Infections, StreptococcalPhase 3NCT00547248
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
A Phase 3 study testing Synflorix, Tritanrix-HepB and Hiberix in people with Infections, Streptococcal, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines… Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Synflorix, Tritanrix-HepB and Hiberix
- 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
- 756 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Oct 2007to 7 Oct 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
- 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.
Who cannot join
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
- Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
- History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
Show all 13Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- 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 and/or any blood products within three months preceding the booster dose of study vaccines 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: Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
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
- Synflorix, Tritanrix-HepB, Hiberix, Polio Sabin, Poliorix
- Keywords
- Booster vaccination., Immunogenicity, Pneumococcal vaccine, Safety, 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.
SynflorixBiological
Also called Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose
Tritanrix-HepBBiological
Also called DTPw-HBV vaccine
Intramuscular injection, 1 dose
HiberixBiological
Also called Hib vaccine
Reconstituted with Tritanrix-Hep B before injection
Polio SabinBiological
Also called OPV
Oral, 1 dose
PoliorixBiological
Also called IPV
Intramuscular injection, 1 dose
Prevenar (Wyeth)Biological
Also called Pneumococcal conjugate vaccine
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Experimental | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age. Receives: Biological: Synflorix; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin |
| Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Active comparator | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age. Receives: Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Polio Sabin; Biological: Prevenar (Wyeth) |
| Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | Experimental | Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age. Receives: Biological: Synflorix; Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Poliorix |
| Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group | Active comparator | Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age. Receives: Biological: Tritanrix-HepB; Biological: Hiberix; Biological: Poliorix; Biological: Prevenar (Wyeth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
Measured: Within the 4-day (Days 0-3) period after booster vaccination
Secondary outcomes (27)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. "Any" was defined as incidence of the specified symptom regardless of intensity. 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).
Measured: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature greater than or equal to (≥) 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) >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 0-3) period after booster vaccination
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) period after booster 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: Throughout the active phase of the study (Month 0 to Month 1)
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
The cut-off was 0.20 microgram per milliliter (μg/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations
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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Opsonophagocytic Activity (OPA) Titers Against 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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Antibody Concentrations to Protein D (Anti-PD)
Seropositivity status, defined as anti-PD antibody concentrations ≥100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Antibody Concentrations Against Pneumococcal Cross-reactive 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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
The cut-off of the assay was 0.05 μg/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against 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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
The cut-of for the assay was 0.05 μg/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off
The cut-off for the assay was 8.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off
The cut-off for the assay was 100 ELISA units per milliliter (EL.U/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-Bordetella Pertussis (BPT) Antibody Concentrations
Seropositivity status, defined as anti-BPT antibody concentrations ≥ 15 EL.U/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Seroprotection status, defined as anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-polio Type 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: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off
The cut-off for the assay was 15 EL.U/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
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 milli-international units per milliliter (mIU/mL).
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
The cut-off for the assay was 0.15 μg/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off
The cut-off for the assay was 1.0 μg/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off
The cut-off for the assay was 10 mIU/mL.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off
The cut-off for the assay was 8.
Measured: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)
Vaccine response for anti-BPT, defined as the appearance of antibodies in subjects seronegative at pre-vaccination, or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination.
Measured: One month after booster vaccination (Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study start22 Oct 2007
- Primary completion10 May 2008
- Study completion7 Oct 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 (5)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
- 756 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
- NCT00547248
- Sponsor's protocol ID
- 109509
- Status last verified
- May 2017
- First submitted
- 19 Oct 2007
- Last updated
- 14 Jan 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
Bermal N, Szenborn L, Edison A, Hernandez M, Pejcz J, Majda-Stanislawska E, Gatchalian S, Fanic A, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines. Pediatr Infect Dis J. 2011 Jan;30(1):69-72. doi: 10.1097/INF.0b013e3181f2da06.
PubMed 20980933Bermal N et al. Primary and booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib and polio vaccines. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Nancy B et al. Booster dose of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) administered to children in the Philippines: antibody responses and safety. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Immune responses to the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) appear not influenced by co-administration with DTPw-combination vaccine. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Booster Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in Children Who Completed the Primary Vaccination Course in Study 107007
- ClinicalTrials.gov ID
- NCT00547248
- Acronym / sponsor ID
- 109509
- Conditions
- Infections, Streptococcal
- Keywords
- Booster vaccination., Immunogenicity, Pneumococcal vaccine, Safety, Pneumococcal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2007 (actual)
- Primary completion
- 10 May 2008 (actual)
- Study completion
- 7 Oct 2008 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 14 Jan 2019
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 observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00344318)
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 + Tritanrix -HepB/ Hiberix + Polio Sabin Group | Experimental | Biological: Synflorix, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio SabinSubjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age. |
| Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | Active comparator | Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Polio Sabin, Biological: Prevenar (Wyeth)Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age. |
| Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | Experimental | Biological: Synflorix, Biological: Tritanrix-HepB, Biological: Hiberix, Biological: PoliorixSubjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age. |
| Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group | Active comparator | Biological: Tritanrix-HepB, Biological: Hiberix, Biological: Poliorix, Biological: Prevenar (Wyeth)Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age. |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
- 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.
Key exclusion criteria (13 listed)
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
- Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
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 |
|---|---|---|
| SynflorixAlso: Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection, 1 dose | Biological | Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group, Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
| Tritanrix-HepBAlso: DTPw-HBV vaccineIntramuscular injection, 1 dose | Biological | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group, Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group, Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group, Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
| HiberixAlso: Hib vaccineReconstituted with Tritanrix-Hep B before injection | Biological | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group, Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group, Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group, Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
| Polio SabinAlso: OPVOral, 1 dose | Biological | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group, Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group |
| PoliorixAlso: IPVIntramuscular injection, 1 dose | Biological | Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group, Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group |
| Prevenar (Wyeth)Also: Pneumococcal conjugate vaccineIntramuscular injection, 1 dose | Biological | Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group, Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group |
Primary outcome
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever > 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
27 secondary outcomes
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any and Grade 3 Solicited General Symptoms
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the active phase of the study (Month 0 to Month 1)
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Antibody Concentrations to Protein D (Anti-PD)
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-Bordetella Pertussis (BPT) Antibody Concentrations
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off
Time frame: Prior to (Month 0) and one month after booster vaccination (Month 1)
Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT)
Time frame: One month after booster vaccination (Month 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20980933Bermal N, Szenborn L, Edison A, Hernandez M, Pejcz J, Majda-Stanislawska E, Gatchalian S, Fanic A, Dieussaert I, Schuerman L. Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines. Pediatr Infect Dis J. 2011 Jan;30(1):69-72. doi: 10.1097/INF.0b013e3181f2da06.
- BackgroundBermal N et al. Primary and booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib and polio vaccines. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
- BackgroundNancy B et al. Booster dose of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) administered to children in the Philippines: antibody responses and safety. Abstract presented at the 13th Asian Pacific Congress of Pediatrics (APCP). Shanghai, China, 14-18 October 2009.
- BackgroundSchuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
- BackgroundSchuerman L et al. Immune responses to the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) appear not influenced by co-administration with DTPw-combination vaccine. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
- 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 Synflorix, Tritanrix-HepB and Hiberix 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 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 14 Jan 2019. 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 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off (time frame: Within the 4-day (Days 0-3) period after booster vaccination). 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 NCT00547248, which also lists 5 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 14 Jan 2019.