Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Rotavirus
Intervention: 251154 vaccine (Biological); Infanrix hexa™ (Biological); Synflorix™ (Biological); Rotarix™ (Biological)
Phase: Phase 2
Status: Withdrawn
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Immunogenicity with respect to components of the study vaccines.Immunogenicity with respect to components of the study vaccines.
Secondary outcome: Immunogenicity with respect to components of the study vaccines (on secondary readouts).Immunogenicity with respect to components of the study vaccines (on secondary readouts). Immunogenicity with respect to components of the study vaccines (on secondary readouts). Occurrence of solicited local and general symptoms (on secondary readouts). Occurrence of solicited local and general symptoms (on secondary readouts). Occurrence of unsolicited adverse events (on secondary readouts). Occurrence of serious adverse events (on secondary readouts).
Eligibility
Minimum age: N/A.
Maximum age: 5 Days.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: April 2010
Last updated: March 26, 2015
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