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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01577732
First received: April 5, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ 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
Acellular Pertussis
Haemophilus Influenzae Type b
Tetanus
Poliomyelitis
Diphtheria
Biological: Infanrix-IPV+Hib™
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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.

  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination. ] [ Designated as safety issue: No ]
    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

  • Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-30). ] [ Designated as safety issue: No ]
    SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.


Enrollment: 321
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix-IPV+Hib Group
Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Biological: Infanrix-IPV+Hib™
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 3, 2014
Last Updated: April 3, 2014
Health Authority: Vietnam: Ministry of Health

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

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014