TetanusPhase 2NCT00970307
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
A Phase 2 study testing GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A) and Infanrix hexa™ in people with Tetanus and Diphtheria, run by GlaxoSmithKline at 9 sites in Poland.
Trial summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age. Read more about this study
- Who is it for?
- Ages 8 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria, Haemophilus Influenzae Type b
- What is being tested?
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A) and Infanrix hexa™
- 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
- 421 participants
- Where
- 9 sitesPoland
- Study dates
- 13 Aug 2009to 27 Jan 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
- Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent/LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration 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.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
Show all 12Show fewer
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Poland9 sites
GSK Investigational Site
Bydgoszcz, 85-021
GSK Investigational Site
Dębica, 39-200
GSK Investigational Site
Krakow, 31-503
GSK Investigational Site
Krakow
GSK Investigational Site
Siemianowice Śląskie, 41-103
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Torun
GSK Investigational Site
Trzebnica, 55-100
GSK Investigational Site
Wroclaw, 50345
About this study
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Read the detailed description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Hepatitis B
- Being tested
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™, Menjugate®
- Medical subject headings
- Tetanus, Diphtheria, Haemophilus Infections, Poliomyelitis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2202083A vaccineBiological
Intramuscular, three doses
10-valent pneumococcal vaccine (GSK 1024850A)Biological
Intramuscular, three doses
Infanrix hexa™Biological
Intramuscular, three doses
Menjugate®Biological
Intramuscular, two doses
| Study group | Role | What they receive |
|---|---|---|
| GSK2202083A + SYNFLORIX GROUP | Experimental | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. Receives: Biological: GSK2202083A vaccine; Biological: 10-valent pneumococcal vaccine (GSK 1024850A) |
| INFANRIX HEXA + MENJUGATE GROUP | Active comparator | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. Receives: Biological: Infanrix hexa™; Biological: Menjugate® |
| INFANRIX HEXA + SYNFLORIX GROUP | Active comparator | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. Receives: Biological: 10-valent pneumococcal vaccine (GSK 1024850A); Biological: Infanrix hexa™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 3
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
Measured: At Month 3
Secondary outcomes (21)
Anti-PRP Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.
Measured: At Months 0 and 3
Antibody Titers Against rSBA-MenC
The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.
Measured: At Months 0 and 3
Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)
A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.
Measured: At Month 3
Anti-PSC Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.
Measured: At Months 0 and 3
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: At Month 3
Anti-D and Anti-T Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.
Measured: At Month 3
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Month 3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Measured: At Months 0 and 3
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.
Measured: At Month 3
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Measured: At Month 3
Anti-HBs Antibody Concentrations
Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.
Measured: At Month 3
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.
Measured: At Month 3
Anti-polio Types 1, 2 and 3 Antibody Titers
Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.
Measured: At Month 3
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: At Month 3
Anti-pneumo Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.
Measured: At Month 3
Number of Seropositive Subjects for Anti-protein D (Anti-PD)
A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.
Measured: At Month 3
Anti-PD Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.
Measured: At Month 3
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.
Measured: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day (Days 0-30) post-vaccination period after any vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: During 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 posted2 Sep 2009 (estimated)
- Study start13 Aug 2009
- Primary completion27 Jan 2010
- Study completion27 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TetanusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 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
- NCT00970307
- Sponsor's protocol ID
- 112157
- Other IDs
- 2009-010431-41, 2009
- Status last verified
- Dec 2019
- First submitted
- 27 Aug 2009
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.
PubMed 23838777
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
- ClinicalTrials.gov ID
- NCT00970307
- Acronym / sponsor ID
- 112157
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2009 (actual)
- Primary completion
- 27 Jan 2010 (actual)
- Study completion
- 27 Jan 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 14 Apr 2017
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 the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Detailed description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK2202083A + SYNFLORIX GROUP | Experimental | Biological: GSK2202083A vaccine, Biological: 10-valent pneumococcal vaccine (GSK 1024850A)Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| INFANRIX HEXA + MENJUGATE GROUP | Active comparator | Biological: Infanrix hexa™, Biological: Menjugate®Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| INFANRIX HEXA + SYNFLORIX GROUP | Active comparator | Biological: 10-valent pneumococcal vaccine (GSK 1024850A), Biological: Infanrix hexa™Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
- Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent/LAR of the subject.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration 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.
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 |
|---|---|---|
| GSK2202083A vaccineIntramuscular, three doses | Biological | GSK2202083A + SYNFLORIX GROUP |
| 10-valent pneumococcal vaccine (GSK 1024850A)Intramuscular, three doses | Biological | GSK2202083A + SYNFLORIX GROUP, INFANRIX HEXA + SYNFLORIX GROUP |
| Infanrix hexa™Intramuscular, three doses | Biological | INFANRIX HEXA + MENJUGATE GROUP, INFANRIX HEXA + SYNFLORIX GROUP |
| Menjugate®Intramuscular, two doses | Biological | INFANRIX HEXA + MENJUGATE GROUP |
Primary outcome
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
Time frame: At Month 3
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
Time frame: At Month 3
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
21 secondary outcomes
Anti-PRP Antibody Concentrations
Time frame: At Months 0 and 3
Antibody Titers Against rSBA-MenC
Time frame: At Months 0 and 3
Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)
Time frame: At Month 3
Anti-PSC Antibody Concentrations
Time frame: At Months 0 and 3
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
Time frame: At Month 3
Anti-D and Anti-T Antibody Concentrations
Time frame: At Month 3
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: At Month 3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: At Months 0 and 3
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Time frame: At Month 3
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
Time frame: At Month 3
Anti-HBs Antibody Concentrations
Time frame: At Month 3
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
Time frame: At Month 3
Anti-polio Types 1, 2 and 3 Antibody Titers
Time frame: At Month 3
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
Time frame: At Month 3
Anti-pneumo Antibody Concentrations
Time frame: At Month 3
Number of Seropositive Subjects for Anti-protein D (Anti-PD)
Time frame: At Month 3
Anti-PD Antibody Concentrations
Time frame: At Month 3
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period after any vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During 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 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23838777Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age. Pediatr Infect Dis J. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.
- 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. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A) and Infanrix hexa™ in people with Tetanus and Diphtheria, run by GlaxoSmithKline at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Apr 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?
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) (time frame: At Month 3). 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 NCT00970307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.