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Influenza InfectionPhase 1/2NCT02367885

Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants

A Phase 1/2 study testing TAK-850 0.5 mL injection and TAK-850 0.25 mL injection in people with Influenza Infection, run by Takeda at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants. Read more about this study

Who is it for?
Ages 6 months to 19 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Infection
What is being tested?
TAK-850 0.5 mL injection and TAK-850 0.25 mL injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
2 sitesJapan
Study dates
Feb 2015to May 2015
Phase
Phase 1/2
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 months to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • In the opinion of the investigator or the subinvestigator, the participant and/or his/her representative and his/her guardian is capable of understanding and complying with protocol requirements.
  • The participant's representative can sign and date a written, informed consent form prior to the initiation of any study procedures.
  • The participant is a healthy Japanese child.
  • The participant is aged 6 months to 19 years, inclusive, at the time of starting to receive the study vaccine.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent until 12 weeks after the administration.

Who cannot join

  • [Only for participants at the age of 6-35 months old]
  • The participant is a preterm newborn (gestational age was less than 37 weeks) or a low-birth-weight newborn (birth weight was less than 2500 g).
  • The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine.
  • The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine.
  • The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine.
  • The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
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  • The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.
  • The participant has an armpit temperature ≥ 37.5°C prior to the initial injection of study vaccine on Day 1.
  • The participant has any medically diagnosed or suspected immune deficient condition.
  • The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to the initial injection of study vaccine. Such treatments include, but are not limited to, systemic or high dose inhaled corticosteroids (> 800 μg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation treatment or other immunosuppressive or cytotoxic drugs.
  • The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine.
  • The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis) or convulsions.
  • The participant has a functional or surgical asplenia.
  • The participant has a rash, other dermatologic conditions or tattoos which may interfere with the evaluation of injection site reaction as determined by the Investigator.
  • The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
  • The participant has a known hypersensitivity to any component of TAK-850.
  • The participant has a history of severe allergic reactions or anaphylaxis.
  • The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the initial injection of study vaccine or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial injection of study vaccine.
  • The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to the initial injection of study vaccine.
  • If female, the participant is pregnant or lactating or intending to become pregnant before signing informed consent, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • The participant has donated whole blood ≥ 200 mL within 4 weeks (28 days), ≥ 400 mL within 12 weeks (84 days), ≥ 800 mL within 52 weeks (364 days), or blood components within 2 weeks (14 days) prior to the initial injection of study vaccine.
  • In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.
  • -

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Study site

    Chuou-ku, Tokyo

  • Study site

    Setagaya-ku, Tokyo

Other trials in Japan

About this study

Official title: An Open-label, Multi-center, Phase 1/2 Study to Evaluate the Safety and Immunogenicity of an Intramuscular Injection of TAK-850 in Healthy Pediatric Subjects

The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.

Read the detailed description

The drug being tested in this study is called TAK-850, that is under development as a vaccine for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in healthy Japanese children when given as an intramuscular injection.

The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashion, The participants will be assigned to each treatment group as follows:

  • a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy Japanese children,
  • Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children,
  • Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children.

The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6 months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits (6 months to 12 years old) to the site.

Being tested
TAK-850 0.5 mL injection, TAK-850 0.25 mL injection
Keywords
Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-850 0.5 mL injectionDrug

    TAK-850 injection

  • TAK-850 0.25 mL injectionDrug

    TAK-850 intramuscular injection

Study groups in NCT02367885
Study groupRoleWhat they receive
TAK-850 0.5 mL injection (13-19 years of age)ExperimentalSingle intramuscular injection of TAK-850 0.5 mL in participants aged 13-19 years
Receives: Drug: TAK-850 0.5 mL injection
TAK-850 0.5 mL injection (3-12 years of age)ExperimentalTwo intramuscular injections of TAK-850 0.5 mL in participants aged 3-12 years old.
Receives: Drug: TAK-850 0.5 mL injection
TAK-850 0.25 mL injection (6-35 months of age)ExperimentalTwo intramuscular injections of TAK-850 0.25 mL in participants aged 6-35 months old.
Receives: Drug: TAK-850 0.25 mL injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group

    Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.

    Measured: Up to 21 days after any vaccination

  2. Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group

    Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.

    Measured: Up to 21 days after any vaccination

  3. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.

    Measured: Up to 21 days after any vaccination

  4. Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group

    Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.

    Measured: Day 22 (21 days after Vaccination)

  5. Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group

    Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.

    Measured: Day 43 (21 days after Vaccination 2)

  6. Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group

    Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

    Measured: Day 22 (21 days after Vaccination)

  7. Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group

    Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

    Measured: Day 43 (21 days after Vaccination 2)

  8. Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group

    GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.

    Measured: Day 22 (21 days after Vaccination)

  9. GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group

    GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.

    Measured: Day 43 (21 days after Vaccination 2)

Secondary outcomes (16)

  1. Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group

    Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.

    Measured: Day 22 (21 days after Vaccination 1)

  2. Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group

    Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

    Measured: Day 22 (21 days after Vaccination 1)

  3. GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group

    GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.

    Measured: Day 22 (21 days after Vaccination 1)

  4. Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)

    GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  5. Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)

    Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  6. Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)

    Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2) or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  7. GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination

    GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)

  8. GMT of SRH Antibody Titer (Egg-Derived Antigen)

    GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  9. Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40

    Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  10. Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)

    Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  11. GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination

    GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  12. GMT of HI Antibody Titer (Vero Antigen)

    GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  13. Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2

    Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  14. Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)

    Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2), or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  15. GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination

    GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

  16. GMT of SRH Antibody Titer (Vero Antigen)

    GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.

    Measured: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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 1/2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367885
Sponsor's protocol ID
TAK-850/CCT-101
Other IDs
U1111-1166-6015, JapicCTI-152807
Status last verified
Mar 2016
First submitted
13 Feb 2015
Last updated
7 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-850 0.5 mL injection and TAK-850 0.25 mL injection in people with Influenza Infection, run by Takeda at 2 sites in Japan.

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 24 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 Apr 2016). 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 Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group (time frame: Up to 21 days after any vaccination). The study lists 9 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 NCT02367885.

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 7 Apr 2016.

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