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Infections, RotavirusPhase 2NCT01110044

Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

A Phase 2 study testing 251154 vaccine, Infanrix hexa™ and Synflorix™ in people with Infections, Rotavirus, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 2 to 5 daysHealthy volunteers can take part
Conditions the study is for
Infections, Rotavirus
What is being tested?
251154 vaccine, Infanrix hexa™ and Synflorix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2010to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 5 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

About this study

Official title: 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.

Being tested
251154 vaccine, Infanrix hexa™, Synflorix™, Rotarix™
Keywords
Neonatal vaccination
Medical subject headings
Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 251154 vaccineBiological

    Intramuscular, single dose

  • Infanrix hexa™Biological

    Intramuscular, four doses

  • Synflorix™Biological

    Intramuscular, four doses

  • Rotarix™Biological

    Oral, two doses

Study groups in NCT01110044
Study groupRoleWhat they receive
Group AExperimentalSubjects 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.
Receives: Biological: 251154 vaccine; Biological: Infanrix hexa™; Biological: Synflorix™; Biological: Rotarix™
Group BActive comparatorSubjects 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.
Receives: Biological: Infanrix hexa™; Biological: Synflorix™; Biological: Rotarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity with respect to components of the study vaccines.

    Measured: One month after the first dose of primary vaccination.

  2. Immunogenicity with respect to components of the study vaccines.

    Measured: One month after the third dose of primary vaccination.

Secondary outcomes (7)

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

    Measured: One month after the second dose of primary vaccination.

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

    Measured: One month after the third dose of primary vaccination.

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

    Measured: One month after booster vaccination.

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

    Measured: On Day 0-Day 7 after neonatal vaccination.

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

    Measured: On Day 0-Day 3 after each dose of primary and booster vaccination.

  6. Occurrence of unsolicited adverse events (on secondary readouts).

    Measured: On Day 0-Day 30 after each vaccination.

  7. Occurrence of serious adverse events (on secondary readouts).

    Measured: From enrolment up to study end.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionAug 2012 (estimated)
  4. Study completionAug 2012 (estimated)

Why it stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01110044
Sponsor's protocol ID
112980
Status last verified
Mar 2015
First submitted
22 Apr 2010
Last updated
27 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 251154 vaccine, Infanrix hexa™ and Synflorix™ in people with Infections, Rotavirus, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity with respect to components of the study vaccines. (time frame: One month after the first dose of primary vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01110044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.

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