Infections, StreptococcalPhase 3NCT00390910
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A and Infanrix hexa in people with Infections, Streptococcal, run by GlaxoSmithKline at 8 sites in 2 countries.
Trial summary
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine… Read more about this study
- Who is it for?
- Ages 8 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal conjugate vaccine GSK1024850A and Infanrix hexa
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Oct 2006to 2 May 2008
- 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 8 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a gestation period of >27 weeks (at least 189 days).
- If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
- If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
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- History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past).
- Acute disease at the time of enrolment.
- 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, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month preceding the first dose of study vaccines or planned administration during the active phase of the study.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Greece5 sites
GSK Investigational Site
Athens, 115 27
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Ioannina, 452 21
GSK Investigational Site
Rio/Patras, 26500
GSK Investigational Site
Thessaloniki, 54636
Spain3 sites
GSK Investigational Site
Burgos, 09005
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Móstoles/Madrid, 28935
About this study
Official title: Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
Read the detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Keywords
- Pneumococcal vaccine, Preterm, Safety, Pneumococcal disease, Immunogenicity
- Medical subject headings
- Streptococcal Infections, Premature Birth, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection, 3 doses
Infanrix hexaBiological
Also called DTPa-HBV-IPV/Hib
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Synflorix™ + Infanrix™ hexa Group I | Experimental | Very preterm infants born after a gestation period of 27-30 weeks (189-216 days) Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa |
| Synflorix™ + Infanrix™ hexa Group II | Experimental | Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days) Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa |
| Synflorix™ + Infanrix™ hexa Group III | Experimental | Infants born after a gestation period of more than 36 weeks (more than 258 days) Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Measured: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Secondary outcomes (28)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included 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 greater than (>) 30 millimeters (mm). "Any" was defined as incidence of the specified symptom regardless of intensity.
Measured: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed included drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/ preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Measured: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any 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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
Number of Subjects With Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.
Measured: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
The cut-off for the assay was ≥ 8
Measured: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8.
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was ≥ 8.
Measured: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off
The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Protein D (Anti-PD)
Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off
Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off
Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.
The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).
Measured: One month after the 3rd vaccine dose (Month 5)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
The cut-off for the assay was ≥ 8.
Measured: One month after the 3rd vaccine dose (Month 5)
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.
Measured: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.
Measured: One month after the 3rd vaccine dose (Month 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study start1 Oct 2006
- Primary completion2 Jul 2007
- Study completion2 May 2008
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 (3)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 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
- NCT00390910
- Sponsor's protocol ID
- 107737
- Status last verified
- May 2017
- First submitted
- 20 Oct 2006
- Last updated
- 17 Dec 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
Omenaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, Francois N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. doi: 10.1542/peds.2010-1184. Epub 2011 Jul 4.
PubMed 21727108Omeneca F et al. Vaccination of pre-term infants with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Omeneca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.
- ClinicalTrials.gov ID
- NCT00390910
- Acronym / sponsor ID
- 107737
- Conditions
- Infections, Streptococcal
- Keywords
- Pneumococcal vaccine, Preterm, Safety, Pneumococcal disease, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 2 Jul 2007 (actual)
- Study completion
- 2 May 2008 (actual)
- First posted
- 23 Oct 2006 (estimated)
- Results
- Posted 17 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synflorix™ + Infanrix™ hexa Group I | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Infanrix hexaVery preterm infants born after a gestation period of 27-30 weeks (189-216 days) |
| Synflorix™ + Infanrix™ hexa Group II | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Infanrix hexaMild pretem infants born after a gestation period of 31-36 weeks (217-258 days) |
| Synflorix™ + Infanrix™ hexa Group III | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Infanrix hexaInfants born after a gestation period of more than 36 weeks (more than 258 days) |
Who may qualify
- Ages
- 8 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a gestation period of >27 weeks (at least 189 days).
- If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
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 conjugate vaccine GSK1024850AIntramuscular injection, 3 doses | Biological | Synflorix™ + Infanrix™ hexa Group I, Synflorix™ + Infanrix™ hexa Group II, Synflorix™ + Infanrix™ hexa Group III |
| Infanrix hexaAlso: DTPa-HBV-IPV/HibIntramuscular injection, 3 doses | Biological | Synflorix™ + Infanrix™ hexa Group I, Synflorix™ + Infanrix™ hexa Group II, Synflorix™ + Infanrix™ hexa Group III |
Primary outcome
Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
28 secondary outcomes
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Concentrations of Antibodies Against Protein D (Anti-PD)
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.
Time frame: One month after the 3rd vaccine dose (Month 5)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres
Time frame: One month after the 3rd vaccine dose (Month 5)
Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off
Time frame: One month after the 3rd vaccine dose (Month 5)
Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: One month after the 3rd vaccine dose (Month 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21727108Omenaca F, Merino JM, Tejedor JC, Constantopoulos A, Papaevangelou V, Kafetzis D, Tsirka A, Athanassiadou F, Anagnostakou M, Francois N, Borys D, Schuerman L. Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. Pediatrics. 2011 Aug;128(2):e290-8. doi: 10.1542/peds.2010-1184. Epub 2011 Jul 4.
- BackgroundOmeneca F et al. Vaccination of pre-term infants with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHID-CV). Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
- BackgroundOmeneca F et al. Immunogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) following primary and booster vaccination in preterm-born children. Abstract presented at Excellence In Paediatrics. Florence, Italy, 3-6 December 2009.
- 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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A and Infanrix hexa in people with Infections, Streptococcal, run by GlaxoSmithKline at 8 sites in 2 countries.
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 6 inclusion and 12 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece, Spain. 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 17 Dec 2018). 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 Core Fever (Rectal Temperature) Greater Than (>) the Cut-off (time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)). 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 NCT00390910, which also lists 3 linked publications.
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 17 Dec 2018.