Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964028
First received: August 20, 2009
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.


Condition Intervention Phase
Poliomyelitis
Haemophilus Influenzae Type b Disease
Diphtheria
Pertussis
Tetanus
Biological: Infanrix™-IPV/Hib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local/general symptoms [ Time Frame: During the 4-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Day 0 up to study completion ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will be administered DTPa-IPV/Hib at 2, 3, and 4 months of age
Biological: Infanrix™-IPV/Hib
Intramuscular, three doses
Experimental: Group B
Subjects will be administered DTPa-IPV/Hib at 3, 4, and 5 months of age
Biological: Infanrix™-IPV/Hib
Intramuscular, three doses

  Eligibility

Ages Eligible for Study:   60 Days to 90 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
  • 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.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.
  • Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964028

Locations
China, Guangxi
GSK Investigational Site
Wuzhou, Guangxi, China, 543100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00964028     History of Changes
Other Study ID Numbers: 112065
Study First Received: August 20, 2009
Last Updated: September 5, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Combined vaccine

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 16, 2014