Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Infections, Rotavirus Clinical Trial

Official title:

Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01110044
• Other study ID #: 112980
• Status: Withdrawn
• Phase: Phase 2
• First received: April 22, 2010
• Last updated: March 26, 2015
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Agence Fédérale des Médicaments et des Produits de la SantéCanada: Biologics and Genetic Therapies Directorate (BGTD)Germany: Paul-Ehrlich-InstitutSweden: Medical Products AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• 251154 vaccine
Intramuscular, single dose
• Infanrix hexa™
Intramuscular, four doses
• Synflorix™
Intramuscular, four doses
• Rotarix™
Oral, two doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity with respect to components of the study vaccines.		One month after the first dose of primary vaccination.	No
Primary	Immunogenicity with respect to components of the study vaccines.		One month after the third dose of primary vaccination.	No
Secondary	Immunogenicity with respect to components of the study vaccines (on secondary readouts).		One month after the second dose of primary vaccination.	No
Secondary	Immunogenicity with respect to components of the study vaccines (on secondary readouts).		One month after the third dose of primary vaccination.	No
Secondary	Immunogenicity with respect to components of the study vaccines (on secondary readouts).		One month after booster vaccination.	No
Secondary	Occurrence of solicited local and general symptoms (on secondary readouts).		On Day 0-Day 7 after neonatal vaccination.	No
Secondary	Occurrence of solicited local and general symptoms (on secondary readouts).		On Day 0-Day 3 after each dose of primary and booster vaccination.	No
Secondary	Occurrence of unsolicited adverse events (on secondary readouts).		On Day 0-Day 30 after each vaccination.	No
Secondary	Occurrence of serious adverse events (on secondary readouts).		From enrolment up to study end.	No