A Phase 4 interventional study of 13vPnC in Vaccines, sponsored by Pfizer. Completed at 4 sites in India. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Pfizer · Phase 4, Interventional, and Prevention
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.
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Child who is a family member of:
All subjects receive a single dose (0.5mL) of 13vPnC
Biological: 13vPnC
All subjects receive a single dose (0.5mL) of 13vPnC
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.
Time frame: 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.)
Time frame: 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.
Time frame: up to 1 month after vaccination on Day 1
| Milestone | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Started | 100 |
| Completed | 100 |
| Not completed | 0 |
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.
| percentage of participants | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Redness: Any | 14.9 (7.7 to 25.0) |
| Redness: Mild | 14.9 (7.7 to 25.0) |
| Redness: Moderate | 0 (0.0 to 4.9) |
| Redness: Severe | 0 (0.0 to 4.9) |
| Swelling: Any | 17.6 (9.7 to 28.2) |
| Swelling: Mild | 17.6 (9.7 to 28.2) |
| Swelling: Moderate | 0 (0.0 to 4.9) |
| Swelling: Severe | 0 (0.0 to 4.9) |
| Pain: Any | 67.0 (56.4 to 76.5) |
| Pain: Mild | 45.1 (34.6 to 55.8) |
| Pain: Moderate | 19.8 (12.2 to 29.4) |
| Pain: Severe | 2.2 (0.3 to 7.7) |
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.)
| percentage of participants | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Fever: >=38 degrees C | 4.1 (0.9 to 11.5) |
| Fever: >=38 degrees C to <=38.4 degrees C | 1.4 (0.0 to 7.4) |
| Fever:>=38.5 degrees C to <=38.9 degrees C | 2.7 (0.3 to 9.5) |
| Fever:>=39.0 degrees C to <=40.0 degrees C | 0 (0.0 to 4.9) |
| Fever: >40.0 degrees C | 0 (0.0 to 4.9) |
| Fatigue: Any | 31.2 (21.1 to 42.7) |
| Fatigue: Mild | 22.1 (13.4 to 33.0) |
| Fatigue: Moderate | 6.5 (2.1 to 14.5) |
| Fatigue: Severe | 2.6 (0.3 to 9.1) |
| Headache: Any | 25.0 (15.8 to 36.3) |
| Headache: Mild | 15.8 (8.4 to 26.0) |
| Headache: Moderate | 6.6 (2.2 to 14.7) |
| Headache: Severe | 2.6 (0.3 to 9.2) |
| Muscle pain: Any | 27.3 (17.7 to 38.6) |
| Muscle pain: Mild | 20.8 (12.4 to 31.5) |
| Muscle pain: Moderate | 3.9 (0.8 to 11.0) |
| Muscle pain: Severe | 2.6 (0.3 to 9.1) |
| Joint pain: Any | 13.0 (6.4 to 22.6) |
| Joint pain: Mild | 3.9 (0.8 to 11.0) |
| Joint pain: Moderate | 7.8 (2.9 to 16.2) |
| Joint pain: Severe | 1.3 (0.0 to 7.0) |
| Vomiting: Any | 9.6 (3.9 to 18.8) |
| Vomiting: Mild | 8.2 (3.1 to 17.0) |
| Vomiting: Moderate | 1.4 (0.0 to 7.4) |
| Vomiting: Severe | 0 (0.0 to 4.9) |
| Diarrhea: Any | 4.1 (0.9 to 11.5) |
| Diarrhea: Mild | 2.7 (0.3 to 9.5) |
| Diarrhea: Moderate | 1.4 (0.0 to 7.4) |
| Diarrhea: Severe | 0 (0.0 to 4.9) |
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.
| percentage of participants | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| AEs | 75.0 (65.3 to 83.1) |
| SAEs | 1.0 (0.0 to 5.4) |
Collected over up to 1 month after vaccination on Day 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine | 0/100 (0%) | 1/100 (1%) | 75/100 (75%) |
| Event | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Hepatitis acuteHepatobiliary disorders | 1/100 |
| Event | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Pain at the injection siteSkin and subcutaneous tissue disorders | 61/91 |
| FatigueGeneral disorders | 24/77 |
| Muscle painGeneral disorders | 21/77 |
| HeadacheGeneral disorders | 19/76 |
| SwellingSkin and subcutaneous tissue disorders | 13/74 |
| RednessSkin and subcutaneous tissue disorders | 11/74 |
| Joint painGeneral disorders | 10/77 |
| VomitingGeneral disorders | 7/73 |
| DiarrhoeaGeneral disorders | 3/73 |
| FeverGeneral disorders | 3/73 |
The safety population included all participants who received 1 dose of an investigational product.
| Age, Continuous(years) | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Mean | 10.28 ± 2.985 |
| Sex: Female, Male(Participants) | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Female | 47 |
| Male | 53 |
| Ethnicity (NIH/OMB)(Participants) | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 100 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 13-Valent Pneumococcal Conjugate (13vPnC) Vaccine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 100 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
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