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

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.

Study Overview

• Status: Completed
• Conditions: Vaccines
• Intervention / Treatment: Biological: 13vPnC

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chennai, Tamil Nadu, India, 600034
    • Kanchi Kamakoti CHILDS Trust Hospital
  • Karnataka
    • Bengaluru, Karnataka, India, 560017
      • Manipal Hospital / Department of Pediatrics
  • Maharashtra
    • Pune, Maharashtra, India, 411 011
      • KEM Hospital Research Centre
  • Punjab
    • Ludhiana, Punjab, India, 141 008
      • Christian Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.

2. Healthy male or female children 6 to 17 years of age at the time of vaccination.
3. Parent(s)/legal guardian(s)/child willing and able to comply with scheduled visits, treatment plan, and other study procedures.
4. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.
4. Contraindication to vaccination with pneumococcal conjugate vaccines (refer to local package insert).
5. Previous vaccination with licensed or investigational pneumococcal vaccine.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. History of culture-proven invasive disease caused by S pneumoniae.
8. Major known congenital malformation or serious chronic disorder.
9. Known or suspected immune deficiency or suppression.
10. 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.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 13vPnC provided as a 0.5-mL dose in a prefilled syringe; All subjects receive a single dose (0.5mL) of 13vPnC	Biological: 13vPnC; All subjects receive a single dose (0.5mL) of 13vPnC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days after vaccination on Day 1 (up to Day 7)
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.)	Within 7 days after vaccination on Day 1 (up to Day 7)
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.	up to 1 month after vaccination on Day 1

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2018
• Primary Completion (ACTUAL): April 17, 2019
• Study Completion (ACTUAL): April 17, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B1851190; 13VPNC 6 TO 17 YEARS IN INDIA (OTHER: Alias Study Number); 2019-000890-21 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No