Infections, StreptococcalPhase 3NCT01641133
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
A Phase 3 study testing Synflorix (3-Dose), Synflorix (2-Dose) and Synflorix (Single Dose) in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 3 sites in Mexico.
Trial summary
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
- What is being tested?
- Synflorix (3-Dose), Synflorix (2-Dose) and Synflorix (Single Dose)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 3 sitesMexico
- Study dates
- 4 Sep 2012to 7 May 2014
- 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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, 6-12 weeks of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
Show all 11Show fewer
- Major congenital defects or serious chronic illness.
- History of any seizures or progressive neurological disease.
- Administration of immunoglobulins and/or blood products since birth or planned use during the study.
- Acute disease and/or fever at the time of enrolment.
- Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
GSK Investigational Site
Cuernavaca, Morelos, 62210
GSK Investigational Site
México, 04530
GSK Investigational Site
Monterrey, Nuevo León, 64460
About this study
Official title: Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.
Read the detailed description
This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.
- Being tested
- Synflorix (3-Dose), Synflorix (2-Dose), Synflorix (Single Dose), Prevenar 13 (Single Dose), Prevenar 13 (2-Dose)
- Keywords
- pneumococcal conjugate vaccine, Synflorix, Prevnar 13, Pneumococcal diseases
- Medical subject headings
- Streptococcal Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synflorix (3-Dose)Biological
3 doses administered intramuscularly
Synflorix (2-Dose)Biological
2 doses administered intramuscularly
Synflorix (Single Dose)Biological
1 dose administered intramuscularly
Prevenar 13 (Single Dose)Biological
1 dose administered intramuscularly
Prevenar 13 (2-Dose)Biological
2 doses administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Synflorix Group | Active comparator | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. Receives: Biological: Synflorix (3-Dose) |
| Prevnar 1 Group | Experimental | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. Receives: Biological: Synflorix (2-Dose); Biological: Prevenar 13 (Single Dose) |
| Prevnar 2 Group | Experimental | Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. Receives: Biological: Synflorix (Single Dose); Biological: Prevenar 13 (2-Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period
The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.
Measured: Within 31-day (Day 0-Day 30) after any dose of primary vaccination
Secondary outcomes (11)
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Measured: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Measured: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period
Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period
Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Measured: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period
The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.
Measured: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Unsolicited AEs - Primary Period
An unsolicited AE 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: During the 31-day (Days 0-30) post-primary vaccination period
Number of Subjects With Unsolicited AEs - Booster Period
An unsolicited AE 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From first vaccination (Month 0) up to study end (11-14 months)
Antibody Concentrations Against Pneumococcal Serotypes
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.
Measured: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)
Concentrations of Antibodies Against Protein D (Anti-PD)
Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
Measured: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes
The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.
Measured: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start4 Sep 2012
- Primary completion15 Jul 2013
- Study completion7 May 2014
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 Infections, StreptococcalStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 457 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
- NCT01641133
- Sponsor's protocol ID
- 115992
- Other IDs
- 2013-003479-36
- Status last verified
- Feb 2021
- First submitted
- 12 Jul 2012
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.
PubMed 33297773
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-dose Primary Vaccination With Either GSK Biologicals' 10-valent Pneumococcal Vaccine (Synflorix™) or Pfizer's Prevenar 13™ or Both Vaccines Followed by a Booster Dose of Synflorix™
- ClinicalTrials.gov ID
- NCT01641133
- Acronym / sponsor ID
- 115992
- Keywords
- pneumococcal conjugate vaccine, Synflorix, Prevnar 13, Pneumococcal diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2012 (actual)
- Primary completion
- 15 Jul 2013 (actual)
- Study completion
- 7 May 2014 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.
Detailed description
This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synflorix Group | Active comparator | Biological: Synflorix (3-Dose)Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
| Prevnar 1 Group | Experimental | Biological: Synflorix (2-Dose), Biological: Prevenar 13 (Single Dose)Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
| Prevnar 2 Group | Experimental | Biological: Synflorix (Single Dose), Biological: Prevenar 13 (2-Dose)Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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, 6-12 weeks of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Key exclusion criteria (11 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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 |
|---|---|---|
| Synflorix (3-Dose)3 doses administered intramuscularly | Biological | Synflorix Group |
| Synflorix (2-Dose)2 doses administered intramuscularly | Biological | Prevnar 1 Group |
| Synflorix (Single Dose)1 dose administered intramuscularly | Biological | Prevnar 2 Group |
| Prevenar 13 (Single Dose)1 dose administered intramuscularly | Biological | Prevnar 1 Group |
| Prevenar 13 (2-Dose)2 doses administered intramuscularly | Biological | Prevnar 2 Group |
Primary outcome
Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period
Time frame: Within 31-day (Day 0-Day 30) after any dose of primary vaccination
The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.
11 secondary outcomes
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period
Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period
Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Unsolicited AEs - Primary Period
Time frame: During the 31-day (Days 0-30) post-primary vaccination period
Number of Subjects With Unsolicited AEs - Booster Period
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From first vaccination (Month 0) up to study end (11-14 months)
Antibody Concentrations Against Pneumococcal Serotypes
Time frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)
Concentrations of Antibodies Against Protein D (Anti-PD)
Time frame: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes
Time frame: At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33297773de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request 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
3 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 Synflorix (3-Dose), Synflorix (2-Dose) and Synflorix (Single Dose) in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 3 sites in Mexico.
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 11 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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 27 Feb 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 Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period (time frame: Within 31-day (Day 0-Day 30) after any dose of primary vaccination). 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 NCT01641133, 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 2 Mar 2021.