Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine

NCT01110044 | Withdrawn Phase 2

• 1 other identifier: 112980
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infections, Rotavirus

Keywords

Neonatal vaccination

Outcome Measures

Primary Outcomes (2)

• Immunogenicity with respect to components of the study vaccines.

  One month after the first dose of primary vaccination.

• Immunogenicity with respect to components of the study vaccines.

  One month after the third dose of primary vaccination.

Secondary Outcomes (7)

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

  One month after the second dose of primary vaccination.

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

  One month after the third dose of primary vaccination.

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

  One month after booster vaccination.

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

  On Day 0-Day 7 after neonatal vaccination.

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

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

Study Arms (2)

Group A

EXPERIMENTAL

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.

Biological: 251154 vaccine; Biological: Infanrix hexa™; Biological: Synflorix™; Biological: Rotarix™

Group B

ACTIVE COMPARATOR

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.

Biological: Infanrix hexa™; Biological: Synflorix™; Biological: Rotarix™

Interventions

251154 vaccine BIOLOGICAL

Intramuscular, single dose

Group A

Infanrix hexa™ BIOLOGICAL

Intramuscular, four doses

Group A; Group B

Synflorix™ BIOLOGICAL

Intramuscular, four doses

Group A; Group B

Rotarix™ BIOLOGICAL

Oral, two doses

Group A; Group B

Eligibility Criteria

• Age: 2 Days - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Rotavirus Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; PHiD-CV vaccine; RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 27, 2015

Record last verified: 2015-03