Infections, StreptococcalPhase 3NCT00344318
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Prevenar and Tritanrix-HepB in people with Infections, Streptococcal, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age. The study has 2 groups. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal conjugate vaccine GSK1024850A, Prevenar and Tritanrix-HepB
- 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
- 806 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 7 Aug 2006to 17 Oct 2007
- 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent or guardian 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 between 36 and 42 weeks.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. 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, and Haemophilus influenzae type b diseases.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Show all 12Show fewer
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
- Acute disease at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical
- 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 the active phase of the study.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Poland6 sites
GSK Investigational Site
Gdansk, 80-394
GSK Investigational Site
Lodz, 91-347
GSK Investigational Site
Trzebnica, 55-100
GSK Investigational Site
Tuchola, 89-500
GSK Investigational Site
Wroclaw, 50345
GSK Investigational Site
Wroclaw, 52-312
About this study
Official title: To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.
The study has 2 groups.
Read more
- One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
- The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.
All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. 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 =00547248).
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, Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin.
- Keywords
- Immunogenicity, Safety, Pneumococcal vaccine, Pneumococcal disease
- Medical subject headings
- Streptococcal Infections, 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
3 Intramuscular injections.
PrevenarBiological
3 Intramuscular injections
Tritanrix-HepBBiological
Also called DTPw-HBV
3 Intramuscular injections
HiberixBiological
Also called Hib
Reconstituted with Tritanrix before injection
Polio Sabin.Biological
Also called OPV
3 oral doses.
Poliorix.Biological
Also called IPV
3 intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Synflorix 1 Group | Experimental | Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin.; Biological: Poliorix. |
| Synflorix 2 Group | Experimental | Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin.; Biological: Poliorix. |
| Prevenar 1 Group | Active comparator | Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. Receives: Biological: Prevenar; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin.; Biological: Poliorix. |
| Prevenar 2 Group | Active comparator | Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age. Receives: Biological: Prevenar; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin.; Biological: Poliorix. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
Measured: Within 4 day (Days 0-3) after each dose and across doses
Secondary outcomes (28)
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Measured: Within 4 day (Days 0-3) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Related (REL) = Symptom assessed by the investigator as causally related to vaccination.
Measured: Within 4-day (Days 0-3) after each dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: Within 31 days (Days 0-30) after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group
Number of Subjects With Serious Adverse (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group
Concentrations of Antibodies Against 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 administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)
Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)
Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic Activity (OPA) 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 administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8
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 administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)
Cut-off values assessed were greater than or equal to 0.05 microgram per milliliter (μg/mL) in the sera of subjects seronegative before vaccination.
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of Antibodies Against Protein D (Anti-PD)
Seropositivity status, defined as Anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL)
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)
Cut-off values assessed were greater than or equal to 100 ELISA units per milliliter (EL.U/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)
Cut-off values assessed were greater than or equal to 0.15 microgram per milliliter (µg/ mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
Cut-off values assessed were greater than or equal to 1.0 microgram per milliliter (µg/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Seroprotection status, defined as Anti-PRP antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Cut-off values assessed were greater than or equal to 0.1 International Units per milliliter (IU/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Seroprotection status, defined as Anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)
Cut-off values assessed were greater than or equal to 10 milli-International Units per milliliter (mIU/mL) in the sera of subjects.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status, defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8
Titers were expressed as geometric mean titres (GMTs).
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
Seroprotection status, defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)
Cut-off values assessed were greater than or equal to 15 ELISA unit per milli-liter (EL.U/mL) in the sera of subjects seronegative before vaccination.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
Seropositivity status, defined as Anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Vaccine Response to Bordetella Pertussis
Vaccine response to B. pertussis;defined as appearance of antibodies in subjects initially seronegative (S-) (i.e., concentrations < 15 EL.U/mL) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e., with concentrations ≥ 15 EL.U/mL).
Measured: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start7 Aug 2006
- Primary completion27 Apr 2007
- Study completion17 Oct 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 806 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
- NCT00344318
- Sponsor's protocol ID
- 107007
- Status last verified
- May 2018
- First submitted
- 23 Jun 2006
- Last updated
- 7 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
Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.
PubMed 19325452Bermal N, Szenborn L, Chrobot A, Alberto E, Lommel P, Gatchalian S, Dieussaert I, Schuerman L. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S89-96. doi: 10.1097/INF.0b013e318199f901.
PubMed 19325451Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.
PubMed 19325447
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
- ClinicalTrials.gov ID
- NCT00344318
- Acronym / sponsor ID
- 107007
- Conditions
- Infections, Streptococcal
- Keywords
- Immunogenicity, Safety, Pneumococcal vaccine, Pneumococcal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2006 (actual)
- Primary completion
- 27 Apr 2007 (actual)
- Study completion
- 17 Oct 2007 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Posted 7 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 will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.
The study has 2 groups.
- One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
- The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.
All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. 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 =00547248).
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Synflorix 1 Group | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio Sabin., Biological: Poliorix.Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. |
| Synflorix 2 Group | Experimental | Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio Sabin., Biological: Poliorix.Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. |
| Prevenar 1 Group | Active comparator | Biological: Prevenar, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio Sabin., Biological: Poliorix.Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. |
| Prevenar 2 Group | Active comparator | Biological: Prevenar, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio Sabin., Biological: Poliorix.Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent or guardian 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 between 36 and 42 weeks.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. 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, and Haemophilus influenzae type b diseases.
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 GSK1024850A3 Intramuscular injections. | Biological | Synflorix 1 Group, Synflorix 2 Group |
| Prevenar3 Intramuscular injections | Biological | Prevenar 1 Group, Prevenar 2 Group |
| Tritanrix-HepBAlso: DTPw-HBV3 Intramuscular injections | Biological | Prevenar 1 Group, Prevenar 2 Group, Synflorix 1 Group, Synflorix 2 Group |
| HiberixAlso: HibReconstituted with Tritanrix before injection | Biological | Prevenar 1 Group, Prevenar 2 Group, Synflorix 1 Group, Synflorix 2 Group |
| Polio Sabin.Also: OPV3 oral doses. | Biological | Prevenar 1 Group, Prevenar 2 Group, Synflorix 1 Group, Synflorix 2 Group |
| Poliorix.Also: IPV3 intramuscular injections | Biological | Prevenar 1 Group, Prevenar 2 Group, Synflorix 1 Group, Synflorix 2 Group |
Primary outcome
Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)
Time frame: Within 4 day (Days 0-3) after each dose and across doses
Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
28 secondary outcomes
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
Time frame: Within 4 day (Days 0-3) after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within 4-day (Days 0-3) after each dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Days 0-30) after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group
Number of Subjects With Serious Adverse (SAEs)
Time frame: During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Concentrations of Antibodies Against Protein D (Anti-PD)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL)
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL)
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity)
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Number of Subjects With Vaccine Response to Bordetella Pertussis
Time frame: One month after the administration of the 3rd vaccine dose of Tritanrix™-HepB/Hiberix™ + Polio Sabin™ or Poliorix™
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19325452Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.
- Derived from this study: PubMed 19325451Bermal N, Szenborn L, Chrobot A, Alberto E, Lommel P, Gatchalian S, Dieussaert I, Schuerman L. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S89-96. doi: 10.1097/INF.0b013e318199f901.
- Derived from this study: PubMed 19325447Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.
- 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
7 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, Prevenar and Tritanrix-HepB in people with Infections, Streptococcal, run by GlaxoSmithKline at 7 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 5 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 7 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 7 sites in Poland, Philippines. 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 7 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 Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) (time frame: Within 4 day (Days 0-3) after each dose and across doses). 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 NCT00344318, 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 7 Dec 2018.