Trial Outcomes & Findings for Study To Describe The Safety Of 13-valent Pneumococcal Conjugate Vaccine In Children 6 To 17 Years Of Age In India (NCT NCT03777865)

Last Updated: 2020-04-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2020-04-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine Participants received a single dose of 0.5 milliliter (mL) 13vPnC vaccine, intramuscularly on Day 1.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=100 Participants Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Age, Continuous	10.28 years STANDARD_DEVIATION 2.985 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	100 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=92 Participants Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Redness: Any	14.9 percentage of participants Interval 7.7 to 25.0
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Redness: Mild	14.9 percentage of participants Interval 7.7 to 25.0
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Redness: Moderate	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Redness: Severe	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Swelling: Any	17.6 percentage of participants Interval 9.7 to 28.2
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Swelling: Mild	17.6 percentage of participants Interval 9.7 to 28.2
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Swelling: Moderate	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Swelling: Severe	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Pain: Any	67.0 percentage of participants Interval 56.4 to 76.5
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Pain: Mild	45.1 percentage of participants Interval 34.6 to 55.8
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Pain: Moderate	19.8 percentage of participants Interval 12.2 to 29.4
Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination Pain: Severe	2.2 percentage of participants Interval 0.3 to 7.7

PRIMARY outcome

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

Population: 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.

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.)

Outcome measures

Outcome measures
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=83 Participants Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fever: >=38 degrees C	4.1 percentage of participants Interval 0.9 to 11.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fever:>=38.5 degrees C to <=38.9 degrees C	2.7 percentage of participants Interval 0.3 to 9.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fever:>=39.0 degrees C to <=40.0 degrees C	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fever: >40.0 degrees C	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fatigue: Any	31.2 percentage of participants Interval 21.1 to 42.7
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fatigue: Mild	22.1 percentage of participants Interval 13.4 to 33.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fatigue: Moderate	6.5 percentage of participants Interval 2.1 to 14.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fatigue: Severe	2.6 percentage of participants Interval 0.3 to 9.1
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Headache: Any	25.0 percentage of participants Interval 15.8 to 36.3
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Headache: Moderate	6.6 percentage of participants Interval 2.2 to 14.7
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Headache: Severe	2.6 percentage of participants Interval 0.3 to 9.2
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Muscle pain: Mild	20.8 percentage of participants Interval 12.4 to 31.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Muscle pain: Moderate	3.9 percentage of participants Interval 0.8 to 11.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Muscle pain: Severe	2.6 percentage of participants Interval 0.3 to 9.1
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Joint pain: Any	13.0 percentage of participants Interval 6.4 to 22.6
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Joint pain: Mild	3.9 percentage of participants Interval 0.8 to 11.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Joint pain: Moderate	7.8 percentage of participants Interval 2.9 to 16.2
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Joint pain: Severe	1.3 percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Vomiting: Any	9.6 percentage of participants Interval 3.9 to 18.8
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Vomiting: Mild	8.2 percentage of participants Interval 3.1 to 17.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Vomiting: Moderate	1.4 percentage of participants Interval 0.0 to 7.4
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Vomiting: Severe	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Diarrhea: Any	4.1 percentage of participants Interval 0.9 to 11.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Diarrhea: Mild	2.7 percentage of participants Interval 0.3 to 9.5
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Diarrhea: Moderate	1.4 percentage of participants Interval 0.0 to 7.4
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Diarrhea: Severe	0 percentage of participants Interval 0.0 to 4.9
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Fever: >=38 degrees C to <=38.4 degrees C	1.4 percentage of participants Interval 0.0 to 7.4
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Headache: Mild	15.8 percentage of participants Interval 8.4 to 26.0
Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination Muscle pain: Any	27.3 percentage of participants Interval 17.7 to 38.6

PRIMARY outcome

Timeframe: up to 1 month after vaccination on Day 1

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

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.

Outcome measures

Outcome measures
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=100 Participants Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	75.0 percentage of participants Interval 65.3 to 83.1
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1.0 percentage of participants Interval 0.0 to 5.4

Adverse Events

13-Valent Pneumococcal Conjugate (13vPnC) Vaccine

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=100 participants at risk Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Hepatobiliary disorders Hepatitis acute	1.0% 1/100 • up to 1 month after vaccination on Day 1 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.

Other adverse events

Other adverse events
Measure	13-Valent Pneumococcal Conjugate (13vPnC) Vaccine n=100 participants at risk Participants received a single dose of 0.5 mL 13vPnC vaccine, intramuscularly on Day 1.
Gastrointestinal disorders Diarrhoea	1.0% 1/100 • up to 1 month after vaccination on Day 1 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.
Infections and infestations Nasopharyngitis	1.0% 1/100 • up to 1 month after vaccination on Day 1 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.
Infections and infestations Rhinitis	1.0% 1/100 • up to 1 month after vaccination on Day 1 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.
Infections and infestations Upper respiratory tract infection	2.0% 2/100 • up to 1 month after vaccination on Day 1 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.
Skin and subcutaneous tissue disorders Pruritus	1.0% 1/100 • up to 1 month after vaccination on Day 1 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.
General disorders Diarrhoea	4.1% 3/73 • up to 1 month after vaccination on Day 1 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.
General disorders Vomiting	9.6% 7/73 • up to 1 month after vaccination on Day 1 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.
General disorders Fatigue	31.2% 24/77 • up to 1 month after vaccination on Day 1 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.
General disorders Fever	4.1% 3/73 • up to 1 month after vaccination on Day 1 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.
General disorders Joint pain	13.0% 10/77 • up to 1 month after vaccination on Day 1 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.
General disorders Muscle pain	27.3% 21/77 • up to 1 month after vaccination on Day 1 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.
Skin and subcutaneous tissue disorders Pain at the injection site	67.0% 61/91 • up to 1 month after vaccination on Day 1 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.
Skin and subcutaneous tissue disorders Redness	14.9% 11/74 • up to 1 month after vaccination on Day 1 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.
Skin and subcutaneous tissue disorders Swelling	17.6% 13/74 • up to 1 month after vaccination on Day 1 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.
General disorders Headache	25.0% 19/76 • up to 1 month after vaccination on Day 1 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER