Hepatitis APhase 3NCT00197236
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
A Phase 3 study testing Havrix™, Infanrix™ and ActHIB™ in people with Hepatitis A, run by GlaxoSmithKline at 22 sites in United States.
Trial summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. Read more about this study
- Who is it for?
- Ages 12 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Havrix™, Infanrix™ and ActHIB™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 22 sitesUnited States
- Study dates
- 11 Nov 2003to 3 Dec 2007
- 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 12 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
- A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase,
- Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™.
- Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™,
- Written informed consent obtained from the parents or guardian of the subject,
- Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
- Parents/guardian of the subject must have a telephone or be able to be contacted by telephone.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period,
- Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.
- Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s).
- Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™.
- Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
- Previous vaccination against hepatitis A,
Show all 18Show fewer
- History or known exposure to hepatitis A,
- History of diphtheria, tetanus, pertussis and/or Haemophilus influenza type b,
- Known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenza type b within 31 days prior to the start of the study,
- History of non-response to any vaccine in the current routine immunization schedule,
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
- A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix™, Infanrix™ or ActHIB™ including 2-phenoxyethanol, neomycin and gelatin,
- History of hypersensitivity/allergic reaction to latex
- Major congenital defects or serious chronic illness,
- History of any neurologic disorder
- Acute disease at the time of vaccination.
- Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period, i.e., the Enrolment Phase, the Active Phase and the Extended Safety Follow-up Phase
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
GSK Investigational Site
Beaumont, Texas, 77701
GSK Investigational Site
Bellevue, Pennsylvania, 15202
GSK Investigational Site
Bismarck, North Dakota, 58501
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Danville, Virginia, 24549
GSK Investigational Site
Hershey, Pennsylvania, 17033
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
Long Branch, New Jersey, 07740
GSK Investigational Site
Martinez, Georgia, 30907
GSK Investigational Site
Mechanicsville, Virginia, 23111
GSK Investigational Site
Oakland, California, 94612
GSK Investigational Site
Pembroke Pines, Florida, 33027
GSK Investigational Site
Phoenix, Arizona, 85029
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
San Ramon, California, 94583
GSK Investigational Site
Waterloo, Iowa, 50702
GSK Investigational Site
Wilmington, Delaware, 19810
GSK Investigational Site
Youngstown, Ohio, 44501
About this study
Official title: Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.
- Conditions
- Hepatitis A
- Being tested
- Havrix™, Infanrix™, ActHIB™
- Keywords
- Hepatitis A
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Havrix™Biological
2 intramuscular injections, 6 months apart
Infanrix™Biological
1 intramuscular injection
ActHIB™Biological
1 intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Havrix Group | Active comparator | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. Receives: Biological: Havrix™ |
| Infanrix + ActHIB→Havrix Group | Experimental | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. Receives: Biological: Havrix™; Biological: Infanrix™; Biological: ActHIB™ |
| Havrix + Infanrix + ActHIB Group | Active comparator | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. Receives: Biological: Havrix™; Biological: Infanrix™; Biological: ActHIB™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Measured: 31 days following the second dose of Havrix™
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Measured: 31 days following the administration of Infanrix™ and ActHIB
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
Measured: 31 days following the administration of Infanrix™ and ActHIB
Secondary outcomes (11)
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as International Units per milliliter (IU/mL).
Measured: 31 days following the administration of Infanrix™ and ActHIB
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
GMCs are expressed as microgram/milliliter (µg/mL).
Measured: 31 days following the administration of Infanrix™ and ActHIB
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.
Measured: 31 days following the administration of Infanrix™ and ActHIB
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Measured: 31 days following the first dose of Havrix™
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Measured: 31 days following the first dose of Havrix™
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).
Measured: 31 days following the second dose of Havrix™
Number of Subjects With Vaccine Response to Havrix™.
Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.
Measured: 31 days following the second dose
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.
Measured: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.
Measured: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An Adverse Event is 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.
Measured: 31-day period following each dose of study vaccine(s)
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.
Measured: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start11 Nov 2003
- Primary completion3 Dec 2007
- Study completion3 Dec 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis AStudies 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
- 468 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
- NCT00197236
- Sponsor's protocol ID
- 208109/232
- Status last verified
- Jan 2017
- First submitted
- 15 Sep 2005
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.
PubMed 21494175
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With GSK Biologicals' DTaP Vaccine (Infanrix™) and Aventis Pasteur's Haemophilus b Conjugate Vaccine (ActHIB) in Healthy Children 15 Months of Age
- ClinicalTrials.gov ID
- NCT00197236
- Acronym / sponsor ID
- 208109/232
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2003
- Primary completion
- 3 Dec 2007 (actual)
- Study completion
- 3 Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 24 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3) Infanrix™ and ActHIB followed by Havrix™ one month later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Havrix Group | Active comparator | Biological: Havrix™Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Experimental | Biological: Havrix™, Biological: Infanrix™, Biological: ActHIB™Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix + Infanrix + ActHIB Group | Active comparator | Biological: Havrix™, Biological: Infanrix™, Biological: ActHIB™Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
Who may qualify
- Ages
- 12 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
- A male or female child 12 or 13 months of age at the time of entry into the Enrolment Phase,
- Subjects must have previously received three doses each of DTaP and Hib vaccines during the first year of life. The three doses of DTaP vaccine must have been administered as either Infanrix™ or Pediarix™ and the three doses of Hib vaccine must have been administered as ActHIB™, HibTITER™, OmniHIB™.
- Subjects who, at 15 months of age, will have had at least six months elapse since their third dose of Infanrix™ or Pediarix™,
- Written informed consent obtained from the parents or guardian of the subject,
Key exclusion criteria (18 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 31 days preceding the first dose of study vaccine, or planned use during the study period,
- Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period.
- Planned administration or administration of any vaccine not foreseen by the study protocol during the period 42 days before and 31 days after each dose of study vaccine(s).
- Previous vaccination against DTaP using a commercially-available brand other than Infanrix™ or Pediarix™ or against Hib using a commercially-available brand other than ActHIB™, HibTITER™ or OmniHIB™.
- Previous vaccination with more than three doses of DTaP-containing vaccines or more than three doses of Hib-containing vaccines.
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 |
|---|---|---|
| Havrix™2 intramuscular injections, 6 months apart | Biological | Havrix + Infanrix + ActHIB Group, Havrix Group, Infanrix + ActHIB→Havrix Group |
| Infanrix™1 intramuscular injection | Biological | Havrix + Infanrix + ActHIB Group, Infanrix + ActHIB→Havrix Group |
| ActHIB™1 intramuscular injection | Biological | Havrix + Infanrix + ActHIB Group, Infanrix + ActHIB→Havrix Group |
Primary outcome
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
Time frame: 31 days following the second dose of Havrix™
Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.
11 secondary outcomes
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
Time frame: 31 days following the administration of Infanrix™ and ActHIB
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
Time frame: 31 days following the first dose of Havrix™
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
Time frame: 31 days following the first dose of Havrix™
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
Time frame: 31 days following the second dose of Havrix™
Number of Subjects With Vaccine Response to Havrix™.
Time frame: 31 days following the second dose
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Time frame: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Time frame: 4-day period following each dose of study vaccine(s)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: 31-day period following each dose of study vaccine(s)
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
Time frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21494175Trofa AF, Klein NP, Paul IM, Michaels MG, Goessler M, Chandrasekaran V, Blatter M. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with Diphtheria-tetanus-acellular pertussis and haemophilus influenzae type B vaccines in children 15 months of age. Pediatr Infect Dis J. 2011 Sep;30(9):e164-9. doi: 10.1097/INF.0b013e31821b8a7d.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Havrix™, Infanrix™ and ActHIB™ in people with Hepatitis A, run by GlaxoSmithKline at 22 sites in United States.
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 7 inclusion and 18 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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 24 Jul 2009). 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 Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix (time frame: 31 days following the second dose of Havrix™). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197236, which also lists 1 linked publication.
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 20 Aug 2018.