- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01110044
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
March 26, 2015 updated by: GlaxoSmithKline
Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 days to 5 days (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- A male or female infant between, and including, 2 and 5 days of age at the time of randomisation.
- Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive.
- Subjects born to a mother seronegative for hepatitis B surface antigen.
- Subjects with a birth weight >= 2.5 kg.
- Subjects with a 5-minute Apgar score >= 7.
- Healthy subjects as established by medical history and clinical examination
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- Born to a mother known or suspected to be seropositive for HIV.
- Family history of congenital or hereditary immunodeficiency.
- Children in care..
- Neonatal jaundice requiring systemic treatment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines.
- 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.
- 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, including perinatal brain damage.
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 temperature >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
|
Oral, two doses
Intramuscular, single dose
Intramuscular, four doses
Intramuscular, four doses
|
Active Comparator: Group B
Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
|
Oral, two doses
Intramuscular, four doses
Intramuscular, four doses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity with respect to components of the study vaccines.
Time Frame: One month after the first dose of primary vaccination.
|
One month after the first dose of primary vaccination.
|
Immunogenicity with respect to components of the study vaccines.
Time Frame: One month after the third dose of primary vaccination.
|
One month after the third dose of primary vaccination.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time Frame: One month after the second dose of primary vaccination.
|
One month after the second dose of primary vaccination.
|
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time Frame: One month after the third dose of primary vaccination.
|
One month after the third dose of primary vaccination.
|
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Time Frame: One month after booster vaccination.
|
One month after booster vaccination.
|
Occurrence of solicited local and general symptoms (on secondary readouts).
Time Frame: On Day 0-Day 7 after neonatal vaccination.
|
On Day 0-Day 7 after neonatal vaccination.
|
Occurrence of solicited local and general symptoms (on secondary readouts).
Time Frame: On Day 0-Day 3 after each dose of primary and booster vaccination.
|
On Day 0-Day 3 after each dose of primary and booster vaccination.
|
Occurrence of unsolicited adverse events (on secondary readouts).
Time Frame: On Day 0-Day 30 after each vaccination.
|
On Day 0-Day 30 after each vaccination.
|
Occurrence of serious adverse events (on secondary readouts).
Time Frame: From enrolment up to study end.
|
From enrolment up to study end.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
April 22, 2010
First Submitted That Met QC Criteria
April 22, 2010
First Posted (Estimate)
April 23, 2010
Study Record Updates
Last Update Posted (Estimate)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112980
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.
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