- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00964028
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
April 27, 2018 updated by: GlaxoSmithKline
Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangxi
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Wuzhou, Guangxi, China, 543100
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INFANRIX-IPV/HIB M2-M3-M4 GROUP
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
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Intramuscular, three doses
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Experimental: INFANRIX-IPV/HIB M3-M4-M5 GROUP
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
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Intramuscular, three doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Any Solicited Local Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of any local symptom regardless of intensity grade.
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During the 4-day (Days 0-3) follow-up period after each dose and across doses
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Number of Subjects With Any Solicited General Symptoms
Time Frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses
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Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)].
Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
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During the 4-day (Days 0-3) follow-up period after each dose and across doses
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Number of Subjects With Unsolicited Adverse Events (AEs)
Time Frame: During the 31-day (Days 0-30) follow-up period after each vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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During the 31-day (Days 0-30) follow-up period after each vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the whole study period (from Day 0 until Month 3 or Month 4)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the whole study period (from Day 0 until Month 3 or Month 4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
April 12, 2010
Study Completion (Actual)
April 12, 2010
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 21, 2009
First Posted (Estimate)
August 24, 2009
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Corynebacterium Infections
- Myelitis
- Diphtheria
- Poliomyelitis
Other Study ID Numbers
- 112065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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