Neisseria MeningitidisPhase 2NCT00871338
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
A Phase 2 study testing GSK2197870A, Prevenar™ and Menitorix™ in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 5 sites in United Kingdom.
Trial summary
The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12… Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Haemophilus Influenzae Type b
- What is being tested?
- GSK2197870A, Prevenar™ and Menitorix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 24 Jun 2009to 9 Dec 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All subjects must satisfy the following criteria at study entry:
- A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after 36 to 42 weeks of gestation.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, 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 .
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- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
- History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- 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 and no other exclusion criteria are met:
- Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
GSK Investigational Site
Bristol, BS2 8AE
GSK Investigational Site
Ely, Cambridgeshire, CB7 4HF
GSK Investigational Site
London, SW17 0QT
GSK Investigational Site
Oxford, Oxfordshire, OX3 7LJ
GSK Investigational Site
Southampton, Hampshire, SO16 6YD
About this study
Official title: Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age
The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
Read the detailed description
This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.
- Being tested
- GSK2197870A, Prevenar™, Menitorix™, Pediacel™, Menjugate™
- Keywords
- combined, Vaccines
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2197870ABiological
Also called GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, polio
3 doses given at 2, 3 and 4 months of age
Prevenar™Biological
Also called Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
3 co-administered doses, intramuscular into right thigh
Menitorix™Biological
Also called GSK Biologicals' combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.
1 booster dose at 12 months of age
Pediacel™Biological
Also called Sanofi-Pasteur-MSD's combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.
3 doses given at 2, 3 and 4 months of age
Menjugate™Biological
Also called Novartis' meningococcal serogroup C CRM197 protein conjugated vaccine.
2 doses given at 3 and 4 months of age
| Study group | Role | What they receive |
|---|---|---|
| GSK2197870A Group | Experimental | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh. Receives: Biological: GSK2197870A; Biological: Prevenar™; Biological: Menitorix™ |
| Pediacel Group | Active comparator | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh. Receives: Biological: Prevenar™; Biological: Menitorix™; Biological: Pediacel™; Biological: Menjugate™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 3
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Measured: At Month 2 and Month 3.
Secondary outcomes (32)
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).
Measured: At Month 3
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Measured: At Month 2 and Month 3.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: At Month 3.
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
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 vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Measured: At Month 3.
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.
Measured: At Month 3
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Measured: At Month 3.
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Measured: At Month 2 and Month 3.
Concentrations for Anti-PSC.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Measured: At Month 2 and Month 3.
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.
Measured: At Month 3.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Measured: At Month 3.
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
Measured: At Month 3.
Concentrations for Anti-PNE Serotypes.
Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.
Measured: At Month 3.
Number of Seroprotected Subjects for Anti-PRP.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 10 and Month 11.
Number of Seropositive Subjects Against rSBA-MenC.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Measured: At Month 10 and Month 11.
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Measured: At Month 10 and Month 11.
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Measured: At Month 10.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Measured: At Month 10.
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Measured: At Month 10.
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Measured: At Month 10 and Month 11.
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Measured: At Month 10 and Month 11.
Concentrations for Anti-PSC.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Measured: At Month 10 and Month 11.
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Measured: At Month 10.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Measured: At Month 10.
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.
Measured: At Month 10.
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.
Measured: At Month 11
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Measured: At Month 11
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Measured: At Month 11
Number of Subjects Reporting Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE is 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow up period after vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Measured: During the entire study period (Month 0 to Month 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study start24 Jun 2009
- Primary completion31 Mar 2010
- Study completion9 Dec 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 Neisseria MeningitidisStudies 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
- 284 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
- NCT00871338
- Sponsor's protocol ID
- 111709
- Status last verified
- Sep 2016
- First submitted
- 26 Mar 2009
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Khatami A, Snape MD, Ohene-Kena B, Young K, Oeser C, Michaelis LJ, Macleod E, Smee H, Van Der Meeren O, Leyssen M, Caubet M, Yu LM, Heath PT, Faust SN, Finn A, Pollard AJ. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Pediatr Infect Dis J. 2013 Jun;32(6):675-81. doi: 10.1097/INF.0b013e31828672a7.
PubMed 23348809
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age
- ClinicalTrials.gov ID
- NCT00871338
- Acronym / sponsor ID
- 111709
- Keywords
- combined, Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2009
- Primary completion
- 31 Mar 2010 (actual)
- Study completion
- 9 Dec 2010 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 28 Jul 2014
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 Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
Detailed description
This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2197870A Group | Experimental | Biological: GSK2197870A, Biological: Prevenar™, Biological: Menitorix™Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh. |
| Pediacel Group | Active comparator | Biological: Prevenar™, Biological: Menitorix™, Biological: Pediacel™, Biological: Menjugate™Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after 36 to 42 weeks of gestation.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (13 listed)
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
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 |
|---|---|---|
| GSK2197870AAlso: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, polio3 doses given at 2, 3 and 4 months of age | Biological | GSK2197870A Group |
| Prevenar™Also: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine3 co-administered doses, intramuscular into right thigh | Biological | GSK2197870A Group, Pediacel Group |
| Menitorix™Also: GSK Biologicals' combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.1 booster dose at 12 months of age | Biological | GSK2197870A Group, Pediacel Group |
| Pediacel™Also: Sanofi-Pasteur-MSD's combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.3 doses given at 2, 3 and 4 months of age | Biological | Pediacel Group |
| Menjugate™Also: Novartis' meningococcal serogroup C CRM197 protein conjugated vaccine.2 doses given at 3 and 4 months of age | Biological | Pediacel Group |
Primary outcome
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
Time frame: At Month 3
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
Time frame: At Month 2 and Month 3.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
32 secondary outcomes
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
Time frame: At Month 3
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
Time frame: At Month 2 and Month 3.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 3.
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
Time frame: At Month 3.
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Time frame: At Month 3.
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Time frame: At Month 3
Concentrations for Anti-PRP.
Time frame: At Month 3.
Titers for rSBA-MenC.
Time frame: At Month 2 and Month 3.
Concentrations for Anti-PSC.
Time frame: At Month 2 and Month 3.
Concentrations for Anti-T and Anti-D.
Time frame: At Month 3.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 3.
Titers for Anti-polio 1, 2 and 3.
Time frame: At Month 3.
Concentrations for Anti-PNE Serotypes.
Time frame: At Month 3.
Number of Seroprotected Subjects for Anti-PRP.
Time frame: At Month 10 and Month 11.
Number of Seropositive Subjects Against rSBA-MenC.
Time frame: At Month 10 and Month 11.
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
Time frame: At Month 10 and Month 11.
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
Time frame: At Month 10.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 10.
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
Time frame: At Month 10.
Concentrations for Anti-PRP.
Time frame: At Month 10 and Month 11.
Titers for rSBA-MenC.
Time frame: At Month 10 and Month 11.
Concentrations for Anti-PSC.
Time frame: At Month 10 and Month 11.
Concentrations for Anti-T and Anti-D.
Time frame: At Month 10.
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 10.
Titers for Anti-polio 1, 2 and 3.
Time frame: At Month 10.
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
Time frame: At Month 11
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
Time frame: At Month 11
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
Time frame: At Month 11
Number of Subjects Reporting Any Solicited Local Symptoms.
Time frame: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Solicited General Symptoms.
Time frame: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Time frame: During the entire study period (Month 0 to Month 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23348809Khatami A, Snape MD, Ohene-Kena B, Young K, Oeser C, Michaelis LJ, Macleod E, Smee H, Van Der Meeren O, Leyssen M, Caubet M, Yu LM, Heath PT, Faust SN, Finn A, Pollard AJ. Phase II study of a three-dose primary vaccination course of DTPa-IPV/Hib-MenC-TT followed by a 12-month Hib-MenC-TT booster in healthy infants. Pediatr Infect Dis J. 2013 Jun;32(6):675-81. doi: 10.1097/INF.0b013e31828672a7.
- 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
5 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 GSK2197870A, Prevenar™ and Menitorix™ in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 5 sites in United Kingdom.
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 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 28 Jul 2014). 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 for Anti-polyribosylribitol Phosphate (Anti-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 NCT00871338, 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 6 Jun 2018.