Haemophilus Influenzae Type bPhase 3NCT00964028
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
A Phase 3 study testing Infanrix™-IPV/Hib in people with Haemophilus Influenzae Type b and Acellular Pertussis, run by GlaxoSmithKline at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria
- What is being tested?
- Infanrix™-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2009to 12 Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Infanrix™-IPV/Hib
- Keywords
- Combined vaccine
- Medical subject headings
- Haemophilus Infections, Diphtheria, Tetanus, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix™-IPV/HibBiological
Intramuscular, three doses
| Study group | Role | What they receive |
|---|---|---|
| INFANRIX-IPV/HIB M2-M3-M4 GROUP | Experimental | 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. Receives: Biological: Infanrix™-IPV/Hib |
| INFANRIX-IPV/HIB M3-M4-M5 GROUP | Experimental | 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. Receives: Biological: Infanrix™-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after each dose and across doses
Number of Subjects With Any Solicited General Symptoms
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.
Measured: During the 4-day (Days 0-3) follow-up period after each dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Measured: During the 31-day (Days 0-30) follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
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.
Measured: During the whole study period (from Day 0 until Month 3 or Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study start1 Dec 2009
- Primary completion12 Apr 2010
- Study completion12 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haemophilus Influenzae Type bStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964028
- Sponsor's protocol ID
- 112065
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2009
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants
- ClinicalTrials.gov ID
- NCT00964028
- Acronym / sponsor ID
- 112065
- Keywords
- Combined vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2009
- Primary completion
- 12 Apr 2010 (actual)
- Study completion
- 12 Apr 2010 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INFANRIX-IPV/HIB M2-M3-M4 GROUP | Experimental | Biological: Infanrix™-IPV/HibHealthy 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. |
| INFANRIX-IPV/HIB M3-M4-M5 GROUP | Experimental | Biological: Infanrix™-IPV/HibHealthy 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. |
Who may qualify
- Ages
- 60 to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infanrix™-IPV/HibIntramuscular, three doses | Biological | INFANRIX-IPV/HIB M2-M3-M4 GROUP, INFANRIX-IPV/HIB M3-M4-M5 GROUP |
Primary outcome
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
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
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
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.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) follow-up period after each vaccination
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.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the whole study period (from Day 0 until Month 3 or Month 4)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infanrix™-IPV/Hib in people with Haemophilus Influenzae Type b and Acellular Pertussis, run by GlaxoSmithKline at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.