Infections, StreptococcalPhase 3NCT01119625
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
A Phase 3 study testing Pneumococcal vaccine GSK1024850A and Infanrix-IPV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 3 sites in Singapore.
Trial summary
This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. Read more about this study
- Who is it for?
- Ages 18 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine GSK1024850A and Infanrix-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 3 sitesSingapore
- Study dates
- 12 Jul 2010to 17 Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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, 18 and 21 months of age at the time of booster vaccination.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- 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.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
- Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
Show all 17Show fewer
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
- Fever at the time of vaccination.
- Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
- Acute disease at the time of enrolment.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Child in care.
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
GSK Investigational Site
Singapore, 119074
GSK Investigational Site
Singapore, 229899
GSK Investigational Site
Singapore, 688846
About this study
Official title: Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine
This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal vaccine GSK1024850A, Infanrix-IPV/Hib
- Keywords
- safety, Streptococcus pneumoniae, immunogenicity, Pneumococcal conjugate vaccine, Haemophilus influenzae
- Medical subject headings
- Streptococcal Infections, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal vaccine GSK1024850ABiological
Intramuscular injection, one dose
Infanrix-IPV/HibBiological
Intramuscular injection, one dose
| Study group | Role | What they receive |
|---|---|---|
| Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group | Experimental | children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Infanrix-IPV/Hib |
| Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group | Active comparator | children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Infanrix-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Measured: Before booster vaccination at Month 0
Concentrations of Antibodies Against Protein D (PD).
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Measured: Before booster vaccination at Month 0
Secondary outcomes (18)
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm).
Measured: Within 4 days (Days 0-3) after booster vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).
Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.
Related = solicited symptom assessed by the investigator as causally related to study vaccination.
Measured: Within 4 days (Days 0-3) after booster vaccination.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Measured: Within 31 days (Days 0-30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
Opsonophagocytic activity (OPA) testing was not performed.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsonophagocytic activity (OPA) testing was not performed.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Measured: Before booster vaccination at Month 0
Concentrations of Antibodies Against Diphtheria and Tetanus.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Measured: Before booster vaccination at Month 0
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Measured: Before booster vaccination at Month 0
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Measured: Before booster vaccination at Month 0
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Measured: Before booster vaccination at Month 0
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Protein D (PD).
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Diphtheria and Tetanus.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Measured: Before and one month after booster vaccination (at Month 0 and Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study start12 Jul 2010
- Primary completion17 Feb 2011
- Study completion17 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119625
- Sponsor's protocol ID
- 113266
- Status last verified
- Sep 2016
- First submitted
- 22 Apr 2010
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
PubMed 25278086
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine
- ClinicalTrials.gov ID
- NCT01119625
- Acronym / sponsor ID
- 113266
- Conditions
- Infections, Streptococcal
- Keywords
- safety, Streptococcus pneumoniae, immunogenicity, Pneumococcal conjugate vaccine, Haemophilus influenzae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2010
- Primary completion
- 17 Feb 2011 (actual)
- Study completion
- 17 Feb 2011 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Infanrix-IPV/Hibchildren primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
| Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group | Active comparator | Biological: Pneumococcal vaccine GSK1024850A, Biological: Infanrix-IPV/Hibchildren primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh. |
Who may qualify
- Ages
- 18 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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, 18 and 21 months of age at the time of booster vaccination.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- 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.
Key exclusion criteria (17 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal vaccine GSK1024850AIntramuscular injection, one dose | Biological | Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group, Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group |
| Infanrix-IPV/HibIntramuscular injection, one dose | Biological | Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group, Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group |
Primary outcome
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Time frame: Before booster vaccination at Month 0
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Protein D (PD).
Time frame: Before booster vaccination at Month 0
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
18 secondary outcomes
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Time frame: Within 4 days (Days 0-3) after booster vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Time frame: Within 4 days (Days 0-3) after booster vaccination.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Time frame: Within 31 days (Days 0-30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Time frame: Before booster vaccination at Month 0
Concentrations of Antibodies Against Diphtheria and Tetanus.
Time frame: Before booster vaccination at Month 0
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Time frame: Before booster vaccination at Month 0
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Time frame: Before booster vaccination at Month 0
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Time frame: Before booster vaccination at Month 0
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Protein D (PD).
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Diphtheria and Tetanus.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Time frame: Before and one month after booster vaccination (at Month 0 and Month 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25278086Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Infections, Streptococcal
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal vaccine GSK1024850A and Infanrix-IPV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. (time frame: Before booster vaccination at Month 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.