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Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01577732
First received: April 5, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+HibTM when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.


Condition Intervention Phase
Haemophilus Influenzae Type b Diseases
Diphtheria
Poliomyelitis
Pertussis
Tetanus
 Biological: Infanrix-IPV+HibTM
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From the booster dose (Day 0) up to study end (Month 1) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix-IPV+Hib Group
Children will receive a single dose of Infanrix-IPV+Hib at 12-24 months of age.
 Biological: Infanrix-IPV+HibTM
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 24 months of age at the time of vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • 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 booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
  • History of any neurological disorders or seizures.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577732

Locations
Vietnam
GSK Investigational Site
Hai Phong, Vietnam
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01577732     History of Changes
Other Study ID Numbers: 115389
Study First Received: April 5, 2012
Last Updated: March 7, 2013
Health Authority: Vietnam: Ministry of Health

Keywords provided by GlaxoSmithKline:
booster
Infanrix-IPV+HibTM
DTPa-IPV/Hib
Vietnamese toddlers

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 May 19, 2013