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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03777865
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Arm: 1
• Actual Duration (Months): 4.1
• Patients Per Site: 25
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaccines	Biological: 13vPnC	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Dec 14, 2018
• Actual Primary Completion Date: Apr 17, 2019
• Actual Study Completion Date: Apr 17, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

   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.

2. Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination [Within 7 days after vaccination on Day 1 (up to Day 7)]

   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.)

3. Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [up to 1 month after vaccination on Day 1]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. Healthy male or female children 6 to 17 years of age at the time of vaccination.

2. Parent(s)/legal guardian(s)/child willing and able to comply with scheduled visits, treatment plan, and other study procedures.

3. 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.

1. 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.

2. History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.

3. Contraindication to vaccination with pneumococcal conjugate vaccines (refer to local package insert).

4. Previous vaccination with licensed or investigational pneumococcal vaccine.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorder.

8. Known or suspected immune deficiency or suppression.

9. 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.

10. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manipal Hospital / Department of Pediatrics	Bengaluru	Karnataka	India	560017
2	KEM Hospital Research Centre	Pune	Maharashtra	India	411 011
3	Christian Medical College	Ludhiana	Punjab	India	141 008
4	Kanchi Kamakoti CHILDS Trust Hospital	Chennai, Tamil Nadu		India	600034

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Dec 5, 2017
• Statistical Analysis Plan - Apr 26, 2018

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03777865
• Other Study ID Numbers: B1851190; 13VPNC 6 TO 17 YEARS IN INDIA; 2019-000890-21
• First Posted: Dec 17, 2018
• Last Update Posted: Apr 21, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	The study was conducted in 1 country from 14 December 2018 to 17 April 2019. A total of 100 participants were enrolled.

Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.
Period Title: Overall Study
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.28 (2.985)
Sex: Female, Male (Count of Participants)
Female	47 47%
Male	53 53%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	100 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	100 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination
Description	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.
Time Frame	Within 7 days after vaccination on Day 1 (up to Day 7)

Outcome Measure Data

Analysis Population Description

The safety population included all participants who received 1 dose of an investigational product. Here, "Overall Number of Participants Analyzed"=Participants evaluable for this outcome measure and "Number Analyzed"=Participants evaluable at specific rows.

Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Measure Participants	92
Redness: Any	14.9 14.9%
Redness: Mild	14.9 14.9%
Redness: Moderate	0 0%
Redness: Severe	0 0%
Swelling: Any	17.6 17.6%
Swelling: Mild	17.6 17.6%
Swelling: Moderate	0 0%
Swelling: Severe	0 0%
Pain: Any	67.0 67%
Pain: Mild	45.1 45.1%
Pain: Moderate	19.8 19.8%
Pain: Severe	2.2 2.2%

2. Primary Outcome

Title	Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination
Description	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.)
Time Frame	Within 7 days after vaccination on Day 1 (up to Day 7)

Outcome Measure Data

Analysis Population Description

The safety population included all participants who received 1 dose of an investigational product. Here "Overall Number of Participants Analyzed"=Participants evaluable for this outcome measure and "Number Analyzed"=Participants evaluable at specific rows.

Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Measure Participants	83
Fever: >=38 degrees C	4.1 4.1%
Fever: >=38 degrees C to <=38.4 degrees C	1.4 1.4%
Fever:>=38.5 degrees C to <=38.9 degrees C	2.7 2.7%
Fever:>=39.0 degrees C to <=40.0 degrees C	0 0%
Fever: >40.0 degrees C	0 0%
Fatigue: Any	31.2 31.2%
Fatigue: Mild	22.1 22.1%
Fatigue: Moderate	6.5 6.5%
Fatigue: Severe	2.6 2.6%
Headache: Any	25.0 25%
Headache: Mild	15.8 15.8%
Headache: Moderate	6.6 6.6%
Headache: Severe	2.6 2.6%
Muscle pain: Any	27.3 27.3%
Muscle pain: Mild	20.8 20.8%
Muscle pain: Moderate	3.9 3.9%
Muscle pain: Severe	2.6 2.6%
Joint pain: Any	13.0 13%
Joint pain: Mild	3.9 3.9%
Joint pain: Moderate	7.8 7.8%
Joint pain: Severe	1.3 1.3%
Vomiting: Any	9.6 9.6%
Vomiting: Mild	8.2 8.2%
Vomiting: Moderate	1.4 1.4%
Vomiting: Severe	0 0%
Diarrhea: Any	4.1 4.1%
Diarrhea: Mild	2.7 2.7%
Diarrhea: Moderate	1.4 1.4%
Diarrhea: Severe	0 0%

3. Primary Outcome

Title	Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	up to 1 month after vaccination on Day 1

Outcome Measure Data

Analysis Population Description

The safety population included all participants who received 1 dose of an investigational product.

Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Measure Participants	100
AEs	75.0 75%
SAEs	1.0 1%

Adverse Events

Time Frame	up to 1 month after vaccination on Day 1
Adverse Event Reporting Description	Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Arm/Group Title	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
Arm/Group Description	Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
All Cause Mortality
	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Serious Adverse Events
	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
	Affected / at Risk (%)	# Events
Total	1/100 (1%)
Hepatobiliary disorders
Hepatitis acute	1/100 (1%)
Other (Not Including Serious) Adverse Events
	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine
	Affected / at Risk (%)	# Events
Total	75/100 (75%)
Gastrointestinal disorders
Diarrhoea	1/100 (1%)
General disorders
Diarrhoea	3/73 (4.1%)
Vomiting	7/73 (9.6%)
Fatigue	24/77 (31.2%)
Fever	3/73 (4.1%)
Joint pain	10/77 (13%)
Muscle pain	21/77 (27.3%)
Headache	19/76 (25%)
Infections and infestations
Nasopharyngitis	1/100 (1%)
Rhinitis	1/100 (1%)
Upper respiratory tract infection	2/100 (2%)
Skin and subcutaneous tissue disorders
Pruritus	1/100 (1%)
Pain at the injection site	61/91 (67%)
Redness	11/74 (14.9%)
Swelling	13/74 (17.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.