Infections, StreptococcalPhase 4NCT01235949

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

A Phase 4 study testing GSK1024850A (SynflorixTM), Infanrix hexa and Infanrix-IPV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 23 sites in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate… Read more about this study

Who is it for?: Ages 12 to 16 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal
What is being tested?: GSK1024850A (SynflorixTM), Infanrix hexa and Infanrix-IPV/Hib
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 850 participants
Where: 23 sitesRomania
Study dates: 12 Nov 2010to 8 Dec 2012
Phase: Phase 4
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 12 to 16 weeks
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.
A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Who cannot join

Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, 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 (.
Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.

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Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
History of any seizures or progressive neurological disease.
Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
Body weight < 5 kg at the time of enrolment.
Child in care.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Romania23 sites

GSK Investigational Site
Bacau, 600316
GSK Investigational Site
Brăila, 810289
GSK Investigational Site
Brăila, 810346
GSK Investigational Site
Brasov, 500063
GSK Investigational Site
Brasov, 500260
GSK Investigational Site
Brasov, 500366
GSK Investigational Site
Bucharest, 030442
GSK Investigational Site
Bucharest, 050734
GSK Investigational Site
Bucharest, 051821
GSK Investigational Site
Bucharest, 077190
GSK Investigational Site
Calarasi, 910160
GSK Investigational Site
Cluj-Napoca, 400217
GSK Investigational Site
Constanța, 900709
GSK Investigational Site
Constanța, 900721
GSK Investigational Site
Galati, 800099
GSK Investigational Site
Galati, 800179
GSK Investigational Site
Galati, 800235
GSK Investigational Site
Galati, 800322
GSK Investigational Site
Galati, 800394
GSK Investigational Site
Iași, 700115
GSK Investigational Site
Pantelimon, 77145
GSK Investigational Site
Sibiu, 550166
GSK Investigational Site
Timișoara, 300593

Other trials in Romania

About this study

Official title: Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

Conditions: Infections, Streptococcal
Being tested: GSK1024850A (SynflorixTM), Infanrix hexa, Infanrix-IPV/Hib, Ibuprofen, Paracetamol
Keywords: Pneumococcal vaccine, Immunogenicity, Safety, Fever, Primary vaccination, Booster vaccination, Pneumococcal disease, Prophylactic antipyretic
Medical subject headings: Streptococcal Infections, Fever, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1024850A (SynflorixTM)Biological
Intramuscular injection, 4 doses
Infanrix hexaBiological
Intramuscular injection, 3 doses
Infanrix-IPV/HibBiological
Intramuscular injection, 1 dose
IbuprofenDrug
Also called Nurofen for Children
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
ParacetamolDrug
Also called Panadol Baby
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Study groups in NCT01235949
Study group	Role	What they receive
Group IIBU	Experimental	Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group DIBU	Active comparator	Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group NIBU	Active comparator	No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group IPARA	Experimental	Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Paracetamol
Group DPARA	Experimental	Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Paracetamol
Group NPARA	Active comparator	No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group IIBU-IIBU	Experimental	1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group IIBU-DIBU	Experimental	1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group IIBU-NIBU	Experimental	1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group DIBU-IIBU	Experimental	1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group DIBU-DIBU	Experimental	1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group DIBU-NIBU	Experimental	1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group NIBU-IIBU	Experimental	1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group NIBU-DIBU	Experimental	1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Ibuprofen
Group NIBU-NIBU	Active comparator	1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group IPARA-NPARA	Experimental	subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib
Group DPARA-IPARA	Experimental	subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Paracetamol
Group NPARA-IPARA	Experimental	subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination Receives: Biological: GSK1024850A (SynflorixTM); Biological: Infanrix hexa; Biological: Infanrix-IPV/Hib; Drug: Paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
Measured: One month after primary immunization (At Month 3)
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Measured: One month after primary immunization (At Month 3)
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.
Measured: One month after primary immunization (At Month 3)

Secondary outcomes (22)

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Measured: One month after primary immunization (At Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence 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 millimeters (mm).
Measured: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence 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 millimeters (mm).
Measured: Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with 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 = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with 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 = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any 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.
Measured: During the entire study period (Month 0 to 10)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within 31-days (Day 0-30) following each primary vaccination dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: Within 31-days (Day 0-30) following booster vaccination
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.
Measured: One month after primary immunization (Month 3)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (>) 1.0 E10.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Measured: One month after primary immunization (Month 3)
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.
Measured: One month after primary immunization (Month 3)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Measured: One month after primary immunization (Month 3)
Antibody Concentrations Against Hepatitis B Surface Antigen
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.
Measured: One month after primary immunization (Month 3)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.
Measured: One month after primary immunization (Month 3)
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.
Measured: Prior to (Month 9) and one month after booster vaccination (Month 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 20108 Dec 2012

First posted8 Nov 2010 (estimated)
Study start12 Nov 2010
Primary completion28 Mar 2012
Study completion8 Dec 2012

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 850 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01235949
Sponsor's protocol ID: 112921
Other IDs: 2010-019761-28
Status last verified: Apr 2019
First submitted: 4 Nov 2010
Last updated: 10 May 2019
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

Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.
PubMed 27541270

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines
ClinicalTrials.gov ID: NCT01235949
Acronym / sponsor ID: 112921
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine, Immunogenicity, Safety, Fever, Primary vaccination, Booster vaccination, Pneumococcal disease, Prophylactic antipyretic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 850 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 12 Nov 2010 (actual)
Primary completion: 28 Mar 2012 (actual)
Study completion: 8 Dec 2012 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 31 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 18

Arm	Type	Receives
Group IIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: IbuprofenImmediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose
Group DIBU	Active comparator	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: IbuprofenDelayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose
Group NIBU	Active comparator	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/HibNo ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose
Group IPARA	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: ParacetamolImmediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose
Group DPARA	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: ParacetamolDelayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose
Group NPARA	Active comparator	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/HibNo paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose
Group IIBU-IIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination
Group IIBU-DIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination
Group IIBU-NIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group DIBU-IIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination
Group DIBU-DIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination
Group DIBU-NIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group NIBU-IIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination
Group NIBU-DIBU	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Ibuprofen1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination
Group NIBU-NIBU	Active comparator	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group IPARA-NPARA	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hibsubjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination
Group DPARA-IPARA	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Paracetamolsubjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination
Group NPARA-IPARA	Experimental	Biological: GSK1024850A (SynflorixTM), Biological: Infanrix hexa, Biological: Infanrix-IPV/Hib, Drug: Paracetamolsubjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination

Who may qualify

Ages: 12 to 16 weeks
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.
A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Key exclusion criteria (19 listed)

Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, 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 (.
Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

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
GSK1024850A (SynflorixTM)Intramuscular injection, 4 doses	Biological	Group DIBU, Group DIBU-DIBU, Group DIBU-IIBU, Group DIBU-NIBU, Group DPARA, Group DPARA-IPARA, Group IIBU, Group IIBU-DIBU, Group IIBU-IIBU, Group IIBU-NIBU, Group IPARA, Group IPARA-NPARA, Group NIBU, Group NIBU-DIBU, Group NIBU-IIBU, Group NIBU-NIBU, Group NPARA, Group NPARA-IPARA
Infanrix hexaIntramuscular injection, 3 doses	Biological	Group DIBU, Group DIBU-DIBU, Group DIBU-IIBU, Group DIBU-NIBU, Group DPARA, Group DPARA-IPARA, Group IIBU, Group IIBU-DIBU, Group IIBU-IIBU, Group IIBU-NIBU, Group IPARA, Group IPARA-NPARA, Group NIBU, Group NIBU-DIBU, Group NIBU-IIBU, Group NIBU-NIBU, Group NPARA, Group NPARA-IPARA
Infanrix-IPV/HibIntramuscular injection, 1 dose	Biological	Group DIBU, Group DIBU-DIBU, Group DIBU-IIBU, Group DIBU-NIBU, Group DPARA, Group DPARA-IPARA, Group IIBU, Group IIBU-DIBU, Group IIBU-IIBU, Group IIBU-NIBU, Group IPARA, Group IPARA-NPARA, Group NIBU, Group NIBU-DIBU, Group NIBU-IIBU, Group NIBU-NIBU, Group NPARA, Group NPARA-IPARA
IbuprofenAlso: Nurofen for ChildrenOral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight	Drug	Group DIBU, Group DIBU-DIBU, Group DIBU-IIBU, Group IIBU, Group IIBU-IIBU, Group IIBU-NIBU, Group NIBU-DIBU, Group NIBU-IIBU
ParacetamolAlso: Panadol BabyOral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight	Drug	Group DPARA, Group DPARA-IPARA, Group IPARA, Group NPARA-IPARA

Primary outcome

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Time frame: One month after primary immunization (At Month 3)
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Time frame: One month after primary immunization (At Month 3)
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
Antibody Concentrations Against Protein D (Anti-PD)
Time frame: One month after primary immunization (At Month 3)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.

22 secondary outcomes

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: One month after primary immunization (At Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: During the entire study period (Month 0 to 10)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31-days (Day 0-30) following each primary vaccination dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31-days (Day 0-30) following booster vaccination
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Time frame: One month after primary immunization (Month 3)
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Protein D (Anti-PD)
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
Time frame: One month after primary immunization (Month 3)
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Time frame: One month after primary immunization (Month 3)
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)
Time frame: One month after primary immunization (Month 3)
Antibody Concentrations Against Hepatitis B Surface Antigen
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: One month after primary immunization (Month 3)
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)
Antibody Titers Against Poliovirus Type 1, 2 and 3
Time frame: One month after primary immunization (Month 3)
Antibody Titers Against Poliovirus Type 1, 2 and 3
Time frame: Prior to (Month 9) and one month after booster vaccination (Month 10)

Results and safety

Results posted to the registry on 31 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IIBU Group	198	194
DIBU Group	198	195
NIBU Group	199	196
IPARA Group	71	69
DPARA Group	72	71
NPARA Group	74	67
IIBU-IIBU Group	0	0
IIBU-DIBU Group	0	0
IIBU-NIBU Group	0	0
DIBU-IIBU Group	0	0
DIBU-DIBU Group	0	0
DIBU-NIBU Group	0	0
NIBU-IIBU Group	0	0
NIBU-DIBU Group	0	0
NIBU-NIBU Group	0	0
IPARA-NPARA Group	0	0
DPARA-IPARA Group	0	0
NPARA-IPARA Group	0	0

Primary outcome: Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

Time frame: One month after primary immunization (At Month 3). Count of participants. Unit: Participants

Measure	IIBU Group n = 154	DIBU Group n = 158	NIBU Group n = 164	IPARA Group n = 55	DPARA Group n = 55	NPARA Group n = 56
Anti-1	144	155	160	52	50	55
Anti-4	145	155	158	53	51	56
Anti-5	143	154	156	53	50	54
Anti-6B	121	135	133	42	37	48
Anti-7F	153	157	164	55	55	56
Anti-9V	144	153	155	53	50	53
Anti-14	144	153	154	53	50	53
Anti-18C	143	153	155	52	50	54

IIBU Group vs NIBU Group: Difference in percentages: -0.62 (98.25% CI -4.52 to 3.17)
IIBU Group vs NIBU Group: Difference in percentages: 0.06 (98.25% CI -3.94 to 4.38)
IIBU Group vs NIBU Group: Difference in percentages: -0.64 (98.25% CI -4.63 to 3.19)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Primary outcome: Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Time frame: One month after primary immunization (At Month 3). Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	IIBU Group n = 154	DIBU Group n = 158	NIBU Group n = 164	IPARA Group n = 55	DPARA Group n = 55	NPARA Group n = 56
Anti-1	1.82 (1.59 to 2.09)	1.71 (1.49 to 1.95)	1.9 (1.67 to 2.17)	1.32 (1.04 to 1.67)	1.38 (1.09 to 1.74)	1.95 (1.64 to 2.32)
Anti-4	2.25 (1.97 to 2.57)	2.21 (1.95 to 2.51)	2.21 (1.96 to 2.5)	1.57 (1.21 to 2.04)	1.95 (1.63 to 2.32)	2.59 (2.07 to 3.24)
Anti-5	2.93 (2.58 to 3.33)	2.39 (2.13 to 2.69)	2.77 (2.44 to 3.15)	1.95 (1.53 to 2.48)	2.36 (1.89 to 2.94)	3.05 (2.53 to 3.68)
Anti-6B	0.67 (0.55 to 0.81)	0.76 (0.63 to 0.92)	0.6 (0.49 to 0.72)	0.49 (0.34 to 0.69)	0.42 (0.28 to 0.62)	0.72 (0.51 to 1.02)
Anti-7F	2.87 (2.52 to 3.27)	2.83 (2.52 to 3.17)	2.77 (2.49 to 3.09)	2.18 (1.75 to 2.7)	2.45 (2.01 to 2.99)	2.95 (2.37 to 3.69)
Anti-9V	2.1 (1.81 to 2.42)	2.01 (1.79 to 2.27)	2.18 (1.91 to 2.5)	1.67 (1.3 to 2.13)	1.82 (1.48 to 2.23)	2.4 (1.87 to 3.1)
Anti-14	4.76 (4.1 to 5.51)	4.52 (3.91 to 5.21)	4.77 (4.08 to 5.58)	3.44 (2.55 to 4.62)	4.12 (3.21 to 5.29)	5.17 (4.2 to 6.36)
Anti-18C	3.85 (3.23 to 4.6)	3.8 (3.24 to 4.46)	4.34 (3.65 to 5.15)	3.08 (2.29 to 4.15)	4.08 (3.15 to 5.29)	4.96 (3.75 to 6.55)

IIBU Group vs NIBU Group: GMC ratio: 0.96 (99.8% CI 0.71 to 1.29)
IIBU Group vs NIBU Group: GMC ratio: 1.02 (99.8% CI 0.77 to 1.35)
IIBU Group vs NIBU Group: GMC ratio: 1.06 (99.8% CI 0.8 to 1.41)

Primary outcome: Antibody Concentrations Against Protein D (Anti-PD)

Time frame: One month after primary immunization (At Month 3). Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	IIBU Group n = 150	DIBU Group n = 158	NIBU Group n = 164	IPARA Group n = 54	DPARA Group n = 53	NPARA Group n = 54
Value	1461.3 (1267.4 to 1684.8)	1353.1 (1191.3 to 1537)	1557.7 (1355.4 to 1790.3)	1109.6 (876.9 to 1404.1)	1348.6 (1048.2 to 1734.9)	1667.9 (1401.9 to 1984.4)

IIBU Group vs NIBU Group: GMC ratio: 0.94 (99.8% CI 0.69 to 1.28)
DIBU Group vs NIBU Group: GMC ratio: 0.87 (99.8% CI 0.64 to 1.17)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up periods after primary and booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) follow-up periods after primary and booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 10).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IIBU Group	4 of 198 (2%)	181 of 198 (91.4%)	0 of 198
DIBU Group	4 of 198 (2%)	171 of 198 (86.4%)	0 of 198
NIBU Group	2 of 199 (1%)	186 of 199 (93.5%)	0 of 199
IPARA Group	4 of 71 (5.6%)	60 of 71 (84.5%)	0 of 71
DPARA Group	1 of 72 (1.4%)	61 of 72 (84.7%)	0 of 72
NPARA Group	0 of 74 (0%)	73 of 74 (98.6%)	0 of 74
IIBU-IIBU Group	0 of 64 (0%)	44 of 64 (68.8%)	0 of 64
IIBU-DIBU Group	1 of 60 (1.7%)	41 of 60 (68.3%)	0 of 60
IIBU-NIBU Group	0 of 63 (0%)	34 of 63 (54%)	0 of 63
DIBU-IIBU Group	0 of 63 (0%)	43 of 63 (68.3%)	0 of 63
DIBU-DIBU Group	0 of 63 (0%)	41 of 63 (65.1%)	0 of 63
DIBU-NIBU Group	0 of 63 (0%)	42 of 63 (66.7%)	0 of 63
NIBU-IIBU Group	0 of 63 (0%)	50 of 63 (79.4%)	0 of 63
NIBU-DIBU Group	1 of 65 (1.5%)	51 of 65 (78.5%)	0 of 65
NIBU-NIBU Group	0 of 62 (0%)	45 of 62 (72.6%)	0 of 62
IPARA-NPARA Group	1 of 67 (1.5%)	43 of 67 (64.2%)	0 of 67
DPARA-IPARA Group	0 of 68 (0%)	45 of 68 (66.2%)	0 of 68
NPARA-IPARA Group	0 of 67 (0%)	45 of 67 (67.2%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27541270Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.
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.

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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

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GSK1024850A (SynflorixTM), Infanrix hexa and Infanrix-IPV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 23 sites in Romania.

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 19 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 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Romania. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 31 Jan 2019). 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?

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off (time frame: One month after primary immunization (At Month 3)). The study lists 3 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 NCT01235949, 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 10 May 2019.