Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
1 other identifier
interventional
480
3 countries
34
Brief Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedStudy Start
First participant enrolled
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2011
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedAugust 20, 2018
August 1, 2016
1.4 years
March 18, 2010
June 19, 2014
June 28, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
At Month 3
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
At Month 3
Secondary Outcomes (20)
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs
At Month 3, Month 10 and Month 11.
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs
At Month 3, Month 10 and Month 11.
Concentrations for Anti-PRP.
At Month 3, Month 10 and Month 11.
Titers for rSBA-MenC.
At Month 3, Month 10 and Month 11.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.
At Month 3, Month 10 and Month 11.
- +15 more secondary outcomes
Study Arms (2)
GSK2202083A Group
EXPERIMENTALSubjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Infanrix hexa Group
ACTIVE COMPARATORSubjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Written informed consent obtained from the parent(s), Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
You may not qualify if:
- 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.
- Child in care.
- 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 randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
- 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
- History of seizures or progressive neurological disease.
- Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- 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 vaccine(s).
- Major congenital defects or serious chronic illness.
- Current febrile illness or other moderate to severe illness within 24 hours of study vaccine administration.
- Current gastrointestinal infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (34)
GSK Investigational Site
Vancouver, British Columbia, V5Z 4H4, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site
Hamilton, Ontario, L8L 5G8, Canada
GSK Investigational Site
Aix-en-Provence, 13100, France
GSK Investigational Site
Dax, 40100, France
GSK Investigational Site
Draguignan, 83300, France
GSK Investigational Site
Essey-lès-Nancy, 54270, France
GSK Investigational Site
Floirac, 33270, France
GSK Investigational Site
Le Havre, 76600, France
GSK Investigational Site
Lingolsheim, 67380, France
GSK Investigational Site
Nice, 06300, France
GSK Investigational Site
Trélazé, 49800, France
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Berchtesgaden, Bavaria, 83471, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Eschwege, Hesse, 37269, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457, Germany
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 22, 2010
Study Start
May 17, 2010
Primary Completion
October 11, 2011
Study Completion
October 11, 2011
Last Updated
August 20, 2018
Results First Posted
August 15, 2014
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.