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Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Primary Purpose

Infections, Rotavirus

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

251154 vaccine

Infanrix hexa™

Synflorix™

Rotarix™

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Neonatal vaccination

Eligibility Criteria

2 Days - 5 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Immunogenicity with respect to components of the study vaccines.

Secondary Outcome Measures

Immunogenicity with respect to components of the study vaccines (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).

Full Information

NCT ID

NCT01110044

First Posted

April 22, 2010

Last Updated

March 26, 2015

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01110044

Brief Title

Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.

Study Start Date

April 2010 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Rotavirus

Keywords

Neonatal vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

251154 vaccine

Intervention Description

Intramuscular, single dose

Intervention Type

Biological

Intervention Name(s)

Infanrix hexa™

Intervention Description

Intramuscular, four doses

Intervention Type

Biological

Intervention Name(s)

Synflorix™

Intervention Description

Intramuscular, four doses

Intervention Type

Biological

Intervention Name(s)

Rotarix™

Intervention Description

Oral, two doses

Primary Outcome Measure Information:

Title

Immunogenicity with respect to components of the study vaccines.

Time Frame

One month after the first dose of primary vaccination.

Title

Immunogenicity with respect to components of the study vaccines.

Time Frame

One month after the third dose of primary vaccination.

Secondary Outcome Measure Information:

Title

Immunogenicity with respect to components of the study vaccines (on secondary readouts).

Time Frame

One month after the second dose of primary vaccination.

Title

Immunogenicity with respect to components of the study vaccines (on secondary readouts).

Time Frame

One month after the third dose of primary vaccination.

Title

Immunogenicity with respect to components of the study vaccines (on secondary readouts).

Time Frame

One month after booster vaccination.

Title

Occurrence of solicited local and general symptoms (on secondary readouts).

Time Frame

On Day 0-Day 7 after neonatal vaccination.

Title

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.

Title

Occurrence of unsolicited adverse events (on secondary readouts).

Time Frame

On Day 0-Day 30 after each vaccination.

Title

Occurrence of serious adverse events (on secondary readouts).

Time Frame

From enrolment up to study end.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Days

Maximum Age & Unit of Time

5 Days

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

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Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

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