87 (0.68 to 1.12)0.75 (0.57 to 0.99)0.73 (0.55 to 0.97)
Anti-1, Post-booster0.04 (0.03 to 0.06)0.05 (0.04 to 0.08)2.69 (2.13 to 3.39)2.47 (2.03 to 3)2.4 (1.85 to 3.12)
Anti-4, Post-Dose 20.05 (0.03 to 0.08)0.03 (0.02 to 0.03)6.42 (5.23 to 7.87)6.6 (5.12 to 8.52)5.67 (4.56 to 7.06)
Anti-4, Pre-booster0.05 (0.03 to 0.07)0.03 (0.03 to 0.03)2.3 (1.82 to 2.91)2.36 (1.79 to 3.11)2.11 (1.68 to 2.64)
Anti-4, Post-booster0.05 (0.03 to 0.07)0.04 (0.03 to 0.05)5.26 (4.14 to 6.69)5.61 (4.46 to 7.07)5.18 (4.05 to 6.63)
Anti-5, Post-Dose 20.06 (0.04 to 0.08)0.06 (0.05 to 0.08)2.42 (1.85 to 3.17)2.41 (1.85 to 3.13)2.36 (1.88 to 2.97)
Anti-5, Pre-booster0.07 (0.05 to 0.1)0.06 (0.05 to 0.08)1.08 (0.83 to 1.41)1.05 (0.81 to 1.36)1.18 (0.94 to 1.48)
Anti-5, Post-booster0.07 (0.05 to 0.09)0.07 (0.05 to 0.09)3.57 (2.79 to 4.57)3.45 (2.7 to 4.41)3.84 (2.98 to 4.95)
Anti-6B, Post-Dose 20.04 (0.03 to 0.05)0.03 (0.02 to 0.03)0.55 (0.37 to 0.81)0.48 (0.32 to 0.72)0.55 (0.39 to 0.78)
Anti-6B, Pre-booster0.04 (0.03 to 0.05)0.04 (0.03 to 0.05)0.39 (0.28 to 0.54)0.42 (0.3 to 0.59)0.46 (0.34 to 0.62)
Anti-6B, Post-booster0.04 (0.03 to 0.06)0.04 (0.03 to 0.06)1.08 (0.74 to 1.57)1.14 (0.83 to 1.57)1.08 (0.78 to 1.52)
Anti-7F, Post-Dose 20.04 (0.03 to 0.06)0.04 (0.03 to 0.04)5.03 (4.16 to 6.09)4.73 (3.89 to 5.74)3.72 (3.17 to 4.36)
Anti-7F, Pre-booster0.04 (0.03 to 0.06)0.03 (0.03 to 0.04)2.6 (2.14 to 3.15)2.36 (1.94 to 2.86)2.14 (1.82 to 2.51)
Anti-7F, Post-booster0.04 (0.03 to 0.06)0.04 (0.03 to 0.05)5.9 (4.83 to 7.2)5.25 (4.36 to 6.32)4.65 (3.77 to 5.72)
Anti-9V, Post-Dose 20.04 (0.03 to 0.06)0.03 (0.02 to 0.03)2.81 (2.24 to 3.51)2.49 (1.95 to 3.19)1.55 (1.21 to 2)
Anti-9V, Pre-booster0.04 (0.03 to 0.05)0.03 (0.03 to 0.04)1.44 (1.15 to 1.81)1.26 (0.94 to 1.67)0.95 (0.73 to 1.24)
Anti-9V, Post-booster0.04 (0.03 to 0.06)0.03 (0.02 to 0.04)3.13 (2.48 to 3.93)3.21 (2.45 to 4.19)2.18 (1.71 to 2.79)
Anti-14, Post-Dose 20.1 (0.07 to 0.14)0.09 (0.06 to 0.14)5.18 (3.91 to 6.86)3.78 (2.92 to 4.91)4.63 (3.71 to 5.77)
Anti-14, Pre-booster0.11 (0.08 to 0.17)0.11 (0.07 to 0.18)2.86 (2.25 to 3.65)2.3 (1.81 to 2.91)2.71 (2.17 to 3.38)
Anti-14, Post-booster0.13 (0.09 to 0.18)0.16 (0.1 to 0.26)7.74 (6.03 to 9.94)6.62 (5.22 to 8.4)5.98 (4.68 to 7.63)
Anti-18C, Post-Dose 20.04 (0.03 to 0.06)0.04 (0.03 to 0.05)13.92 (10.75 to 18.03)16.92 (13.61 to 21.03)12.56 (9.8 to 16.1)
Anti-18C, Pre-booster0.05 (0.03 to 0.07)0.04 (0.03 to 0.05)4.94 (3.83 to 6.38)5.51 (4.3 to 7.05)4.79 (3.69 to 6.21)
Anti-18C, Post-booster0.05 (0.03 to 0.07)0.05 (0.03 to 0.07)16.12 (12.2 to 21.32)21.98 (16.67 to 28.99)14.62 (10.9 to 19.6)
Anti-19F, Post-Dose 20.05 (0.03 to 0.08)0.06 (0.03 to 0.12)8.6 (6.37 to 11.63)10.08 (7.21 to 14.09)8.87 (6.2 to 12.7)
Anti-19F, Pre-booster0.06 (0.04 to 0.1)0.05 (0.03 to 0.09)4.15 (2.94 to 5.85)4.72 (3.54 to 6.3)4.33 (3.06 to 6.12)
Anti-19F, Post-booster0.06 (0.04 to 0.09)0.07 (0.04 to 0.13)10.46 (7.35 to 14.88)14.38 (10.53 to 19.63)11.32 (7.94 to 16.13)
Anti-23F, Post-Dose 20.03 (0.03 to 0.04)0.04 (0.03 to 0.05)1.19 (0.82 to 1.74)0.91 (0.62 to 1.33)0.73 (0.54 to 0.98)
Anti-23F, Pre-booster0.03 (0.03 to 0.04)0.04 (0.03 to 0.06)0.71 (0.5 to 0.99)0.62 (0.45 to 0.85)0.51 (0.39 to 0.67)
Anti-23F, Post-booster0.03 (0.03 to 0.04)0.05 (0.03 to 0.06)1.92 (1.42 to 2.6)2.04 (1.56 to 2.65)1.47 (1.04 to 2.06)
Anti-6A, Post-Dose 20.04 (0.03 to 0.07)0.03 (0.03 to 0.04)0.32 (0.2 to 0.51)0.27 (0.16 to 0.45)0.31 (0.2 to 0.48)
Anti-6A, Pre-booster0.04 (0.03 to 0.06)0.04 (0.03 to 0.04)0.24 (0.17 to 0.34)0.24 (0.15 to 0.38)0.27 (0.18 to 0.4)
Anti-6A, Post-booster0.04 (0.03 to 0.06)0.04 (0.03 to 0.06)0.53 (0.35 to 0.79)0.56 (0.36 to 0.87)0.58 (0.37 to 0.9)
Anti-19A, Post-Dose 20.07 (0.04 to 0.12)0.05 (0.03 to 0.06)1.08 (0.71 to 1.62)0.97 (0.63 to 1.48)0.93 (0.61 to 1.43)
Anti-19A, Pre-booster0.07 (0.04 to 0.1)0.05 (0.04 to 0.06)0.85 (0.61 to 1.17)0.68 (0.47 to 0.98)0.62 (0.42 to 0.93)
Anti-19A, Post-booster0.07 (0.05 to 0.11)0.05 (0.04 to 0.07)2.76 (1.92 to 3.96)2.98 (2.08 to 4.26)2.06 (1.3 to 3.25)
SecondaryOpsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes

Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.

Time frame:
One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Reported as:
Geometric mean · Titers
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
TitersGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
OPSONO-1, Post-Dose 24 (4 to 4)5.4 (3.8 to 7.8)71.8 (40.9 to 126.1)48.2 (26.5 to 87.6)90 (52.9 to 153)
OPSONO-1, Pre-booster4 (4 to 4)4.3 (3.7 to 5)23 (13.1 to 40.3)12.4 (7.6 to 20.3)19.3 (11.1 to 33.6)
OPSONO-1, Post-booster5.2 (4 to 6.9)8.1 (4.8 to 13.7)169.5 (96.1 to 298.8)200 (138.2 to 289.4)206.9 (123.1 to 347.5)
OPSONO-4, Post-Dose 27 (3.1 to 15.6)8.9 (4.5 to 17.6)1260.2 (856.1 to 1855.2)1197.9 (784.1 to 1830.2)1220.4 (913.8 to 1629.9)
OPSONO-4, Pre-booster12.6 (5.6 to 28.4)16.2 (7 to 37.2)247.9 (117.4 to 523.2)259.9 (120.6 to 560)478.9 (309.3 to 741.3)
OPSONO-4, Post-booster15.5 (6.1 to 39.5)17.8 (7.3 to 43.4)1206.2 (888.9 to 1636.8)1385 (974.5 to 1968.4)1476 (1076 to 2024.6)
OPSONO-5, Post-Dose 24 (4 to 4)4.7 (3.4 to 6.5)43.8 (27.1 to 70.8)37.3 (21.7 to 64)42 (26.6 to 66.4)
OPSONO-5, Pre-booster4.5 (3.5 to 5.8)4 (4 to 4)12.8 (8.2 to 19.9)14.8 (9.6 to 23)17 (10.9 to 26.4)
OPSONO-5, Post-booster4 (4 to 4)5.1 (3.8 to 6.7)99.3 (62.1 to 158.8)110.4 (73.1 to 166.8)160.7 (113 to 228.7)
OPSONO-6B, Post-Dose 215 (4.2 to 53.1)23.4 (6.1 to 90.3)361.9 (120 to 1091.7)527.5 (202.6 to 1372.9)915.3 (543.4 to 1541.8)
OPSONO-6B, Pre-booster56.7 (16.2 to 198.4)61.6 (19.2 to 197.3)213.8 (79 to 578.1)513.1 (243.9 to 1079.6)371.9 (172.5 to 801.8)
OPSONO-6B, Post-booster26.1 (7.7 to 88.7)30.8 (11.2 to 84.7)804.6 (343.5 to 1884.9)982.7 (527.6 to 1830.4)1523.1 (875.8 to 2649)
OPSONO-7F, Post-Dose 2734.6 (369.7 to 1459.6)807.4 (445 to 1465.2)5703.7 (4143.6 to 7851.2)4936.6 (3320.7 to 7338.7)6154.4 (4244.4 to 8923.7)
OPSONO-7F, Pre-booster670.4 (317.5 to 1415.6)462.3 (187.5 to 1139.8)2450.1 (1637.4 to 3666.2)2713.5 (1836.1 to 4010.1)3844.5 (2725.7 to 5422.4)
OPSONO-7F, Post-booster936.8 (510 to 1720.7)785.5 (428 to 1441.6)4109.3 (3086.9 to 5470.3)5730.4 (4262 to 7704.7)7404.7 (5271.1 to 10401.8)
OPSONO-9V, Post-Dose 226.5 (8.2 to 85.9)50.1 (17.5 to 143.7)4455 (2803.3 to 7079.9)3542.8 (2271.5 to 5525.5)3947.2 (2612.7 to 5963.5)
OPSONO-9V, Pre-booster172.4 (68.9 to 431.4)172 (57.6 to 513.2)2126.1 (1140.2 to 3964.4)2622.4 (1786.7 to 3849)3450 (2357.5 to 5048.7)
OPSONO-9V, Post-booster173.5 (59.1 to 509.8)137.6 (51.7 to 366)4643.1 (3418.3 to 6306.9)5802.4 (4453 to 7560.8)6016.6 (4617.2 to 7840)
OPSONO-14, Post-Dose 221.1 (6.7 to 66.8)11.9 (4.7 to 30.4)3324.8 (2324.8 to 4754.8)2580.7 (1788.4 to 3724)2487.6 (1703.4 to 3632.7)
OPSONO-14, Pre-booster21 (8.5 to 51.6)27.9 (10.4 to 75.1)1390.5 (615.7 to 3140.4)1725.8 (972.1 to 3064)1776.6 (1009.5 to 3126.5)
OPSONO-14, Post-booster32.3 (11.5 to 90.9)46.7 (17 to 127.8)2911.6 (1841.3 to 4604)3729.8 (2693.2 to 5165.4)3094 (2353.3 to 4068)
OPSONO-18C, Post-Dose 24 (4 to 4)7.4 (3.7 to 15.1)1398.3 (810.6 to 2412)2538.4 (1787.3 to 3605)1905.4 (1271.4 to 2855.6)
OPSONO-18C, Pre-booster5.4 (3.4 to 8.3)5 (3.7 to 6.8)420.1 (192.8 to 915.3)1041 (699.6 to 1548.9)766.4 (468.4 to 1253.8)
OPSONO-18C, Post-booster6 (3.3 to 10.7)8 (4.4 to 14.6)1764.6 (1243.6 to 2503.8)2640.6 (2083.3 to 3346.8)2123.4 (1493 to 3020.1)
OPSONO-19F, Pre-booster5 (3.1 to 8.2)8 (4.3 to 14.7)794.3 (476.6 to 1324)420.7 (197.4 to 896.4)625.4 (266.5 to 1467.7)
OPSONO-19F, Post-booster4.9 (3.5 to 6.8)4.4 (3.7 to 5.2)173.3 (86.1 to 349)210.1 (118.4 to 373)260.7 (138 to 492.5)
OPSONO-19F, Post-Dose 25.6 (3.4 to 9.1)7.3 (4.3 to 12.6)1248.5 (740.4 to 2105.3)1823.7 (1252.9 to 2654.5)1625.3 (931.7 to 2835.3)
OPSONO-23F, Post-Dose 217.9 (5.1 to 62.9)107.8 (28.1 to 412.8)1735.5 (833.6 to 3613.3)3621.8 (2431.4 to 5395.2)2502.5 (1610.5 to 3888.6)
OPSONO-23F, Pre-booster23.2 (7.6 to 70.3)136.3 (36.1 to 514.6)989.7 (419.2 to 2336.8)1635.9 (691.7 to 3868.8)897.4 (381.6 to 2110.4)
OPSONO-23F, Post-booster68.6 (17.3 to 271.2)106.7 (28.5 to 399.4)3598.5 (2422.2 to 5345.9)6108 (4335.9 to 8604.5)5296.1 (3857.9 to 7270.4)
OPSONO-6A, Post-Dose 29.3 (3.5 to 24.7)5.7 (3.4 to 9.5)225.3 (83.3 to 608.8)186.2 (55.3 to 627.2)364.5 (158.7 to 837.1)
OPSONO-6A, Pre-booster18.4 (7.6 to 44.5)9.4 (4.5 to 19.5)58.9 (21.6 to 160.3)99.4 (39.9 to 247.8)221.7 (93.8 to 524)
OPSONO-6A, Post-booster11.8 (4.7 to 29.5)17.3 (7.9 to 37.9)308 (141 to 672.9)348.2 (154.9 to 782.5)554.3 (248.3 to 1237.6)
OPSONO-19A, Post-Dose 25.8 (3.4 to 9.9)4.6 (3.7 to 5.6)246 (109.7 to 551.7)363.2 (202.1 to 652.8)349.9 (177.1 to 691.6)
OPSONO-19A, Pre-booster6 (4 to 9.1)4.5 (3.8 to 5.3)56.7 (25.2 to 127.9)76.4 (36.3 to 160.7)87.8 (40.6 to 189.7)
OPSONO-19A, Post-booster6.7 (4.3 to 10.3)6.3 (4.4 to 9.1)746.3 (407.8 to 1365.6)989.3 (652.5 to 1500)725.9 (367.8 to 1432.6)
SecondaryAntibody Concentrations to Protein D (Anti-PD)

Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).

Time frame:
One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Reported as:
Geometric mean · LU/mL
Antibody Concentrations to Protein D (Anti-PD)
LU/mLGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Anti-PD, Post-Dose 290.9 (71.1 to 116.3)100.4 (76.3 to 132.1)1105.4 (833.7 to 1465.7)600.2 (426.5 to 844.7)860 (659.2 to 1121.9)
Anti-PD, Pre-booster89.1 (71.8 to 110.7)118.2 (89.6 to 155.9)734.6 (523.9 to 1030.1)463 (330.2 to 649.3)691.8 (527.6 to 907.1)
Anti-PD, Post-booster97.9 (78 to 122.9)130.6 (93.1 to 183.3)1882.6 (1407.4 to 2518.1)1474.6 (1103.7 to 1970.3)1963.8 (1560.1 to 2472)
SecondaryLevel of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity

Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.

Time frame:
One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Reported as:
Geometric mean · Titers
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
TitersGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Anti-Hem-dPly, Post-Dose 23080 (2555.3 to 3712.5)2988.7 (2410.1 to 3706.2)1278.9 (1048.2 to 1560.3)1814 (1495.3 to 2200.8)913.2 (699.1 to 1192.8)
Anti-Hem-dPly, Pre-booster2441.1 (1867.1 to 3191.7)2193.7 (1737.3 to 2770)1141.5 (950.6 to 1370.6)1344.2 (1087.6 to 1661.3)995.9 (788.3 to 1258.2)
Anti-Hem-dPly, Post-booster4332.4 (3327.6 to 5640.4)5931.9 (4744.5 to 7416.4)1346.2 (1068.2 to 1696.5)2388.3 (1830.6 to 3115.9)818.6 (662.5 to 1011.5)

Adverse events

Collected over Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK 2189242A-LD Group0/51 (0%)5/51 (9.8%)47/51 (92.2%)
GSK 2189242A-HD Group0/52 (0%)3/52 (5.8%)49/52 (94.2%)
Synflorix/GSK 2189242A-LD Group0/52 (0%)5/52 (9.6%)49/52 (94.2%)
Synflorix/GSK 2189242A-HD Group0/51 (0%)0/51 (0%)49/51 (96.1%)
Synflorix Group0/51 (0%)4/51 (7.8%)49/51 (96.1%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
HaematomaVascular disorders1/510/520/520/510/51
ConcussionInjury, poisoning and procedural complications0/510/521/520/511/51
Foreign bodyInjury, poisoning and procedural complications1/510/520/520/510/51
Open woundInjury, poisoning and procedural complications0/510/520/520/511/51
Febrile convulsionNervous system disorders0/510/520/520/511/51
PyrexiaGeneral disorders0/510/520/520/511/51
Affective disorderPsychiatric disorders1/510/520/520/510/51
Gastroenteritis salmonellaInfections and infestations1/510/520/520/511/51
BronchitisInfections and infestations1/510/520/520/510/51
GastroenteritisInfections and infestations0/510/520/520/511/51
Most frequent other events
Showing 10 of 25
Most frequent other events
EventGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix Group
Irritability PrimaryGeneral disorders26/5123/5235/5236/5135/51
Redness PrimaryGeneral disorders24/5130/5236/5233/5130/51
Drowsiness PrimaryGeneral disorders25/5121/5234/5228/5135/51
Pain PrimaryGeneral disorders27/5128/5234/5233/5134/51
Pain BoosterGeneral disorders18/5122/5232/5226/5125/51
Redness BoosterGeneral disorders19/5120/5228/5222/5121/51
Swelling PrimaryGeneral disorders17/5111/5225/5221/5126/51
Irritability BoosterGeneral disorders15/5117/5226/5217/5119/51
Loss of appetite PrimaryGeneral disorders19/5115/5220/5219/5123/51
Temperature/Rectally PrimaryGeneral disorders13/5116/5218/5218/5117/51

Baseline characteristics

Age, Continuous
Age, Continuous(Months)GSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix GroupTotal
Mean17 ± 3.616.7 ± 3.8117.1 ± 4.0316.8 ± 3.9616.3 ± 4.1816.78 ± 3.90
Sex: Female, Male
Sex: Female, Male(Participants)GSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix GroupTotal
Female2522232928127
Male2630292223130
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)GSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD GroupSynflorix/GSK 2189242A-HD GroupSynflorix GroupTotal
White-Caucasian/European heritage5152515149254
White-Arabic/North African heritage001023
08

Study locations

10 sites
  • GSK Investigational Site
    Chomutov, 43003, Czechia
  • GSK Investigational Site
    Decin, 405 01, Czechia
  • GSK Investigational Site
    Nachod, 547 01, Czechia
  • GSK Investigational Site
    Odolena voda, 25070, Czechia
  • GSK Investigational Site
    Ostrava - Poruba, 70868, Czechia
  • GSK Investigational Site
    Pardubice, 532 03, Czechia
  • GSK Investigational Site
    Plzen, 305 99, Czechia
  • GSK Investigational Site
    Praha 4, 140 00, Czechia
  • GSK Investigational Site
    Praha 6, 1600, Czechia
  • GSK Investigational Site
    Znojmo, 669 00, Czechia
09

References and documents

Publications

  • Prymula R, Pazdiora P, Traskine M, Ruggeberg JU, Borys D. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial. Vaccine. 2014 May 23;32(25):3025-34. doi: 10.1016/j.vaccine.2014.03.066. Epub 2014 Apr 1. PubMed 24699466 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00985751
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 28, 2009
Start date
Nov 24, 2009
Primary completion
Oct 12, 2010
Completion
Mar 2, 2011
Results posted
Oct 6, 2017
Last update
Nov 5, 2020

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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