- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871338
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bristol, United Kingdom, BS2 8AE
- GSK Investigational Site
-
London, United Kingdom, SW17 0QT
- GSK Investigational Site
-
-
Cambridgeshire
-
Ely, Cambridgeshire, United Kingdom, CB7 4HF
- GSK Investigational Site
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 6YD
- GSK Investigational Site
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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 .
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GSK2197870A Group
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.
|
3 doses given at 2, 3 and 4 months of age
Other Names:
3 co-administered doses, intramuscular into right thigh
Other Names:
1 booster dose at 12 months of age
Other Names:
|
ACTIVE_COMPARATOR: Pediacel Group
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.
|
3 co-administered doses, intramuscular into right thigh
Other Names:
1 booster dose at 12 months of age
Other Names:
3 doses given at 2, 3 and 4 months of age
Other Names:
2 doses given at 3 and 4 months of age
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At Month 3
|
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.
|
At Month 2 and Month 3.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
Time Frame: At Month 3
|
The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).
|
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.
|
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
|
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.
|
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).
|
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.
|
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).
|
At Month 3.
|
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Time Frame: At Month 3.
|
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
|
At Month 3.
|
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Time Frame: At Month 3
|
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.
|
At Month 3
|
Concentrations for Anti-PRP.
Time Frame: At Month 3.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
|
At Month 3.
|
Titers for rSBA-MenC.
Time Frame: At Month 2 and Month 3.
|
Titers were expressed as geometric mean titers (GMCs).
The seropositivity reference cut-off value was ≥ 1:8.
|
At Month 2 and Month 3.
|
Concentrations for Anti-PSC.
Time Frame: At Month 2 and Month 3.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
|
At Month 2 and Month 3.
|
Concentrations for Anti-T and Anti-D.
Time Frame: At Month 3.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seroprotection reference cut-off value was ≥ 0.1 IU/mL.
|
At Month 3.
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time Frame: At Month 3.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
|
At Month 3.
|
Titers for Anti-polio 1, 2 and 3.
Time Frame: At Month 3.
|
Titers were expressed as geometric mean titers (GMTs).
The seropositivity reference cut-off value was ≥ 1:8.
|
At Month 3.
|
Concentrations for Anti-PNE Serotypes.
Time Frame: At Month 3.
|
Concentrations were expressed as geometric mean concentreations (GMCs).
The seropositivity reference cut-off value was ≥ 0.2 µg/mL.
|
At Month 3.
|
Number of Seroprotected Subjects for Anti-PRP.
Time Frame: At Month 10 and Month 11.
|
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
|
At Month 10 and Month 11.
|
Number of Seropositive Subjects Against rSBA-MenC.
Time Frame: At Month 10 and Month 11.
|
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
|
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.
|
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
|
At Month 10 and Month 11.
|
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
Time Frame: At Month 10.
|
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).
|
At Month 10.
|
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Time Frame: At Month 10.
|
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).
|
At Month 10.
|
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
Time Frame: At Month 10.
|
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
|
At Month 10.
|
Concentrations for Anti-PRP.
Time Frame: At Month 10 and Month 11.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
|
At Month 10 and Month 11.
|
Titers for rSBA-MenC.
Time Frame: At Month 10 and Month 11.
|
Titers were expressed as geometric mean titers (GMCs).
The seropositivity reference cut-off value was ≥ 1:8.
|
At Month 10 and Month 11.
|
Concentrations for Anti-PSC.
Time Frame: At Month 10 and Month 11.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
|
At Month 10 and Month 11.
|
Concentrations for Anti-T and Anti-D.
Time Frame: At Month 10.
|
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).
|
At Month 10.
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Time Frame: At Month 10.
|
Concentrations were expressed as geometric mean concentrations (GMCs).
The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
|
At Month 10.
|
Titers for Anti-polio 1, 2 and 3.
Time Frame: At Month 10.
|
Titers were expressed as geometric mean titers (GMTs).
The seroprotection reference cut-off value was ≥ 1:8.
|
At Month 10.
|
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
Time Frame: At Month 11
|
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.
|
At Month 11
|
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
Time Frame: At Month 11
|
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.
|
At Month 11
|
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
Time Frame: At Month 11
|
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.
|
At Month 11
|
Number of Subjects Reporting Any Solicited Local Symptoms.
Time Frame: During the 8-day (Days 0-7)
|
Solicited local symptoms assessed were pain, redness and swelling.
Any = occurrence of any local symptom regardless of intensity grade.
|
During the 8-day (Days 0-7)
|
Number of Subjects Reporting Any Solicited General Symptoms.
Time Frame: During the 8-day (Days 0-7)
|
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.
|
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.
|
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.
|
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)
|
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.
|
During the entire study period (Month 0 to Month 11)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Individual Participant Data Set
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 111709Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neisseria Meningitidis
-
Public Health EnglandCompleted
-
University Hospital, RouenInstitut Pasteur; Direction Générale de la Santé, FranceCompleted
-
Public Health EnglandCompletedNeisseria Meningitidis Serogroup BUnited Kingdom
-
University of AdelaideCompletedNeisseria MeningitidisAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bAustralia
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bUnited States
-
GlaxoSmithKlineCompletedNeisseria Meningitidis | Haemophilus Influenzae Type bSpain