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AzTrials

VaccinesPhase 4NCT03777865

Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India

A Phase 4 study testing 13vPnC in people with Vaccines, run by Pfizer at 4 sites in India.

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

This is a Phase 4, open-label, single-arm, multicenter study in which subjects 6 to 17 years of age will receive 1 dose of 13vPnC. Read more about this study

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Vaccines
What is being tested?
13vPnC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesIndia
Study dates
14 Dec 2018to 17 Apr 2019
Phase
Phase 4
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 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
  • Note: The subject's assent may also be required depending on local requirements.
  • Healthy male or female children 6 to 17 years of age at the time of vaccination.
  • Parent(s)/legal guardian(s)/child willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Male subject not able to father children, male subject who is able to father children and willing to use a highly effective method of contraception, female subject not of childbearing potential, or female subject of childbearing potential and at risk for pregnancy who is willing to use a highly effective method of contraception.
  • Note: Female subjects of childbearing potential are defined as female subjects 9 years old or have experienced menarche, whichever is earlier, and who are anatomically and functionally able to conceive.

Who cannot join

  • Child who is a family member of:
  • Investigator site staff members directly involved in the conduct of the study;
  • Site staff members otherwise supervised by the investigator;
  • Pfizer employees directly involved in the conduct of the study.
  • Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in observational studies is permitted.
  • History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.
Show all 14Show fewer
  • Contraindication to vaccination with pneumococcal conjugate vaccines (refer to local package insert).
  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • History of culture-proven invasive disease caused by S pneumoniae.
  • Major known congenital malformation or serious chronic disorder.
  • Known or suspected immune deficiency or suppression.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant females; breastfeeding females; fertile males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.

Trial locations and contacts

4 sites in 1 country.

India4 sites

  • Manipal Hospital / Department of Pediatrics

    Bengaluru, Karnataka, 560017

  • Kanchi Kamakoti CHILDS Trust Hospital

    Chennai, Tamil Nadu, 600034

  • Christian Medical College

    Ludhiana, Punjab, 141 008

  • KEM Hospital Research Centre

    Pune, Maharashtra, 411 011

Other trials in India

About this study

Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN CHILDREN 6 TO 17 YEARS OF AGE IN INDIA

This is a Phase 4, open-label, single-arm, multicenter study in which subjects 6 to 17 years of age will receive 1 dose of 13vPnC.

Read the detailed description

A Phase 4, open-label, single-arm, multicenter study to describe the safety of 13-valent Pneumococcal Conjugate Vaccine in children 6 to 17 years of age in India.

Conditions
Vaccines
Being tested
13vPnC

What participants receive

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

  • 13vPnCBiological

    All subjects receive a single dose (0.5mL) of 13vPnC

Study groups in NCT03777865
Study groupRoleWhat they receive
13vPnC provided as a 0.5-mL dose in a prefilled syringeExperimentalAll subjects receive a single dose (0.5mL) of 13vPnC
Receives: Biological: 13vPnC

What is being measured

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

  1. Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination

    Local reactions (redness, swelling and pain [tenderness]) at the 13vPnC injection site were monitored daily for 7 days after vaccination. Redness and swelling were measured and recorded in a measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as; any (any redness or swelling at the injection site), mild (1 to 4 measuring device units = 0.5 to 2.0 cm), moderate (5 to 14 measuring device units = 2.5 to 7.0 cm) and severe (greater than [>]14 measuring device units = >7.0 cm). Pain (tenderness) at injection site was categorized as; any: any pain at the injection site, mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.

    Measured: Within 7 days after vaccination on Day 1 (up to Day 7)

  2. Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination

    Systemic events included fever, fatigue(tiredness), headache, muscle pain, joint pain, vomiting and diarrhea. Fever: greater than or equal to (>=) 38.0 degrees Celsius (C), >=38.0 degrees C to <=38.4 degrees C, >=38.5 to <=38.9 degrees C, 39.0 to 40.0 degrees C, > 40.0 degrees C. Fatigue, headache, muscle pain and joint pain graded as any (any fatigue, headache, muscle pain, joint pain), mild(did not interfere with activity), moderate(some interference with activity) or severe(prevented daily routine activity). Vomiting was graded as any (any vomiting), mild (1-2 times in 24 hours [hrs.]), moderate(>2 times in 24 hrs.) or severe (required intravenous hydration). Diarrhea was graded as any(any diarrhea), mild (2-3 loose stools in 24 hrs.), moderate(4-5 loose stools in 24 hrs.) or severe(>=6 loose stools in 24 hrs.)

    Measured: Within 7 days after vaccination on Day 1 (up to Day 7)

  3. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was 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; congenital anomaly or that was considered to be an important medical event. Treatment-emergent were events between first dose of study drug and up to 1 month that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

    Measured: up to 1 month after vaccination on Day 1

Timeline

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

  1. First posted17 Dec 2018
  2. Study start14 Dec 2018
  3. Primary completion17 Apr 2019
  4. Study completion17 Apr 2019

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777865
Sponsor's protocol ID
B1851190
Other IDs
13VPNC 6 TO 17 YEARS IN INDIA, 2019-000890-21, 2019
Status last verified
Apr 2020
First submitted
4 Dec 2018
Last updated
21 Apr 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 13vPnC in people with Vaccines, run by Pfizer at 4 sites in India.

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 6 inclusion and 14 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 21 Apr 2020). 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?

Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination (time frame: Within 7 days after vaccination on Day 1 (up to Day 7)). 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 NCT03777865.

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 21 Apr 2020.

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