Infections, StreptococcalPhase 3NCT00678301
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
A Phase 3 study testing GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™ and GSK Biologicals' Zilbrix™ Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered… Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™ and GSK Biologicals' Zilbrix™ 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
- 365 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Jun 2008to 10 Dec 2009
- 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 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
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 the study vaccines, 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
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- Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
- History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
- Babies for which birth weight is < 2 kilogram (if known) at Visit 1
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Read the detailed description
Vaccination course at 6, 10, 14 weeks of age.
- Conditions
- Infections, Streptococcal
- Being tested
- GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™, GSK Biologicals' Zilbrix™ Hib
- Keywords
- pneumococcal conjugate vaccine, Streptococcus pneumoniae
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' Synflorix™Biological
Also called 10Pn
3 IM doses.
GSK Biologicals' Polio Sabin™Biological
Also called OPV
3 oral doses
GSK Biologicals' Zilbrix™ HibBiological
Also called DTPw-HBV/Hib vaccine
3 IM doses.
| Study group | Role | What they receive |
|---|---|---|
| SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™ | Experimental | Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally. Receives: Biological: GSK Biologicals' Synflorix™; Biological: GSK Biologicals' Polio Sabin™; Biological: GSK Biologicals' Zilbrix™ Hib |
| ZILBRIX™ HIB + POLIO SABIN™ | Experimental | Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally. Receives: Biological: GSK Biologicals' Polio Sabin™; Biological: GSK Biologicals' Zilbrix™ Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Antibody Concentrations Against Protein D (Anti-PD Antibodies)
Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Secondary outcomes (24)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes
Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.05 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations ≥ 0.2 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) ≥ 0.05 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19 A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations ≥ 0.2 microgram per milliliter (μg/mL).
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)
Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 8.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) ≥ 8.
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
Anti-BPT antibody concentrations were expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations ≥ 15 EL.U/mL
Measured: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)
Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).
Measured: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
The seroprotection cut-off for the assay was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international unit per milliliter (IU/mL).
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens
A subject seroprotected against D/TT antigens was defined as a subject with an Anti-D/-TT antibody concentration ≥ 0.1 IU/mL.
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Anti-PRP antibody concentrations were measured and tabulated in microgram per milliliter (μg/mL). Cut-off for the assay was ≥ 0.15 μg/mL.
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)
Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 0.15 μg/mL.
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens
Anti-PRP antibody concentrations were expressed in microgram per milliliter (μg/mL). The seroprotection cut-off applied for the assay was ≥ 1 μg/mL.
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
The seroprotection cut-off for the endpoint was an anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Measured: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine
Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).
The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration ≥ 10 and 100 milli-international units per milliliter (mIU/mL).
Measured: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine
Number of Subjects With Any and Any 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 the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of Subjects With Any and 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. "Any" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 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.
Measured: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off
The cut-off for the assay was > 39.0°C.
Measured: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines
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: Throughout the entire study period, from Month 0 to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study start18 Jun 2008
- Primary completion9 Nov 2009
- Study completion10 Dec 2009
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
- None (open label)
- Enrolment
- 365 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
- NCT00678301
- Sponsor's protocol ID
- 110521
- Other IDs
- 2011-004650-25
- Status last verified
- Oct 2019
- First submitted
- 13 May 2008
- Last updated
- 15 Nov 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
Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, Diallo A, Kuyinu YA, Kehinde OA, Francois N, Borys D, Yarzabal JP, Moreira M, Schuerman L. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.
PubMed 22112189Odusanya OO, Kuyinu YA, Kehinde OA, Francois N, Yarzabal JP, Moreira M, Borys D, Schuerman L. Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial. Niger Postgrad Med J. 2013 Dec;20(4):272-81.
PubMed 24633268Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
PubMed 26954689
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™
- ClinicalTrials.gov ID
- NCT00678301
- Acronym / sponsor ID
- 110521
- Conditions
- Infections, Streptococcal
- Keywords
- pneumococcal conjugate vaccine, Streptococcus pneumoniae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2008 (actual)
- Primary completion
- 9 Nov 2009 (actual)
- Study completion
- 10 Dec 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 27 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.
Detailed description
Vaccination course at 6, 10, 14 weeks of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™ | Experimental | Biological: GSK Biologicals' Synflorix™, Biological: GSK Biologicals' Polio Sabin™, Biological: GSK Biologicals' Zilbrix™ HibSubjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally. |
| ZILBRIX™ HIB + POLIO SABIN™ | Experimental | Biological: GSK Biologicals' Polio Sabin™, Biological: GSK Biologicals' Zilbrix™ HibSubjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
Key exclusion criteria (13 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 the study vaccines, 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
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 |
|---|---|---|
| GSK Biologicals' Synflorix™Also: 10Pn3 IM doses. | Biological | SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™ |
| GSK Biologicals' Polio Sabin™Also: OPV3 oral doses | Biological | SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™, ZILBRIX™ HIB + POLIO SABIN™ |
| GSK Biologicals' Zilbrix™ HibAlso: DTPw-HBV/Hib vaccine3 IM doses. | Biological | SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™, ZILBRIX™ HIB + POLIO SABIN™ |
Primary outcome
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).
Antibody Concentrations Against Protein D (Anti-PD Antibodies)
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.
24 secondary outcomes
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
Time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)
Time frame: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine
Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).
Time frame: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine
Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
Time frame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms
Time frame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off
Time frame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the entire study period, from Month 0 to Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22112189Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, Diallo A, Kuyinu YA, Kehinde OA, Francois N, Borys D, Yarzabal JP, Moreira M, Schuerman L. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.
- Background: PubMed 24633268Odusanya OO, Kuyinu YA, Kehinde OA, Francois N, Yarzabal JP, Moreira M, Borys D, Schuerman L. Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial. Niger Postgrad Med J. 2013 Dec;20(4):272-81.
- Background: PubMed 26954689Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
- 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
2 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 GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™ and GSK Biologicals' Zilbrix™ Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 2 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 4 inclusion and 13 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali, Nigeria. 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 27 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (time frame: At Month 3, one month after the administration of the third dose of Synflorix vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678301, 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 15 Nov 2019.