Last updated: 11/03/2018 13:57:38
Study of a birth dose of GlaxoSmithKline Biologicals’ 251154 vaccine
GSK study ID
112980
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Immunogenicity and safety of a birth dose of GlaxoSmithKline Biologicals’ reduced-antigen-content tri-component pertussis (251154) vaccine
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Immunogenicity with respect to components of the study vaccines.
Timeframe: One month after the first dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines.
Timeframe: One month after the third dose of primary vaccination.
Secondary outcomes:
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Timeframe: One month after the second dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Timeframe: One month after the third dose of primary vaccination.
Immunogenicity with respect to components of the study vaccines (on secondary readouts).
Timeframe: One month after booster vaccination.
Occurrence of solicited local and general symptoms (on secondary readouts).
Timeframe: On Day 0–Day 7 after neonatal vaccination.
Occurrence of solicited local and general symptoms (on secondary readouts).
Timeframe: On Day 0–Day 3 after each dose of primary and booster vaccination.
Occurrence of unsolicited adverse events (on secondary readouts).
Timeframe: On Day 0–Day 30 after each vaccination.
Occurrence of serious adverse events (on secondary readouts).
Timeframe: From enrolment up to study end.
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
GSK357941A, SB210602, SB217744
Collaborators
Not applicable
Study date(s)
April 2010 to August 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
2 - 5 days
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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