Clinical Trial Results:
A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20-vPnC) IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
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Summary
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EudraCT number |
2021-006624-41 |
Trial protocol |
HU ES PL |
Global end of trial date |
01 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Dec 2023
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First version publication date |
14 Dec 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B7471027
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05408429 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
66 Hudson Boulevard East, New York, United States, NY 10001
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002330-PIP01-18 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Aug 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the safety and immunogenicity of 1 or 2 doses of 20vPnC in toddlers greater than or equal to (>=) 12 to less than (<) 24 months of age who have received 2 doses of 13vPnC in infancy (prior to 12 months of age).
Safety assessments included local reactions, systemic events and adverse events. Immunogenicity assessments included percentage of subjects with pre-defined IG concentrations, IgG GMCs and OPA GMTs 1 month after the last vaccination.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Jun 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 124
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Country: Number of subjects enrolled |
Poland: 70
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Country: Number of subjects enrolled |
Spain: 162
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Worldwide total number of subjects |
356
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EEA total number of subjects |
356
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
356
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects included in this study were toddlers >=12 to less than <24 months of age who had received 2 doses of 13vPnC (Prevenar 13®) in infancy (prior to 12 months of age). | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
356 subjects were enrolled and randomized to receive either 2 dose of 20vPnC, 1 dose of 20vPnC or 1 dose of 13vPnC. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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2-Dose 20vPnC | ||||||||||||||||||||||||
Arm description |
Toddlers >=12 to <24 months of age were randomised to receive 2 doses of 0.5 millilter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
20vPnC
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Investigational medicinal product code |
PF-06482077
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5 mL dose of 20vPnC intramuscularly each on Day 1 (Dose 1 Visit 1) and 56 to 70 days later (Dose 2 Visit).
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Arm title
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1-Dose 20vPnC | ||||||||||||||||||||||||
Arm description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
20vPnC
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Investigational medicinal product code |
PF-06482077
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5 mL dose of 20vPnC intramuscularly each on Day 1 (Dose 1 Visit 1).
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Arm title
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13vPnC Control | ||||||||||||||||||||||||
Arm description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
13-Valent Pneumococcal Conjugate Vaccine
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Investigational medicinal product code |
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Other name |
Prevenar 13®
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5 mL dose of 13vPnC intramuscularly each on Day 1 (Dose 1 Visit 1).
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Baseline characteristics reporting groups
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Reporting group title |
2-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 2 doses of 0.5 millilter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
13vPnC Control
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
2-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 2 doses of 0.5 millilter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). | ||
Reporting group title |
1-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||
Reporting group title |
13vPnC Control
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Reporting group description |
Toddlers >=12 to <24 months of age were randomised to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||
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End point title |
Percentage of Subjects With Local Reactions Within 7 Days After Last Vaccination [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Local reactions included redness, swelling, and pain at the injection site, recorded by parents/legal guardians of subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. Safety analysis set included all subjects who received at least 1 dose of 20vPnC or 13vPnC and had safety data reported after any dose. Here, “Number of subjects Analyzed” signifies the number of subjects with any e-diary data reported after the last vaccination.
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End point type |
Primary
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End point timeframe |
Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Systemic Events Within 7 Days After Last Vaccination [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events included fever, decreased appetite, drowsiness/increased sleep & irritability, recorded by parents/legal guardians of subjects using an e-diary. Fever: temperature >=38.0 degree Celsius (C) & categorized as >=38.0 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% confidence interval (CI) was based on Clopper & Pearson method. Safety analysis set was analyzed. “Number of subjects Analyzed”=number of subjects with any e-diary data reported after the last vaccination.
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End point type |
Primary
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End point timeframe |
Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination [3] | ||||||||||||||||
End point description |
An AE was any untoward medical occurrence in a subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary. Safety analysis set included all subjects who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, “Number of subjects Analysed” signifies the number of subjects in the specified group that received the last vaccination.
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End point type |
Primary
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End point timeframe |
From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination [4] | ||||||||||||||||
End point description |
A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method. Safety analysis set included all subjects who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, “Number of subjects Analysed” signifies the number of subjects in the specified group that received the last vaccination.
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End point type |
Primary
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End point timeframe |
1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination [5] | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method. Evaluable immunogenicity population included all subjects who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. "Number of subjects analysed"= subjects in evaluable immunogenicity population. "n"= subjects with valid IgG results for specified serotype.
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End point type |
Primary
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End point timeframe |
1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5*LLOQ. GMC & corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Evaluable immunogenicity population included all subjects who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. Number of Subjects Analysed= subjects in evaluable immunogenicity population. "n"= subjects with valid IgG assay results for specified serotype.
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End point type |
Secondary
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End point timeframe |
1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects with Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes:1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,19A,19F, 23F. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method. Evaluable immunogenicity population included all subjects who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after last assigned vaccination collected within 27 to 56 days after dose, had no other major protocol deviations. Number of Subjects Analysed= subjects in evaluable immunogenicity population. “n"=subjects with valid IgG results for specified serotype.
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End point type |
Secondary
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End point timeframe |
1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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End point title |
Serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of subjects at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. Evaluable immunogenicity population included all subjects who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. "Number of Subjects Analysed"= subjects in evaluable immunogenicity population with any valid OPA titers for the specified group, "n"= subjects with valid OPA assay results for specified serotype.
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End point type |
Secondary
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End point timeframe |
1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
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Adverse events information
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Timeframe for reporting adverse events |
Local reactions & Systemic events: Within 7 days after each vaccination; SAEs & non-SAEs: from study dose to 1 month (M) after last dose. Results are summarized by: 2-Dose 20vPnC Dose(D) 1 to D2, 2-Dose 20vPnC (D2 to 1M after),1-Dose 20vPnC,13vPnC Control
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Adverse event reporting additional description |
Same event may appear as both SAE & non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 subject & non-serious in another, or 1 subject may have experienced both during study. Local reactions/systemic events collected by systematic assessment (SA);SAE/non-SAEs collected by non-SA. Safety analysis set analysed.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
2-Dose 20vPnC Dose 1 to Dose 2
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Reporting group description |
Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
2-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1-Dose 20vPnC
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Reporting group description |
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
13vPnC Control
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Reporting group description |
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
